44 Adverse Events 44 Clinical Project Management 45 ...

44 AdverseEvents

44 Clinical ProjectManagement

45 Custom ApplicationDevelopment

46 Data Collection/Management

48 Data Mining andVisualization

48 DataWarehousing

49 DocumentManagement

50 Electronic DataCapture (EDC)

52 ElectronicSubmissions

54 IT Consulting

54 KnowledgeManagement

55 MedicalImaging

55 StatisticalAnalysis

56 Training

56 Trials Management/Administration

57 Validation

57 Web-BasedSoftware Services

58 Wireless/MobileTechnologies

58 OtherApplications

44 APPLIED CLINICAL TRIALS August 2001

Clinical ProjectManagement

AEC Software 22611-113 Markey Ct., Sterling, VA20166, USA, (703) 450-1980, fax (703) 450-9786, e-mail: [email protected], www.aecsoft.com

Details 3.0 See Data Collection/Management

FastTrack Schedule 7.0 FastTrack Schedule 7.0 deliverstools to organize tasks, meet deadlines, and achieveproject goals. This award-winning program creates clear,precise schedules, calendars, and resource graphs withease. Outline activities for multiple clinical projects,establish task dependencies—even track people, equip-ment, and costs. FastTrack Schedule 7.0 is available forMacintosh, Windows, and Palm OS.

Araccel CorporationAraccel Solutions Platform See Electronic Data Capture(EDC)

Axio Research CorporationInternet-based data management services See DataCollection/Management

Biostat, Inc.Power And Precision See Statistical Analysis

Cardiff Software, Inc.LiquidOffice See Electronic Submissions

TELEform See Data Collection/Management

Cardinal systemsCRFSuite and DBMSuite See Electronic Data Capture(EDC)

Clinarium 2777 Summer St., Stamford, CT 06902,USA, (203) 588-3000, fax (203) 356-1673, e-mail:[email protected], www.clinarium.com

e-TRIALS e-TRIALS is a comprehensive Web-based clini-cal trials management system that enables you to plan,track, and control the entire clinical trials process, fromprotocol design to completion of the final report, whileutilizing the Internet for global trial participation andreal-time information exchange.

ClinicalTrialsNet Inc.ClinTriNet See Web-Based Software Services

ClinPhone Group Ltd. Lady Bay House, MeadowGrove, Nottingham NG2 3HF, UK, +44 115 9557333 or(609) 620-7000 (USA), fax +44 115 9557555, e-mail:[email protected], www.clinphone.com

Providing IT solutions that accelerate the drug develop-ment process, ClinPhone applications include IVR, EDC,and ePatient Diaries. These services allow sponsors totrack study progress, collect clinical subject data,manage drug supply, and screen/randomize patients.These applications are reported in real-time using aWeb-based client interface. ClinPhone—making the clini-cal trial connection.

Clinsoft CorporationClintrial, Clintrial Connect, Clintrace See Trials Manage-ment/Administration

CompleWare CorporationWebCRF See Electronic Data Capture (EDC)

CRF Box Ltd.CRF Box Wireless See Electronic Data Capture (EDC)

DataLabs 17310 Redhill Ave., Ste. 200, Irvine, CA92614, USA, (949) 851-2030, fax (949) 851-2043, e-mail: [email protected], www.datalabsinc.com

DataLabs CTMS DataLabs CTMS is the first Internet-based product that integrates the elements of project,data, and document management into a single applica-tion. Based in Microsoft’s NET framework and servers,this integrated approach provides significant benefits,including an accelerated time to market, lower develop-ment costs, and improved research quality.

Datapharm Australia Pty. Ltd. 56-56AThompson St., Drummoyne, NSW 2047, Australia, +612 9719 2800, fax +61 2 9719 2811, e-mail:[email protected], www.datapharm.com.au

SMART SMART (Smooth Monitoring A Resource Tool)was developed by Datapharm to assist projectmanagers of clinical trials to assess and track monitor-ing requirements over several projects and to adjustestimates based on actuals iteratively. It is quick to useand allows monitoring of actuals vs. estimated progress

Adverse EventsAcumen Healthcare Solutions, LLCTracIt2k EDC System See Electronic Data Capture (EDC)

BioObjects, Inc.Web Services See Web-Based Software Services


Clinarium 2777 Summer St., Stamford, CT 06902,USA, (203) 588-3000, fax (203) 356-1673, e-mail:[email protected], www.clinarium.com

ARISg ARISg is an advanced drug safety surveillancesystem designed to meet the regulatory requirementsfor the global collection, assessment, reporting, andanalysis of clinical and postmarketing adverse eventdata.



DataLabsDataLabs CTMS See Clinical Project Management

DataScout Software, Inc.IVRQuest See Clinical Project Management

Dendrite International, Inc.eClinical Global Deployment Facilitators See ElectronicData Capture (EDC)

eResearchTechnology, Inc.eResearch Network and Community Technologies SeeElectronic Data Capture (EDC)

INC ResearchClinical Drug Development Services See Data Collection/Management

LifeTree Technology, LLCLifeTree ICTM See Electronic Data Capture (EDC)

MAJARO InfoSystems Inc.ClinAccess Casebook See Data Collection/Management

ClinAccess Dictionary Coder See Data Collection/Management

ClinAccess PowerServer See Data Collection/Management

ClinAccess SureStart See Data Collection/Management

ClinAccess Web Component See Data Collection/Management

MarCon Global Data Solutions, Inc.See Clinical Project Management

NetRegulus One Tower Lane, Ste. 1700, OakbrookTerrace, IL 60181, USA, (888) 707-6900, fax (630)573-6050, e-mail: [email protected], www.netregulus.com

ActivityExpert See Electronic Data Capture (EDC)

IssueExpert IssueExpert provides all the tools andcapabilities necessary for collecting, documenting,tracking, trending, and reporting product quality issuesincluding adverse events, CAPA management, auditmanagement, complaints, nonconformities, vigilancereporting, product tracking, and more. This 21 CFR11–compliant module is available as a client-server or

Internet-intranet application.

PQIntelligence See Knowledge Management

RegistryExpert See Data Collection/Management

ReportExpert See Data Mining and Visualization

TrackExpert See Data Collection/Management

OmniComm Systems, Inc.TrialMaster See Data Collection/Management

Phase Forward IncorporatedInForm See Electronic Data Capture (EDC)

ProIRB Plus, Inc.PRO_IRB See Trials Management/Administration

QED Solutions, Inc. 8300 Greensboro Dr., Ste.970, McLean, VA 22102, USA, (703) 821-3200, fax(703) 821-0600, e-mail: [email protected],www.qedrx.com

Qscan QED Solutions specializes in lifecycle drug safetymanagement and pharmacovigilance. QED has devel-oped a host of software platforms to support dataconversion and cleanup, coding, and analysis. Qscan isan integrated offering, which includes data, tools, and a“Q” Team that acts as an extension of a biopharmaceu-tical research department.

StudyBuilder B.V.StudyBuilder Enterprise Edition See Electronic DataCapture (EDC)

Synteract 187 Calle Magdalena, Encinitas, CA92024, USA, (760) 634-2133, fax (760) 634-2170, e-mail: [email protected], www.synteract.com

SynCoder SynCoder is an SAS application that imple-ments the MedDRA terminology, as well as COSTARTand WHO-DRUG dictionaries, for coding adverse eventand medication text reported during clinical trials orpostmarketing. The product requires SAS v8.1 or higher,and works with SAS v6 or v8 databases.

TrialTrac, Inc.SiteTrac See Trials Management/Administration

TrialWorks See Trials Management/Administration

Winchester Business Systems, Inc. 50Cross St., Winchester, MA 01890, USA, (781) 729-7150, fax (781) 729-7211, e-mail: [email protected],www.wbsnet.com

adWatch adWatch helps the clinical trial team track AEsand SAEs as well as product inquiries and complaintsfrom around the world. Integrates seamlessly with Proto-col Manager, our clinical trials management system.Automatically generates CIOMS and MEDWATCH 3500reports for electronic submission.

Custom application development See Custom ApplicationDevelopment

Health Agency Tracking See Document Management

Product Complaint Management Product ComplaintManagement System documents the product inquiryand complaint lifecycle for medical devices. Systemmanages product registration, inquiries, complaints,investigations, return material authorizations, repairs,adverse events, medical device reports, CIOMS,MEDWATCH 3500, and customer notifications. Meets21 CFR 11 requirements for electronic submission.

Protocol Manager See Clinical Project Management

The Applied Clinical Trials 2001 IT Solutions Directory presents informationabout applications used in the conduct of clinical trials. It is compiled frominformation provided by application developers, and Applied Clinical Trialscannot accept responsibility for the accuracy of the information they supplied.

August 2001 APPLIED CLINICAL TRIALS 45

milestones.

DataScout Software, Inc. 6817 Falls of theNeuse Rd., Ste. 106, Raleigh, NC 27615, USA, (919)866-1712 ext. 13, or (919) 866-1712 ext. 14, fax (919)866-1727, e-mail: [email protected],www.datascoutsoftware.com

IVRQuest IVRQuest is innovative interactive voice (IVR)and Web response software for clinical research.IVRQuest accelerates study initiation while ensuringcompliance with 21 CFR 11 for electronic records.IVRQuest is configurable for management of multiplemultilingual IVR processes for randomization, enroll-ment, subject diaries, EDC, site activation, and clinicalsupply requests.

DATATRAKDATATRAK EDC See Electronic Data Capture (EDC)


ETRAC Solutions, Inc. One Martin Ave., CherryHill, NJ 08002, USA, (856) 662-1290, fax (856) 662-8540, e-mail: [email protected], www.etracsolutions.com

Project Management Solutions ETRAC Solutions, Inc. isan international consulting and software sales organiza-tion specializing in the implementation of projectmanagement solutions and enterprise resourceplanning. We offer an extensive curriculum of programscovering project management concepts and methodol-ogy, expert process consulting, Primavera certified train-ing, and sales of project management software.

First Consulting GroupFirstDocs for CRFs See Document Management

Fortress Medical Systems, Inc.Clindex 2.0 See Data Collection/Management

FW Pharma SystemsIMPACT See Trials Management/Administration

INITIATOR See Trials Management/Administration

Health Care Online, Inc.HCOL Clinical Study Enterprise Edition See ElectronicData Capture (EDC)

iBiomaticsP21 Biomedical Knowledge Platform See Data Ware-housing

idv Data Analysis & Study Planning Wesso-brunner Str. 6, 82131 Gauting/Munich, Germany, +4989 8508001, fax +49 89 8503666, e-mail: [email protected]

ICH-Study-Report-Manager Systems supported: Windows95/98/2000/NT/ME. This program dramaticallyspeeds the creation of a clinical research reportconforming to ICH guidelines. It is directly implementedinto Word and offers: default phrases, hundreds ofpredefined tables for depicting results, easy inclusion offigures and text files.

N See Statistical Analysis

Nnpar 1.0 See Statistical Analysis

Nsurv See Statistical Analysis

Rancode Prof. See Statistical Analysis

iMedRIS Data Corp.Study Assistant See Data Collection/Management


Insightful CorporationS-PLUS and SeqTrial, Server Products See StatisticalAnalysis

Invantage, Inc.Investigator DataWeb System See Trials Management/Administration







Datapharm Australia Pty. Ltd.SMART See Clinical Project Management

Datasential LLCTrialOne Services See Electronic Data Capture (EDC)



Intrasphere Technologies, Inc.Systems Integration See IT Consulting

Kronos Communicated Data, Inc. 860Lower Ferry Rd., Trenton, NJ 08628, USA, (888) 538-1690 or (609) 538-9205, fax (609) 538-9208, e-mail:[email protected], www.kronosdata.com

APERS Reduce time to locked database with IVR andWeb-based platforms for real-time enrollment, random-ization, study drug management, and subject diaries.Specializing in systems tailored to maximize study teameffectiveness, these fully supported systems are deliv-ered in three to six weeks.

OutcomesCall Reduce time to locked database with IVRand Web-based platforms for real-time enrollment,randomization, study drug management, and subjectdiaries. Specializing in systems tailored to maximizestudy team effectiveness, these fully supportedsystems are delivered in three to six weeks.






NetRegulusActivityExpert See Electronic Data Capture (EDC)

IssueExpert See Adverse Events




StudyExpert See Trials Management/Administration


Numoda CorporationNumoda mTrial See Wireless/Mobile Technologies


Propack Data Corp.PMX CTM Solution See Trials Management/Administration



MarCon Global Data Solutions, Inc. 2736NW 22nd Terrace, Gainesville, FL 32605, USA, (352)870-9843, fax (352) 378-5526, e-mail: [email protected], www.marconglobal.com

MarCon’s Web-based clinical research managementsystem centralizes and coordinates clinical trialsprocesses, including EDC, IRB, randomization, medica-tion distribution, compensation, AE reporting, andprovides comprehensive reports for sponsors, sites,and monitors to maximize trial efficiency and accuracy.The MarCon system enhances subject safety throughcoordination of trial safety processes.














Valid Systems IncorporatedRecords Manager for Lotus Notes Mail See KnowledgeManagement

Winchester Business Systems, Inc. 50Cross St., Winchester, MA 01890, USA, (781) 729-7150, fax (781) 729-7211, e-mail: [email protected], www.wbsnet.com

adWatch See Adverse Events



Protocol Manager Protocol Manager is a fully functionalWeb-enabled software suite that helps an entire trialteam (sponsor, CRO, SMO, site, investigator, and CRA)manage all documents associated with clinical trials—all investigator documents, protocol documents, inven-tory, SOPs, subject recruiting, SAEs, and financials.Validation software is included.

Custom ApplicationDevelopment


BBK Healthcare, Inc.TrialCentral.net See Knowledge Management


CB Technologies, Inc.MetaTrial See Electronic Data Capture (EDC)

ClickFind MEDClickTrials See Web-Based Software Services


ClinPhone Group Ltd.See Clinical Project Management

Check Your InformationIf you submitted information for the 2001

IT Solutions directory, please carefullyexamine your listings, and contact us

about any problems.

If necessary, we will publish an adden-dum with corrected information in a sub-

sequent ACT issue.

Send corrections to IT Solutions EditorApplied Clinical Trials859 Willamette Street

Eugene, OR 97401-6806fax: (541) 984-5250

e-mail: [email protected]


their own studies and data entry systems, collect andmonitor data, manage and compensate physicians,report on data, and interface to statistical packages.Clindex is the clinical trial in a box solution!


iBiomaticsPH.Dataware See Data Warehousing

iMedRIS Data Corp. 36213 Highland Ave.,Yucaipa, CA 92399, USA, (909) 520-9164, fax (909)797-3100, e-mail: [email protected], www.imedris.com

Study Assistant iMedRis has designed an applicationthat integrates clinical study management and datacapture. Sites now have the ability to manage allaspects of clinical studies including subject data, studyinformation, visit tracking, screening, reporting, andbudget/financial information while having the ability todesign, capture, and export data into other applications.

INC Research 6131 Falls of the Neuse Rd., Ste.200, Raleigh, NC 27609, USA, (919) 876-9300, fax(919) 876-9360, e-mail: [email protected],www.incresearch.com

Clinical Drug Development Services INC Research, a full-service contract research organization, manages allaspects of clinical drug development programs forpharmaceutical and biotechnology companies develop-ing drugs and devices used for disorders of the centralnervous system. In addition, we have specialized experi-ence in providing clinical data services across all thera-peutic areas.

InferMed LimitedMACRO See Electronic Data Capture (EDC)


invivodata, inc. 5615 Scotts Valley Dr., Ste. 150,Scotts Valley, CA 95066, USA, (831) 438-9550, fax(831) 440-1770, e-mail: [email protected],www.invivodata.com

invivosystem The invivosystem is a subject-focusedsolution for collecting real-time, real-world subjectexperience data for clinical research that is valid,reliable, and timely. Using hand-held technology,invivosystem supports all study phases by applyinghuman factors and concepts from clinical psychology tofacilitate subject compliance and collection of validdata.

Kronos Communicated Data, Inc.APERS See Custom Application Development

OutcomesCall See Custom Application Development


Logos Technologies Ltd.ALPHADAS See Electronic Data Capture (EDC)

SMART Patient Diary Card See Electronic Data Capture(EDC)

MAJARO InfoSystems Inc. 1731 TechnologyDr., Ste. 560, San Jose, CA 95110, USA, (408) 562-1890 or (714) 985-9661, fax (408) 562-1899, e-mail:[email protected], www.majaro.com

ClinAccess Casebook Imaging system written specificallyfor clinical data management. Integrates with Clin-Access PowerServer or as stand alone. Images receivedvia fax, scan, or from file. Images tie directly to data;CRF dynamically appears throughout. Integrates withstandard e-mail systems, fax servers, and Web. Trackscorrespondence and other files (i.e., scans, videoimages).

ClinAccess Dictionary Coder SAS-powered. Integrateswith ClinAccess or as standalone. Works with any dictio-nary, including MedDRA, COSTART, WHO, or custom-built. Autoencodes exact matches. Flexible term search,learning capabilities, entered word as replacement, etc.,to assist with uncoded terms. Variety of reports. Usedwith entire system, images dynamically appear for easycoding.

ClinAccess PowerServer Validated SAS-powered clinicaldata management software with integrated dictionaryautoencoder, data clarification system, workflow,

QED Solutions, Inc.Qscan See Adverse Events




Vitalograph Ltd.Electronic PEF/FEV1 Diary See Electronic Data Capture(EDC)

Spirotrac Centralized Spirometry System See ElectronicData Capture (EDC)



Custom application development Winchester BusinessSystems develops software applications for pharma-ceutical, biotechnology, and medical device companiesthat are designed to improve drug and product develop-ment processes. Winchester employs LotusNotes/Domino technology for multisite/multivendorclinical trials projects, electronic data collection,workflow management and project managementsystems, information management, and exceptionreporting for decision support.


paraFILE See Document Management

Product Complaint Management See Adverse Events


Zurich Biostatistics, Inc.Tekoa XML Automation Technology See Statistical Analysis

Tekoa XML Technology See Data Collection/Management

Data Collection/Management

Acumen Healthcare Solutions, LLCTracIt2k EDC System See Electronic Data Capture (EDC)

Adapt~EDC, LLC 5872 York Rd., PO Box 663,Lahaska, PA 18931, USA, (215) 794-8028, fax (215)794-8028, e-mail: [email protected], www.adaptedc.com

Adapt~EDC Clinical Trials Suite Adapt~EDC serves thepharmaceutical and biotechnology industries by develop-ing and supporting advanced software applications andoutsourcing services designed to dramatically reducethe costs and time associated with the collection, distri-bution, and analysis of clinical trial data. Adapt~EDCenables companies to make go, no-go decisions muchearlier than ever before possible.

AEC Software 22611-113 Markey Ct., Sterling, VA20166, USA, (703) 450-1980, fax (703) 450-9786, e-mail: [email protected], www.aecsoft.com

Details 3.0 Make your project information work for you!With Details, your clinical project information is central-ized, organized, and always up-to-date. Instantly commu-nicate project statuses to colleagues and clients withpresentation-quality reports and colorful, custom forms.You’ll be amazed at how quickly and easily you cancapture, track, and route project details.

Analyse-it Software, Ltd.Analyse-it Clinical Laboratory See Statistical Analysis


Axio Research Corporation 2601 Fourth Ave.,Ste. 200, Seattle, WA 98121, USA, (206) 547-2829,fax (206) 547-4671, e-mail: [email protected],www.axioresearch.com

Internet-based data management services Axio Researchprovides expert data management and statisticalservices for Internet-based clinical trials using ourproprietary trial management system. Contact us tolearn if our expertise coupled with the power of the

Internet can provide speed, quality, and cost savings foryour next trial.

Cardiff Software, Inc. 3220 Executive RidgeDr., Vista, CA 92083, USA, (760) 936-4500, fax (760)936-4800, e-mail: [email protected], www.cardiff.com

LiquidOffice See Electronic Submissions

TELEform TELEform streamlines collection of data frompaper and online forms. Built-in business rules andintuitive validation processes help you quickly captureaccurate information. Operators spend seconds verifyingdata rather than minutes manually keying entire forms.Connects to leading clinical database applications,including SAS, SPSS, Oracle Clinical, and Clintrial.




Clinical DataFax Systems Inc. 21 King St.West, Ste. 305, Hamilton, ON L8P 4W7, Canada, (905)522-3282, fax (905) 522-7284, email: [email protected], www.datafax.com

DataFax A complete clinical trials management solutionusing CRFs and simple fax technology at the clinicalsites and powerful software at the coordinating centerincluding: intelligent character recognition from faxedCRFs, query tracking, standard reports, audit trails,study setup tool, bookmarked PDFs of patient CRFs,acceptance test kit, and much more.



Clinsoft CorporationClintrial, Clintrial Connect, Clintrace See Trials Management/Administration


CRF BoxCRF Box Wireless See Electronic Data Capture (EDC)

DataCeutics, Inc.Clinical Information Technology Consulting See ITConsulting


Datapharm Australia Pty. Ltd.eCRF See Electronic Data Capture (EDC)




DZS Software Solutions, Inc. 1661 Route 22West, Bound Brook, NJ 08805, USA, (732) 764-6969,fax (732) 764-6755, e-mail: [email protected],www.clinplus.com

ClinPlus Data Management DZS Software Solutions is theleader in SAS-based software solutions for clinical datamanagement and reporting. The ClinPlus family ofproducts enables your company to meet its goals in atimely and cost-effective manner.


ETRAC Solutions, Inc.Project Management Solutions See Clinical ProjectManagement


Fortress Medical Systems, Inc 310 7thAve., North Hopkins, MN 55343, USA, (952) 988-9123,e-mail: [email protected], www.fortressmedical.com

Clindex 2.0 Clindex is in an easy-to-use Windows-basedpackage allowing clinical trials staff to plan and create


imaging, and Web components. Study setup wizards,automated forms tracking, CRF images received fromscan, fax, or file links directly to data for view through-out system. Completely operational within 30 days.Easily customizable by client.

ClinAccess SureStart Validated SAS-powered clinical datamanagement software with study set-up wizards, doublekey entry, validation, audit trails, point-and-click statisti-cal tools, option for dictionary autoencoder (for adverseevents, etc.). Designed as entry-level clinical datamanagement system, completely upgradeable toPowerServer. Operational within 30 days. Easilycustomizable by client.

ClinAccess Web Component Enter data and resolvequeries using the Internet. When combined with otherClinAccess modules, supports studies in which eachinvestigator can choose between paper CRFs, fax, orWeb CRFs, while entering all data into a single SASdatabase. Call for availability.






RegistryExpert RegistryExpert allows users to link andtrack products, patients, care facilities, capital equip-ment, medical professionals, and more. Register andtrack capital equipment and products by productnumber, serial/lot number, date, or your own system.Features multiple address capability to quickly locatepatients with products in critical situations.



TrackExpert TrackExpert offers a centralized, easy-to-usemethod for tracking your inventory from the factory todelivery to the patient. The software is designed to meetthe regulations for implantable devices as specified by21 CFR 821.


OmniComm Systems, Inc. 3250 Mary St.,Ste. 402, Coconut Grove, FL 33133, USA, (305) 448-4700, fax (305) 448-4757, e-mail: [email protected], www.omnicomm.com

TrialMaster OmniComm Systems provides Web-baseddata capture applications for the clinical trial industry.Our applications include electronic CRFs, subject enroll-ment tracking, randomization, e-mail communication,and a robust enterprise manager designed for trialbudget, payment information, site(s) overview, andmore.

PerMedics, Inc.Surveyor See Trials Management/Administration


PHT CorporationEsendant Clinical Network See Electronic Data Capture(EDC)

PPD Informatics 84 Sherman St., Cambridge, MA02140, USA, (617) 868-6878, fax (617) 868-2654, e-mail: [email protected], www.ppdinformatics.com

TableTrans TableTrans helps specify complex data trans-formations by using Oracle as a powerful data transfor-mation engine. You can execute transformations interac-tively or generate SQL scripts for batch execution.Applications of TableTrans include migrating legacydatabases, validating/cleaning data, creating analysisviews of a database, extracting data for analysis.




SAM GmbHars RDE system See Electronic Data Capture (EDC)

Skila, Inc.iKnow—New Product Launch See Knowledge Management

iWorksite See Knowledge Management


SyMetric Sciences, Inc. 1-2082 SherbrookeWest, Montreal, QC H3H 1G5, Canada, (514) 935-4562, fax (514) 935-9911, e-mail: [email protected],www.symetric.ca

SyMetric Clinical Data Management system Comprehen-sive data management system for clinical trials includ-ing full support for double data entry, multivariate datavalidation, data dictionary, autoencoders for all standarddictionaries (ICD9, MedDRA, WHO, etc.), query manage-ment, flexible export to ASCII, HTML, and SAS, etc.Complies with all regulatory requirements. For moreinformation, please visit our Web site.

SynteractSynCoder See Adverse Events

TEAMworks Clinical ServicesTRIALink EDC Systems See Electronic Data Capture(EDC)




Spirotrac Centralized Spirometry System See ElectronicData Capture (EDC)

Winchester Business Systems, Inc.paraFILE See Document Management

Zurich Biostatistics, Inc. 45 Park Place South,PMB 178, Morristown, NJ 07960, USA, (973) 727-0025or (973) 727-0024, e-mail: [email protected],www.zbi.net

Tekoa XML Technology Tekoa XML Technology brings XMLinto the SAS world. Import, process, and export XMLusing 100% nonexperimental base SAS tools in a waythat feels natural to SAS users unfamiliar with XML. TheCDISC XML ODM clinical data model is fully supported.

Data Mining andVisualization



















iBiomaticsPH.Dataware See Data Warehousing


invivodata, inc.invivosystem See Data Collection/Management





ClinAccess Dictionary Coder See Data Collection/

Management










ReportExpert Deliver sophisticated analytical reportsfrom one or many databases using ReportExpert’sintuitive Web-based interface. Allows you to createunlimited ad hoc reports or drill down into importantdata using a library of predefined reports. Featuresautomated reporting and e-mail generation as well asthe ability to export data to popular applications.












Synergy Software 2457 Perkiomen Ave.,Reading, PA 19606, USA, (610) 779-0522 or (800)876-8376, fax (610) 370-0548, e-mail: [email protected], www.synergy.com

KaleidaGraph KaleidaGraph transforms your complexdata into meaningful 2D graphs! Data can be entered orimported from an Excel or text file with a flexible importfacility. Use algebraic and statistical functions to manip-ulate billions of data points. Graph 20 variables withprecise control of plot elements. Powerful curve-fitting.



Data WarehousingAcumen Healthcare Solutions, LLCTracIt2k EDC System See Electronic Data Capture (EDC)




















iBiomatics 11000 Weston Parkway, Ste. 110, Cary,NC 27513, USA, (919) 653-2700, fax (919) 653-2701,e-mail: [email protected], www.ibiomatics.com

G23 Genomics Knowledge Platform The G23 GenomicsKnowledge Platform integrates data from genomicinstrumentation systems and other sources, and thendelivers standardized data via the Internet toresearchers’ desktops. Instead of spending their timerestructuring data, scientists can begin their analysesimmediately, enabling them to find potential targetsfaster.

P21 Biomedical Knowledge Platform P21 consolidatesdisparate data and documents into a validated, Web-based collaborative environment. Professionals in R&D,biometrics, regulatory affairs, and QA can explorebiomedical data when they want to, how they want to.Because of its open architecture, you can use existinganalysis tools and applications within the platform.

PH.Clinical PH.Clinical provides researchers with a clini-cal data exploration and reporting system for generatingstandard or ad hoc tables, listings, and analysis output.

PH.Dataware PH.DataWare allows researchers tomanage clinical trials data from a variety of sources in aclinical data warehouse.











http://lifesciences.fcg.com

FirstDocs for CRFs FCG has combined the industry’sbest practices, state-of-the-art technology, and consult-ing services to produce FirstDocs for CRFs, the indus-try’s only Documentum-based, prepackaged electronicdocument management solution for case report forms(CRFs). Our solution addresses highly complexdocument management requirements associated withCRFs.



iBiomaticsG23 Genomics Knowledge Platform See Data Ware-housing

P21 Biomedical Knowledge Platform See Data Ware-housing

idv Data Analysis & Study PlanningICH-Study-Report-Manager See Clinical Project Management


IntraLinks, Inc.IntraLinks digital workspaces See Web-Based SoftwareServices























DocumentManagement

Adapt~EDC, LLCAdapt~EDC Clinical Trials Suite See Data Collection/Management




CDC Solutions Inc.EZsubs See Electronic Submissions



Document Control Systems, Inc. 6322South 3000 East, Ste. 300, Salt Lake City, UT 84121,USA, (800) 825-9117, fax (801) 942-7088, e-mail:[email protected], www.mastercontrol.com

MASTERControl FDA Edition Validation-ready documentcontrol software that addresses electronic signatures/electronic record management and document securityrequirements of 21 CFR 11 and FDA CGMP. Thisincludes both the enhanced features needed to complywith those standards and assistance with validation.Software has been used by FDA companies since early1998.


First Consulting Group 575 E. Swedesford Rd.,Ste. 200, Wayne, PA 19087, USA, (610) 989-7000, fax(610) 989-7100, e-mail: [email protected],

















QUMAS Inc. 325 Columbia Turnpike, FlorhamPark, NJ 07932, USA, (973) 377-8750 or +353 21 4320050, fax (973) 377-8687, e-mail: [email protected],www.qumas.com

CAPAcompliance QUMAS provides enterprise compliancemanagement solutions for regulated companies.QUMAS solutions allow companies to effectively secure,manage, and distribute regulatory information in compli-ance with the latest FDA and international regulations,including 21 CFR 11. QUMAS solutions are finishedapplications and are delivered with validation, training,and rapid-deployment services.

DocCompliance QUMAS provides enterprise compliancemanagement solutions for regulated companies.QUMAS solutions allow companies to effectively secure,manage, and distribute regulatory information in compli-ance with the latest FDA and international regulations,including 21 CFR 11. QUMAS solutions are finishedapplications and are delivered with validation, training,and rapid-deployment services.

e-DocCompliance QUMAS provides enterprise compli-ance management solutions for regulated companies.QUMAS solutions allow companies to effectively secure,manage, and distribute regulatory information in compli-ance with the latest FDA and international regulations,including 21 CFR 11. QUMAS solutions are finishedapplications and are delivered with validation, training,and rapid-deployment services.








Health Agency Tracking The Health Agency Trackingsystem tracks documents associated with queries andresponses made by and to regulatory agencies.Automatic workflow notifies all project team membersand initiates action items for resolution of the query.Maintains complete audit trail. Conforms to 21 CFR 11regulations for electonic records and signatures.

paraFILE paraFILE helps users capture, author, edit,

review, approve, distribute, retrieve, and manageelectronic documents globally—documents from anycomputer source or application. Document creation,review, and approval is done collaboratively. ManageNDAs, submissions, SOPs, protocols, etc. Exceedsrequirements for electronic signatures and records asrequired by 21 CFR 11 regulation.




Electronic DataCapture (EDC)

Acumen Healthcare Solutions, LLC 1425223rd Ave. North, Plymouth, MN 55447, USA, (763) 559-8232 ext. 24, fax (765) 559-2821, e-mail: [email protected], www.acumenhealthcare.com

TracIt2k EDC System TracIt2k is a fully automated, off-line EDC system that cleanses and validates all dataprior to transmission to a sponsor. The system alsoautomatically maps and uploads to any ODBC database.Acumen also provides Web-based EDC and wirelesstechnology. To speed up and reduce the cost of trials,use TracIt2k.


Araccel Corporation 120 Gibraltar Rd., Ste.106, Horsham, PA 19044, USA, (919) 674-8174, fax(919) 674-8146, e-mail: [email protected],www.araccel.com

Araccel Solutions Platform Araccel Corporation is abiomedical information technology company thatprovides integrated enabling technology solutions to thepharmaceutical industry. Araccel develops and marketse-R&D pharmaceutical software and system solutionsthat capture and clean clinical data, improve processesand provide metric reports on clinical trial data forenhancing and accelerating drug development.





Cardinal systems 91 avenue de la République,75011 Paris, France, +33 1 40 21 19 07, fax +33 1 4021 94 95, e-mail: [email protected], www.cardinal-sys.com

CRFSuite and DBMSuite Five years of expertise in regula-tory biometry and technology management (e.g., IVRSand Internet combined) constitutes Cardinal systems’guarantee to manage your clinical data in the mostsecure way. Cardinal systems’ Internet applicationsDBMSuite and CRFSuite are dedicated to CRF design,investigator data entry, monitoring, data management,and safety reporting.

CB Technologies, Inc. 350 Eagleview Blvd.,Exton, PA 19341-1155, USA, (610) 280-7400, fax (610)280-0440, e-mail: [email protected], www.cbtech.com

MetaTrial CB Technologies is the premier provider oftechnology tools and services to the life science indus-tries. CB’s solutions include MetaTrial clinical electronicdata capture software and myMetaTrial ManagementPortal. These innovative solutions enable greaterefficiencies in the clinical trials process. For moreMetaTrial information, visit www.metatrial.com.


Clinical DataFax Systems Inc.DataFax See Data Collection/Management




CompleWare Corporation PO Box 3090, IowaCity, IA 52244, USA, (319) 338-8888 or (800) 369-8888, fax (319) 338-1604, e-mail: [email protected], www.compleware.com

WebCRF WebCRF allows for the complete integration ofcase report form (CRF), diary, laboratory, ECG, andspirometry data. Data is available online, 24 hours aday, 7 days a week, increasing monitoring capabilitiesand allowing clinical trials to be completed much morerapidly than with other data collection methods.

CRF Box Central Europe Vinohradska 184,13052 Prague 3, Czech Republic, +420 2 6713 2764or +420 602 669 062, fax +420 2 6713 2765, e-mail:[email protected], www.crfbox.com

CRF Box Ltd.—HeadquartersTammasaarenkatu 5, 180 Helsinki, Finland, +358 201700 70 or +358 201 700 740, fax +358 201 700 710,e-mail: [email protected], www.crfbox.com

CRF Box Scandinavia Hammarby Fabriksväg 23,12033 Stockholm, Sweden, +46 8 643 4270 or +35840 560 8189, fax +46 8 5560 9340, e-mail: [email protected], www.crfbox.com

CRF Box U.S. 124 Mt. Auburn St., Ste. 20026,North Cambridge, MA 02138, USA, (617) 520-6609 or(617) 494-5590, fax (617) 494-5589, e-mail: [email protected], www.crfbox.com

CRF Box Wireless CRF Box Wireless is the first electronicsubject diary solution utilizing multiple platform tech-nology. This allows multiple end-terminals, high datasecurity, and flexible integration to existing IT infrastruc-ture. The technology accelerates trial completion,encourages protocol compliance, and enhances thera-peutic claims, allowing communication of a drug’s valueto the medical marketplace.


Datapharm Australia Pty. Ltd. 56-56AThompson St., Drummoyne, NSW 2047, Australia, +612 9719 2800, fax +61 2 9719 2811, e-mail: [email protected], www.datapharm.com.au

eCRF eCRF is a remote data capture tool allowing sitesto send clinical trial data electronically to Datapharm’ssecure server. Fields are programmed with edit checksand database lookups allowing quick access to cleandata that can be viewed on the Web. System setup andmaintenance is cost-effective.


Datasential LLC 440 Getty Ave., Clifton, NJ07011, USA, (866) 840-2202 or (201) 655-5005, fax(973) 478-0037, e-mail: [email protected],www.datasential.com

TrialOne Services TrialOne is a turn-key, Web-based,outsourced solution for gathering clinical trial data.Providing solutions for investigator sites, subject diarydata, and lab reports. Offering features and functionalitynot found anywhere else in the EDC marketplace.Realize the full potential of EDC with TrialOne byDatasential.

DATATRAK Deutschland, GmbH AmPropsthof 80, 53121 Bonn, Germany, +49 228 9798330, fax +49 228 979 8334, e-mail: [email protected], www.datatraknet.com

DATATRAK International, Inc. 20600Chagrin Blvd., Ste. 1050, Cleveland, OH 44122, USA,(216) 921-6505, fax (216) 921-6702, e-mail: [email protected], www.datatraknet.com

DATATRAK EDC DATATRAK International, Inc., with officesin Cleveland, OH, and Bonn, Germany, specializes inelectronic data capture using DATATRAK EDC. Theproduct suite operates in centralized or stand-alonemodes, and offers state-of-the-art security and real-timedata entry and review. Electronic site-assessment, Web-based training offered.

Dendrite International, Inc. 1200 Mt. KembleAve., Morristown, NJ 07960-6797, USA, (732) 246-


8518 or (973) 615-9369, fax (732) 745-8737, e-mail:[email protected], www.dendrite.com

eClinical Global Deployment Facilitators Dendrite is a soft-ware and hardware independent facilitator of e-clinicalprogram implementation for hardware deployment, helpdesk, Web-based training, IVRS voice recognition forsubject randomization and diaries and short CRF dataentry, adverse event management and reporting, siteand subject recruitment, to save time and cost tomarket.

Document Control Systems, Inc.MASTERControl FDA Edition See Document Management

eResearchTechnology, Inc. 1150 Route 22,East Bridgewater, NJ 08807, USA, (908) 704-8010,(908) 704-8010 ext. 134, fax (908) 541-0091, e-mail:[email protected], www.ert.com

eResearch Network and Community TechnologieseResearchTechnology, Inc. (eRT) is a provider ofintegrated Web-based technology products and servicesto the biotechnology, pharmaceutical, and medicaldevice industries. eRT can streamline the conduct of astudy by transforming it from a manual paper-basedsystem to an electronic process of data collection,analysis, and reporting. eRT also provides centralizedcollection and interpretation of electrogradiographicinformation.


FW Pharma SystemsINITIATOR See Trials Management/Administration

Health Care Online, Inc. PO Box 6524, Annapolis, MD 21401, USA, (410) 897-9509 or (410)897-9080, fax (410) 510-1984, e-mail: [email protected],www.hcol.com

HCOL Clinical Study Enterprise Edition HCOL ClinicalStudy Enterprise Edition takes advantage of the efficien-cies of the Web, wireless, PDAs, and touch-screen PCsto accelerate the capture of clinical data. Our systemallows both clinicians and subjects to enter dataanywhere. Studies can be monitored remotely in real-time and managed cost-effectively.


InferMed Limited 23 Bedford Square, LondonWC1B 3HH, UK, +44 20 7269 3708 or +44 20 72693708, fax +44 20 7269 3716, e-mail: [email protected], www.infermed.com

MACRO MACRO is an application based on core propri-etary technology. It is a modular system for runningInternet-based multicenter trials. MACRO’s intuitive,interactive tools for remote study definition, online andoff-line remote data entry, and remote study monitoringreduce set-up time and improve time to databaseclosure.




LifeTree Technology, LLC 41093 CountyCenter Dr., Temecula, CA 92591, USA, (800) 843-7477,fax (800) 418-4333, e-mail: [email protected],www.lifetree-tech.com

LifeTree ICTM LifeTree ICTM is a comprehensive Internet-based solution that accelerates trials, setting thestandard for trial data management. ICTM’s Web-basedsystem simplifies study design and data management,automates electronic case report forms (eCRFs) andaccelerates data entry and validation. ICTM answers thedemand for exceptional data management.

Logos Technologies Ltd. Chiltern House, Feath-ers Yard, Basingstoke, Hampshire RG21 7AT, UK, +441256 478900, fax +44 1256 473332, e-mail: [email protected], www.logostechnologies.com

ALPHADAS We are an international company leading theway in EDC from clinical trials. Our product ALPHADASuses smartcards in order to comply with GCP and FDA21 CFR 11 on the archival of source data. ALPHADAScan be used across all areas of clinical research forremote or direct data collection.

SMART Patient Diary Card We are an internationalcompany leading the way in EDC from clinical trials. Ourproduct ALPHADAS uses smartcards in order to complywith GCP and FDA 21 CFR 11 on the archival of sourcedata. ALPHADAS can be used across all areas of clinicalresearch for remote or direct data collection.








ActivityExpert ActivityExpert is an entirely Web-basedsolution that enables any authorized person to inputinformation into NetRegulus’ PQIntelligence SoftwareSystem. It is ideal for vendors, field representatives,auditors, clinical trial personnel, and others who requirelimited access to the system’s functionality. User train-ing is not required for this Web-based module.








Phase Forward Incorporated 1440 Main St.,Waltham, MA 02451, USA, (888) 703-1122 or (781)890-7878, fax (781) 890-4848, e-mail: [email protected], www.phaseforward.com

InForm Phase Forward’s InForm provides the firstcompletely integrated clinical data management solutionthat leverages the power of the Internet to acceleratethe clinical trial process and helps to ensure rapiddatabase lock and facilitate FDA approval. Using anyWeb browser, InForm offers security and scalability withminimal training efforts.

PHT Corporation 500 Rutherford Ave.,Charlestown, MA 02129, USA, (617) 973-1600, fax(617) 973-1601, e-mail: [email protected],www.phtcorp.com

Esendant Clinical Network Esendant Clinical Networkcollects, processes, and archives data used in develop-ment, approval, and marketing of pharmaceuticals.Unique Web EDC system architecture based on XML-based open data model consistent with CDISCstandards, yielding easy integration with legacy systemsplus ready system expansion. Palm-based LogPadsubject diary offers true e-source.


SAM GmbH Huettenstr. 7, D-52068 Aachen, NRW,Germany, +49 241 8882103 or +32 87 789120, fax+49 241 8882100, e-mail: [email protected],www.SAM-Germany.de

ars RDE system Windows NT and 2000–based, unlimitednumber of checks/crosschecks. ars meets all FDA RDErequirements; ars monitoring modules support sourcedata verification, modem-based transfer of data,automatically PGP-coded, from trial centers via RDEserver to monitors, drug safety, DM/biometric depart-ments, interfaces to electronic (e.g., blood pressure)devices.

StudyBuilder B.V. Postbus 177, 1000 ADAmsterdam, The Netherlands, +31 71 514 2988, fax+31 71 514 2986, e-mail: [email protected],www.studybuilder.com

StudyBuilder Enterprise Edition StudyBuilder EnterpriseEdition ($4999/study designer; no site/subject/datamanager fees) integrated study design, data manage-ment and collection package. Use wizards and drag-and-drop to design and deploy your study. Includes datacollection/management system for Web, palmtop, anddesktop computers and integrates data from spirome-ters, etc., automatically.

TEAMworks Clinical Services 1 Farnham Rd.,Guildford, Surrey GU2 5RG, UK, +44 1483 549 019, fax+44 1483 549 119, e-mail: [email protected],www.teamworks.de

TRIALink EDC Systems TEAMworks was founded in 1997following successful introduction of our Internet-basedTRIALink electronic data capture (EDC) system. TheTEAMworks organization has since established itself asa leading EDC innovator and vendor with experience inthe implementation, deployment, and support of e-clini-cal trials across all phases and international geogra-phies. With offices in Switzerland, the UK, Germany,Singapore, and USA, TEAMworks is also establishingitself as a global leader in applying innovative Internettechnologies together with high performance processesto automate the clinical trial process.


Vitalograph Ltd. Maids Moreton, Buckingham,Buckinghamshire MK18 1SW, UK, +44 1280 827120 or+44 1280 827107, fax +44 1280 823302, e-mail:[email protected], www.vitalograph.co.uk

Electronic PEF/FEV1 Diary Vitalograph has been a worldleader in respiratory diagnostics for almost 40 years.The Centralized Spirometry System transmits encrypteddata every day via e-mail from investigator sites direct tothe sponsor or via a dedicated and unique over-readsoftware system where data quality is ensured on adaily basis.

Spirotrac Centralized Spirometry System Vitalograph hasbeen a world leader in respiratory diagnostics for almost40 years. The first of its kind, this PC Spirometrysystem enables investigators to click on an e-mailbutton to transmit encrypted data over the Internet.Optional and unique over-reading software ensures high-quality data on a daily basis.

Winchester Business Systems, Inc.adWatch See Adverse Events





Zurich Biostatistics, Inc.Tekoa XML Technology See Data Collection/Management

ElectronicSubmissions



Cardiff Software, Inc. 3220 Executive RidgeDr., Vista, CA 92083, USA, (760) 936-4500, fax (760)936-4800, e-mail: [email protected], www.cardiff.com

LiquidOffice The LiquidOffice eForm ManagementSystem is a complete XML-based solution that is usedto automate forms and the business processes theydrive. LiquidOffice uses XML, HTML, and Adobe PDFstandards to put forms into an online system—complete with routing, online approval, digital signa-tures, and data processing.

Cardinal systemsCRFSuite and DBMSuite See Electronic Data Capture (EDC)

CDC Solutions Inc. 6 Tower Bridge, Ste. 440,181 Washington St., Conshohocken, PA 19428, USA,(610) 834-9021 or (610) 834-4212, fax (610) 834-9023, e-mail: [email protected], www.cdcsolutions.com


EZsubs EZsubs from CDC Solutions provides unparal-leled document assembly, delivery, and publishingsolutions for the process of publishing complex regula-tory documents and submissions. EZsubs is a highlyscalable publishing solution capable of handling submis-sions to regulatory agencies, ranging in size from smallBiologics License Applications (BLAs) to New Drug Appli-cations (NDAs).






iBiomaticsP21 Biomedical Knowledge Platform See Data Ware-housing

























IT ConsultingAraccel CorporationAraccel Solutions Platform See Electronic Data Capture(EDC)





DataCeutics, Inc. 1610 Medical Dr., Ste. 300,Pottstown, PA 19464, USA, (610) 970-2333 or (610)970-4050, fax (610) 970-4884, e-mail: [email protected], www.dataceutics.com

Clinical Information Technology Consulting DataCeutics isthe leader in clinical information technology support andservices for clinical, data management, and biostatisti-cal teams. Primary services are clinical data manage-ment and clinical reporting consulting, electronicsubmission support, ASP service, migration, outsourc-ing, validation, and 21 CFR 11 compliance.




Intrasphere Technologies, Inc. 100 Broad-way, 10th Floor, New York, NY 10005, USA, (212) 937-8200, email: [email protected], www.intrasphere.com

Systems Integration Intrasphere Technologies providestechnology consulting and systems integration for EDC,clinical trials management, safety and pharmcovigi-lance, e-intelligence, document management, corporatefinance, and enterprise information portals.






SEC Associates, Inc.Computer system compliance consulting See Validation










KnowledgeManagement

Authentica, Inc. 170 Tracer Lane, Waltham, MA02451, USA, (781) 487-2600, fax (781) 290-0424, e-mail: [email protected], www.authentica.com

MailRecall, PageRecall, NetRecall Authentica, Inc.provides information security software that letsbusinesses and organizations protect intellectualproperty and sensitive information throughout theirlifecycle. With Authentica, users can dynamically controland manage their recipients’ use rights to informationincluding the rights to view, print, copy, and forwardinformation.

BBK Healthcare, Inc. 320 Needham St., Ste.150, Newton, MA 02464, USA, (617) 630-4477, fax(617) 630-5090, e-mail: [email protected],www.bbkhealthcare.com

TrialCentral.net With TrialCentral.net, BBK connects clini-cal teams, regulatory groups, investigators, and theirstaffs, outsource suppliers, and study participants in a“virtual community,” improving operational efficiency andultimately accomplishing trial recruitment and retentiongoals. The application is compatible with the wide rangeof telemanagement and EDC systems currently in themarketplace.

Biostat, Inc.Comprehensive Meta Analysis See Statistical Analysis


CDC Solutions Inc.EZsubs See Electronic Submissions








PH.Clinical See Data Warehousing

PH.Dataware See Data Warehousing







PQIntelligence PQIntelligence is the smart, 21 CFR11–compliant software system that provides enterprise-wide, Web-enabled data management specifically for themedical products industry. Working in the background,PQIntelligence organizes, automates, and manages clinical, regulatory, and other product data, while youfocus on what you do best: developing and marketingyour product.





Skila, Inc. 1200 MacArthur Blvd., Mahwah, NJ07430, USA, (888) 887-5452 or (201) 818-2277, fax(201) 818-5222, e-mail: [email protected], www.skila.com

iKnow—New Product Launch Skila’s integrated newproduct launch Web-based knowledge solution enablesglobal product launch teams “to know,” “exchangeknowledge,” and “take action” with internal (from clini-cal and manufacturing to marketing and sales) andexternal stakeholders to shorten time to market,increase the uptake curve, and increase revenues fornew products.


iWorksite Skila’s Web-based global business intelligencesolution redefines how health care intelligencedecisions are made through decision-enabling applica-tions, market-based intelligence, and connectivity.Skila’s Intelligration technology synthesizes and trans-forms thousands of sources into succinct views ofactionable business intelligence for smarter and moreconfident decisions.


Valid Systems Incorporated 800 WestCummings Park, Ste. 6800, Woburn, MA 01801, USA,(781) 756-6200 or (781) 756-6226, fax (781) 756-6220, e-mail: [email protected], www.validsys.com

Records Manager for Lotus Notes Mail The Valid RecordManager for Lotus Notes Mail is a complete solution forproviding electronic recordkeeping to your e-mail. Theproduct uses a folder-based interface for acceptingrecords from e-mail, and then provides record classifica-tion and record lifecycle management. No modificationsof the mail template are required.









Medical ImagingAdapt~EDC, LLCAdapt~EDC Clinical Trials Suite See Data Collection/Management


Statistical AnalysisAcumen Healthcare Solutions, LLCTracIt2k EDC System See Electronic Data Capture (EDC)


Analyse-it Software, Ltd. PO Box 77, LeedsLS12 5XA, UK, +44 113 229 5599, fax +44 113 2632101, e-mail: [email protected], www.analyse-it.com

Analyse-it Clinical Laboratory Analyse-it! Method valida-tion and evaluation software for Microsoft Excel.Includes NCCLS and IFCC protocols, Altman-Bland andNCCLS bias plots, Deming, Passing-Bablok, and Kappamethod comparisons, NCCLS EP5imprecision, NCCLSEP6 linearity, IFCC reference ranges, ROC curves, andsensitivity and specificity analysis. Visit our web site todownload a free trial.


Biostat, Inc. 14 North Dean St., Englewood, NJ07631, USA, (201) 541-5688, fax (201) 541-5526, e-mail: [email protected], www.Meta-Analysis.com

Comprehensive Meta Analysis Comprehensive MetaAnalysis is a computer program for meta-analysis thatcombines ease of use with a wide array of computa-tional options and sophisticated graphics.

Power And Precision Power and Precision is a computerprogram for power analysis, to find the sample sizerequired for a planned study. Work with confidence. Getthe big picture in seconds. Present your results profes-sionally.





ClinPlus Coding See Web-Based Software Services

ClinPlus Data Management See Data Collection/Management

ClinPlus NDA Systems supported: Unix, Windows 95/NT,and SAS platform. DZS Software Solutions is the leaderin SAS-based software solutions for clinical datamanagement and reporting. The ClinPlus family ofproducts enables your company to meet its goals in atimely and cost-effective manner.

ClinPlus Remote See Web-Based Software Services

ClinPlus Report DZS Software Solutions is the leader inSAS-based software solutions for clinical data manage-ment and reporting. The ClinPlus family of productsenables your company to meet its goals in a timely andcost-effective manner.

GraphPad Software, Inc. 5755 Oberlin Dr.,Ste. 110, San Diego, CA 92028, USA, (858) 457-3909,fax (858) 457-8141, e-mail: [email protected],www.graphpad.com

InStat InStat (Windows/Macintosh) conquers routinestatistics by escorting you through analyses step bystep. You’ll master the program in minutes—really.InStat is designed for analyzing small amounts of data,and is a perfect companion to more complex programs.Download a free InStat demo at www.graphpad.com.

Prism GraphPad Prism (Windows/Macintosh) combinesbiostatistics, curve fitting, and graphing in one compre-hensive program. Prism’s unique design helps efficientlyanalyze, graph, and organize experimental data. Prismhelps you choose the right test and interpret theresults. Download a free Prism demo at www.graphpad.com.


iBiomaticsPH.Clinical See Data Warehousing

idv Data Analysis & Study Planning Wesso-brunner Str. 6, 82131 Gauting/Munich, Germany, +4989 8508001, fax +49 89 8503666, e-mail: [email protected].

N Systems supported: Windows 95/98/2000/NT/ME.N: planning and interpreting sample sizes. Event data(binomial test) or quantitative data (t-test). Target:sample size, beta, alpha, smallest detectable differ-ence. Test for difference and equivalence/noninferiority.One sample and a constant, two correlated samples,parallel-group design, two-period crossover.

Nnpar 1.0 Systems supported: Windows 95/98/2000/NT/ME. Nnpar 1.0: planning and interpretation ofstudies concerning samples within the framework of theWilcoxon-Mann-Whitney test. Target parameters: samplesize, alpha, beta, and smallest detectable differenceexpressed as Mann-Whitney statistic P (X<Y) + 0.5 P(X=Y).

Nsurv Systems supported: Windows 95/98/2000/NT/ME. Nsurv: planning and interpreting of sample size. Fortime-to-occurrence data. Target parameters: samplesize, beta, alpha, smallest detectable difference. Testfor difference and equivalence/noninferiority. Differenceor quotient, lambda (hazard), median, mean, proportion.Various group size ratios: balanced and unbalanced.

Rancode Prof. Systems supported: Windows 95/98/2000/NT/ME. Rancode Prof.: randomizing trialsubjects. It prepares random code lists, sealedenvelopes, and stick-on labels. Rancode Professionalcomes with many facilities for working in a validatedenvironment according to GCP and FDA regulations.GCP-compliant automatic decoding.

SmarTest Systems supported: Windows 95/98/2000/NT/ME. SmarTest: nonparametric multivariate analysisof multiple endpoints and repeated measures followingthe procedure of Wei and Lachin (1984): multivariategeneralization of Wilcoxon-and-Logrank tests; two-groupcomparisons. Test for difference and equivalence/non-inferiority, tests and confidence intervals.

TESTIMATE 6.0 Systems supported: Windows 95/98/2000/NT/ME. TESTIMATE 6.0 offers exact tests basedon a number of permutational algorithm and classicalprocedures. Descriptive statistics, ROC, ANOVA/ANCOVA, and two-period crossover (bioequivalence),medical diagnostics, and nonparametric tests. P-valuesand confidence intervals, test for equivalence/non-inferiority.


Insightful Corporation 1700 Westlake Ave.North, Ste. 500, Seattle, WA 98109, USA, (206) 283-8802 or (800) 569-0123, fax (206) 283-8691, e-mail:[email protected], www.insightful.com

S-PLUS and SeqTrial, Server Products Insightful Corpora-tion provides software and services for statistics,predictive modeling, and data mining. Our productsinclude S-PLUS, StatServer, and S-PLUS Analytic Server.Our data analytics help thousands of people understandreality and anticipate the future. Insightful’s consultingservices provide modeling and development for CRMand business intelligence using Web-based analytics.














PPD InformaticsCrossGraphs See Other Applications


Resampling Stats, Inc. 612 N. Jackson St.,Arlington, VA 22201, USA, (703) 522-2713, fax (703)522-5846, e-mail: [email protected], www.resample.com

Resampling Stats Software Resampling Stats uses thenew statistics of resampling (including bootstrappingand permutation). Resampling is excellent for confi-dence intervals, hypothesis tests, and assessing errorsin estimates used to determine reliability of conclusionsdrawn from small samples. Resampling Stats’ easy-to-use programming language lets you design resamplingprocedures with your data.

Research Triangle Institute/SUDAAN 3040Cornwallis Rd., PO Box 12194, Research Triangle Park,NC 27709-2194, USA, (919) 541-6602, fax (919) 541-7431, e-mail: [email protected], www.rti.org/sudaan

SUDAAN SUDAAN is designed for analysis of cluster-correlated data from studies involving longitudinal data,repeated measures, or multi-stage sample designs.SUDAAN fits marginal or population-averaged modelsusing generalized estimating equations (GEE). Robustvariance estimates are computed, which fully accountfor intracluster correlation, unequal weighting, stratifica-tion, and without-replacement sampling.

Stat-Ease, Inc. 2021 E. Hennepin Ave., Ste. 191,Minneapolis, MN 55413, USA, (612) 378-9449, fax


(612) 378-2152, e-mail: [email protected],www.statease.com

Design-Ease Software Design-Ease software sets up andanalyzes powerful general and two-level factorials thatidentify the critical factors for improvement of productsand processes.

Design-Expert Software Used for the design and analysisof two-level and general factorial screening experiments.Offers response surface methods for optimizingprocesses and/or mixtures. Design-Expert produces 3Drotatable graphs and offers numerical search capabilityto find the sweet spot for any number of responses thatmust meet specifications.

Synergy SoftwareKaleidaGraph See Data Mining and Visualization

Zurich Biostatistics, Inc. 45 Park Place South,PMB 178, Morristown, NJ 07960, USA, (973) 727-0025or (973) 727-0024, e-mail: [email protected],www.zbi.net

Tekoa XML Automation Technology Tekoa XML AutomationTechnology retires the DATA _NULL_ and SAS reportingprocedures and replaces them with an automated, XML-based reporting system that integrates seamlessly withSAS-based statistical analysis. Statisticians programless, do statistics more.

TrainingDataCeutics, Inc.Clinical Information Technology Consulting See ITConsulting


DZS Software Solutions, Inc.ClinPlus NDA See Statistical Analysis




idv Data Analysis & Study PlanningN See Statistical Analysis

Nnpar 1.0 See Statistical Analysis

Nsurv See Statistical Analysis

TESTIMATE 6.0 See Statistical Analysis






NetRegulusIssueExpert See Adverse Events






SEC Associates, Inc.Computer system compliance consulting See Validation

Stat-Ease, Inc.Design-Ease Software See Statistical Analysis

Design-Expert Software See Statistical Analysis




Invantage, Inc. 201 Broadway #601, Cambridge,MA 02139, USA, (617) 577-7844, fax (617) 249-0844,e-mail: [email protected], www.invantage.com

Investigator DataWeb System Invantage’s InvestigatorDataweb is a unified Web-based repository and decisionsupport environment for corporate-wide collaborationand proprietary knowledge management regarding largenumbers of potential investigators. Using a personalizedWeb interface, sponsors access and analyze potentialinvestigator data, producing highly informed and confi-dent decisions regarding effective trial placement.









StudyExpert StudyExpert streamlines the managementof clinical trial and other study data while complying withclinical trial computer systems and 21 CFR 11. Featuresintuitive tools to enter, track, verify, query, view, andexport case report form data as well as input andoversee key management information.




PerMedics, Inc. 1475 S. Victoria Court, SanBernardino, CA 92408, USA, (877) 4PERMED, fax (909)478-5016, e-mail: [email protected], www.permedics.com

Surveyor Surveyor is a breakthrough software applica-tion designed specifically for site-level clinical trialsmanagement. Surveyor provides clinical research profes-sionals with tools for tracking subjects and studies,including scheduling, budgeting, screening, and report-ing tools. The client-server, Web-enabled software offersdata partitioning and high-level security features,making study management simple and cost-efficient.


ProIRB Plus, Inc. 6020 44th Ave. N., St. Peters-burg, FL 33709, USA, (727) 545-5314, fax (727) 541-2433, e-mail: [email protected], proirb.com

PRO_IRB PRO_IRB is a multi-user, multi-IRB softwareapplication providing productivity and compliance assur-ance tools for managing the institutional review boardworkflow process from scheduling to meeting minutes.The application is developed in MS Access and iscurrently in use by major universities and health careinstitutions nationwide.

Propack Data Corp. 2000 Regency Parkway, Ste.375, Cary, NC 27511, USA, (919) 465-1741, fax (919)465-1742, e-mail: [email protected],www.propack-data.com

PMX CTM Solution The CTM solution fulfills the specificrequirements of the pharmaceutical industry. CTMstands for the organization of the complete material andinformation flow: the production of the substances,randomization, and packaging to the delivery, batchtracing, and surveillance of the expiry and retest date ofthe trial samples at the clinical centers.


Validation Wizards InternationalValidation Wizard for Application User Teams See Validation

Trials Management/Administration





Clinariume-TRIALS See Clinical Project Management

Clinical DataFax Systems Inc.DataFax See Data Collection/Management



Clinsoft Corporation 10 Maguire Rd., Ste. 110,Lexington, MA 02421, USA, (781) 778-3700, fax (781)778-3800, www.clinsoft.net

Clintrial, Clintrial Connect, Clintrace Clinsoft Corporationis the world’s largest provider of clinical researchsystems. Its market leadership and innovative technol-ogy position Clinsoft as the industry-standard informa-tion platform for the biopharmaceutical and relatedindustries. Clinsoft’s products enable companies tofocus development resources on product “winners”sooner, and have brought more pharmaceutical productsto market than any other software systems. Visitwww.clinsoft.net.




Datapharm Australia Pty. Ltd.SMART See Clinical Project Management






FW Pharma Systems Four Brindleyplace,Birmingham B1 2JB, UK, +44 121 616 5616, +44 121616 5600, fax +44 121 616 5601, e-mail: [email protected], www.fwpharma.com

IMPACT IMPACT is the pharmaceutical industry’s defacto solution for managing the administration of clinicaltrials—a comprehensive clinical database and route toa wealth of management control techniques. TheHosted Service version of IMPACT brings the world’sleading CTMS to the sponsor-CRO relationship. Easilyand securely.

INITIATOR Initiator is the complete solution for improvingproductivity and access to both operational and planningdata in the Phase 1 arena. It is designed to helppharmaceutical and biotechnology companies and CROsmake earlier decisions in choosing candidate drugproducts to progress to market development.




TrialTrac, Inc. 7336 Santa Monica Blvd. #827,West Hollywood, CA 90046, USA, (323) 930-9842, fax(323) 930-9007, e-mail: [email protected], www.trialtrac.com

SiteTrac SiteTrac is clinical trials management softwaretailored to the needs of research institutions, SMOs,sites, and AROs. It’s easy to use, quick to implement,and customizable. SiteTrac is integrated, and itscomprehensive tracking includes subject information,essential documents, investigator earnings and sponsorpayments, and every step in between.

TrialWorks TrialWorks is the clinical trials managementsystem that produces 100+ reports regarding your criti-cal issues. TrialWorks tracks your projects by study, site,and product. It has an intuitive interface and customiz-able features, and comprehensive tracking—includinginvestigator payments. TrialWorks is also availablethrough our e-service—we are your ASP.

Velos, Inc. 2201 Walnut Ave., Ste. 208, Fremont,CA 94538, USA, (510) 739-4010, fax (510) 739-4018,e-mail: [email protected], www.veloseresearch.com

Velos eResearch Velos eResearch is an investigator-centered, Internet-based software product designed toexpedite the research process by supporting the admin-istration and execution of clinical research and trials.







ValidationAnalyse-it Software, Ltd.Analyse-it Clinical Laboratory See Statistical Analysis











NetRegulusIssueExpert See Adverse Events








SEC Associates, Inc. 3900 Paramount Parkway,Ste. 150, South Morrisville, NC 27560, USA, (919) 467-1997, fax (919) 467-1109, e-mail: [email protected], www.secassociates.com

Computer system compliance consulting SEC Associatesprovides system compliance consulting and computervalidation services for the pharmaceutical, biotechnol-ogy, and medical device industries. SEC’s experiencedconsultants assist clients with regulatory complianceassessments, vendor audits, 21 CFR 11 training, proce-dure development, requirements analysis, and planning,documentation, and execution of computer validationand life-cycle activities.




Validation Wizards International PO Box100, West Mystic, CT 06388-0100, USA, (860) 572-7255 or (860) 572-7259, fax (860) 536-9419, e-mail:[email protected], www.drumkey.com

Validation Wizard for Application User Teams ValidationWizard for Application User Teams is a read-and-clickapplication that trains the trainer and the user team inthe ABCs of computerized system validation (CSV) foruser acceptance of regulated systems. Wizard teachesa common-sense approach for integrating CSV into thenormal workflow of regulated areas.







Web-Based SoftwareServices






BioObjects, Inc. 345 Huelva Ct, Oceanside, CA92057, USA, (760) 722-1792, fax (800) 856-9554, e-mail: [email protected], www.bioObjects.com

Web Services BioObjects specializes in data transforma-tion and integration services. Through Web services andXML, applications can be exposed for use withinportals, wireless applications, and external partners.



ClickFind MED 110 North Main St., Bryan, TX77803, USA, (979) 822-2828 or (877) 552-3463, fax(979) 822-4978, e-mail: [email protected],www.clickfind.com

ClickTrials The ClickTrials Clinical Research Systemprovides robust Web-enabled database managementand reporting solutions that integrate Web, wireless,and telephone systems with database servers forelectronic data capture and data management of clinicaltrials. Services include ClickCRF, ClickRemote, Click-Voice, ClickXML, ClickStat, ClickMonitor, ClickManager,plus Web hosting and consulting services.

Clinariume-TRIALS See Clinical Project Management

ClinicalTrialsNet Inc. 12 John St., Charleston,SC 29403, USA, (843) 965-5598, fax (843) 965-5849,e-mail: [email protected], www.clinicaltrialsnet.com

ClinTriNet ClinicalTrialsNet has developed a proprietarysystem that enables comprehensive data and projectmanagement in a completely online environment. Ourintuitive user interface makes it easier for you to focuson trial management, instead of trial software manage-ment. Contact us to bring efficient technology to yourtrials!










ClinPlus Coding DZS Software Solutions is the leader inSAS-based software solutions for clinical data manage-ment and reporting. The ClinPlus family of productsenables your company to meet its goals in a timely andcost-effective manner.

ClinPlus Data Management See Data Collection/Management

ClinPlus NDA See Statistical Analysis

ClinPlus Remote DZS Software Solutions is the leader inSAS-based software solutions for clinical data manage-ment and reporting. The ClinPlus family of productsenables your company to meet its goals in a timely andcost-effective manner.

ClinPlus Report See Statistical Analysis










IntraLinks, Inc. 1372 Broadway, New York, NY10018, USA, (212) 543-7700 or (212) 543-7710, fax(212) 543-7720, e-mail: [email protected],www.intralinks.com

IntraLinks digital workspaces IntraLinks digitalworkspaces enable pharmaceutical companies tocollaborate efficiently with external parties to organizeand complete work faster and better. Using IntraLinksworkspaces, which are 21 CFR 11 compliant, profes-sionals securely exchange documents, conduct discus-sions, and manage information online. Pharmaceuticalcompanies speed complex, critical activities such asdrug development and licensing while saving on commu-nication, document distribution, and meeting costs.

Intrasphere Technologies, Inc.Systems Integration See IT Consulting





























Velos, Inc.Velos eResearch See Trials Management/Administration



directly transmit information to researchers daily.Replaces the paper subject diaries currently used in20% of all clinical trials worldwide. Features bodydiagrams, visual analog scales. Uses hand-held palmcomputing platform to organize, store, and transmitdata.



TEAMworks Clinical ServicesTRIALink EDC Systems See Electronic Data Capture(EDC)


Winchester Business Systems, Inc.Custom application development See Custom ApplicationDevelopment


Other Applications:Graphics/Presentation

PPD Informatics 84 Sherman St., Cambridge, MA02140, USA, (617) 868-6878, fax (617) 868-2654, e-mail: [email protected], www.ppdinformatics.com

CrossGraphs CrossGraphs systems supported: CD-ROM,Windows 95/NT, HP-UX, Sun Solaris. CrossGraphscombines statistical graphics with cross-tabulation,without programming. Use CrossGraphs to organize yourdata into arrays of graphs to highlight trends and showrelationships among variables. Produce reports with onegraph or thousands with the same interface. Drill downon graphs to see underlying data. Import data from avariety of applications. Relate multiple files together.





Wireless/MobileTechnologies



















Numoda Corporation Curtis Center, 601 WalnutSt., 9th Floor, Philadelphia, PA 19106, USA, (215) 238-8881, fax (215) 238-9995, e-mail: [email protected], www.numoda.com

Numoda mTrial Numoda mTrial for drug, medical device,and biotechnology includes: investigator selection/recruitment, CRA logistics management, clinical trialsproject management, subject visit management, queryresolutions, adverse event tracking, lab supply manage-ment, lab specimen management, study drug inventory/distribution management, randomization, retrospectiveoutcomes research, physician e-sampling and e-detailing, electronic prescription writing.


PHT Corporation 500 Rutherford Ave.,Charlestown, MA 02129, USA, (617) 973-1600, fax(617) 973-1601, e-mail: [email protected],www.phtcorp.com

Esendant Investigator LogPad is PHT Corp.’s hand-helddevice for clinical trials allowing off-line, real-timeelectronic data capture of eCRF information at the inves-tigator site. Eliminates conventional paper data sources,provides mobile clinical data entry and retrieval, andenables worldwide study monitoring. Uses hand-heldplatform based on powerful Fujitsu pen computers with10.4-inch color display.

Esendant Patient LogPad is PHT Corp.’s revolutionaryhand-held device enabling subjects to instantly and

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