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24| Adverse Events
Clinical Project Management
Custom Application Development
Data Collection and Management
25| Company Directory
27| Data Mining and Visualization
Document Management
Electronic Data Capture (EDC)
28| Electronic Submissions
IT Consulting
Knowledge Management
Medical Imaging
Statistical Analysis
29| Training
Trials Management and Administration
Validation
Web-Based Software
30| Wireless/Mobile Technologies
Other Applications
IT Solutions
Your information technology directory
PharmaTech Solutions
Services PharmaTech Solutions is a patient management
organization (PMO). We accelerate enrollment of
thoroughly qualified patients and maximize patient compliance and retention. Our team understands disease
states, the challenges of enrolling a clinical trial, collaboration with investigator sites, and our responsibility in
educating and communicating with patients.
TrialTrac, Inc.
SiteTrac See Trials Management/Administration
TrialWorks See Trials Management/Administration
The Applied Clinical Trials 2002 IT Solutions Directory presents information
about applications used in the conduct of clinical trials. It is compiled from
information provided by application developers, and Applied Clinical Trials
cannot accept responsibility for the accuracy of the information they supplied.
Custom Application Development
ArcStream Solutions
Services See Wireless/Mobile Technologies
BBK Healthcare, Inc.
TrialCentral.net See Knowledge Management
CiteLine, Inc.
CiteLine Professional Internet See Data Mining/Visual-
Adverse Events
Aris Global
Aris Global E2B Gateway See Electronic Submissions
Protocol Manager, our clinical trials management
system. Automatically generates CIOMS and
MEDWATCH 3500 reports for electronic submission.
Uses MedDRA and/or user-defined dictionaries.
Conforms to 21 CFR part 11.
Assured Information Systems
PV-Works PV-Works is the leading workflow-driven
pharmacovigilance system. It is 21 CFR Part 11 compliant, includes MedDRA coding and E2B. The software
can inherit your own workflow processes and can be
installed on site or run as an outsourced pharmacovigilance service. Assured and PV-Works are able to meet
your pharmacovigilance system needs.
Advanced Clinical Software
DZS Software Solutions, Inc.
Clinical DataFax Systems Inc.
ClinPlus Coding See Other Applications
DataFax See Data Collection and Management
MAJARO InfoSystems Inc.
ClinLogic
ClinAccess Dictionary Coder See Data Collection/
ClinProject ClinProject is a Clinical Trials Management
Management
application providing real-time insight into study progress.
The system provides crucial information for decisions
early in the study cycle before CRFs have been retrieved
and entered into clinical data management. From site initiation, through grant payment disbursement, ClinProject is
an end-to-end solution.
NetRegulus
IssueExpert IssueExpert provides all the tools and
capabilities necessary for collecting, documenting,
tracking, trending, and reporting product quality issues
including adverse events, corrective and preventive
actions (CAPA), audits, complaints, nonconformities,
vigilance reporting, product tracking, and more. This
easy-to-use and 21 CFR Part 11-compliant module is
fully configurable, scalable, and secure.
StudyExpert See Trials Management/Administration
Oriam
ES1-SafetyManager Parameterizable system for
adverse event tracking and declaration (local and international standard report forms). Standard coding dictionaries loading available (MedDRA, WHO-DRUG, etc.).
Case report versioning included. Compliant with ICH
E2B and M2 for electronic submission, FDA 21 CFR
Part 11 for electronic records). Ability to query the
database.
Phase Forward Incorporated
Clinical Project Management
Study Manager See Trials Management/Administration
Cardio Control
Cardio Perfect See Medical Imaging
StudyBuilder Design Consultancy See IT Consulting
Systemsmith
Services Systemsmith is a Microsoft Certified Partner
Custom application development Winchester Business
Systems develops software applications for pharmaceutical, biotechnology, and medical device companies
designed to improve drug and product development
processes. Winchester implements systems for multisite/multivendor clinical trials projects, electronic data
collection, workflow management and project management systems, information management, and exception
reporting for decision support.
TrialBridge See Trials Management/Administration
Cytel Software Corp.
EaSt See Statistical Analysis
DataLabs
DataLabs CTMS See Electronic Data Capture
Datapharm Australia Pty. Ltd.
SMART SMART (Smooth Monitoring A Resource Tool) was
developed by Datapharm to assist project managers of
clinical trials to assess and track monitoring requirements
over several projects and to adjust estimates based on
actuals iteratively. It is quick to use and allows monitoring
of actuals vs. estimated progress milestones.
Data Collection and Management
Acumen Healthcare Solutions, LLC
TracIt2k EDC System See Electronic Data Capture
Adapt~EDC, LLC
Adapt~EDC Clinical Trials Suite See Electronic Data
IMPACT See Trials Management/Administration
Capture
ICTI
Aris Global
interactive trial management solutions using state-of-theart IVRS development tools. Applications include centralized patient randomization, drug supply management,
IVRS-based patient unblinding, patient diary data collection, accelerated patient referral, and automated information distribution. ICTI is the leader in clinical trial material
management with the introduction of their powerful
forecasting and supply chain management tool.
Insightful
REGISTER REGISTER is the most comprehensive global
drug registration and tracking system. Compliant with the
latest regulatory guidelines, REGISTER provides for
reliable and accurate product information (e.g., preferred
name, ingredients, International birth date, registration
renewals formulations, approval status, registration
number, etc), global monitoring of activities, and compliance for manufacturing and QC regulations.
Cardiff Software, Inc.
S+SeqTrial S+SeqTrial is an S-PLUS software library for
adWatch adWatch helps the clinical trial team track AEs
Oriam
APPLIED CLINICAL TRIALS SUPPLEMENT
Administration
StudyBuilder Limited
CTIS Inc.
Winchester Business Systems, Inc.
24
Investigator DataWeb System See Trials Management/
Winchester Business Systems, Inc.
designing, monitoring, and analyzing clinical trials using
group sequential methods. The main design focus is
choosing the sample size that allows the clinical trial to
discriminate between the null and alternative hypotheses,
thereby answering the scientific questions of interest.
and SAEs as well as product inquiries and complaints
from around the world. Integrates seamlessly with
Invantage, Inc.
TrialXS/TMS See Trials Management/Administration
Interactive Trial Management Solutions ICTI provides
Synteract
trials software products, Formedix also undertakes
custom software design using Java, C, C++, XML-technologies and database integration services. Our customizable
paper scanning and indexing solutions have been
integrated with handwriting-recognition and barcode-recognition systems, together with clinical laboratory information management systems.
ClinSource
Relsys International
SynCoder SynCoder is a SAS application that implements the MedDRA terminology, as well as COSTART
and WHO-DRUG dictionaries, for coding adverse event
and medication text reported during clinical trials or
post-marketing. The product requires SAS v8.1 or
higher, and works with SAS v6 or v8 databases.
Custom software design In addition to our core clinical-
ClinSite See Trials Management/Administration
FW Pharma Systems
oper of specialized software for managing product risk
associated with pharmaceuticals and medical devices.
The company’s software solutions empower manufacturers to meet current product safety regulations and
internal quality objectives. Argus Safety is the world’s
top selling global drug safety software solution.
Formedix Ltd.
focused on custom software development for clinical
trials. We have experience developing mission-critical
systems for large sites, CROs, and patient recruiting
firms. Our combination of clinical trials domain expertise
and technical skill makes Systemsmith the best choice for
all your pharmaceuticals-related custom software development needs.
Clintrace The Clintrace safety tracking and reporting
system offers comprehensive data management tools
that easily collect, code, and analyze adverse events,
and helps sponsors to meet the reporting requirements
and deadlines of regulatory agencies worldwide.
Argus Safety Relsys International is the leading devel-
ization
EC1-TrialManager See Trials Management/Administration
actmagazine.com
Wish you were here?
To list your company’s product in the
2003 IT Solutions Directory,
email your contact information to
[email protected]
August 2002
Company Directory
A–B
Acumen Healthcare Solutions, LLC
14252 23rd Avenue North
Plymouth, MN 55447 USA
763-559-8232 ext. 24
fax: 765-559-2821
[email protected]
acumenhealthcare.com
BioObjects, Inc.
345 Huelva Court
Oceanside, CA 92057 USA
760-722-1792
fax: 800-856-9554
[email protected]
www.bioobjects.com
C–D
Adapt~EDC, LLC
5872 York Road
P.O. Box 663
Lahaska, PA 18931 USA
215-794-5691
fax: 215-794-5691
[email protected]
www.adaptedc.com
Cardiff Software, Inc.
3220 Executive Ridge Drive
Vista, CA 92083 USA
760-936-4500
fax: 760-936-4800
[email protected]
www.cardiff.com
Adobe Systems Inc.
345 Park Avenue
San Jose, CA 95110 USA
408-536-6000
fax: 408-537-6000
www.adobe.com
Cardio Control
Mercuriusweg 1
Delft, 2624 BC, The Netherlands
+31 15 750 5000
fax: +31 15 750 5050
[email protected]
www.cardiocontrol.com
Advanced Clinical Software
212 4th Avenue
Seattle, WA 98121-2025 USA
206-728-0313
fax: 206-728-0469
[email protected]
www.ClinicalSoftware.net
Advanced Systems
Development
1650 Borel Place, Suite 209
San Mateo, CA 94402 USA
650-292-5314
fax: 650-292-5302
[email protected]
www.advasys.com
AlQemy
305 Cotton Bay Way
Simpsonville, SC 29681 USA
864-284-9918
www.alQemy.com
Analyse-it Software, Ltd.
P.O. Box 103
Leeds, LS27 7WZ UK
+44 113 210 0708
fax: +44 113 229 8424
[email protected]
www.analyse-it.com
ArcStream Solutions
311 Arsenal Street
Watertown, MA 02472 USA
617-393-2400
[email protected]
www.arcstream.com
Aris Global
2777 Summer Street
Stamford, CT 06905 USA
203-588-3000
fax: 203-356-1673
[email protected]
www.arisglobal.com
Assured Information Systems
Equity House, 18 Market Square
St. Neots, Cambs PE19 2AF UK
+44 1 480 21 22 23
fax: +44 1 480 21 64 95
[email protected]
www.assured.co.uk
BBK Healthcare, Inc.
320 Needham Street, Suite 150
Newton MA 02464 USA
617-630-4477
fax: 617-630-5090
[email protected]
www.bbkhealthcare.com
August 2002
Carevoyance Telematics
1228 Hamilton Street Suite 503
Vancouver, BC V6B 2S8 Canada
604-642-2273
fax: 604-642-2293
[email protected]
www.carevoyance.com
CB Technologies, Inc.
350 Eagleview Boulevard
Exton, PA 19341-1155 USA 610280-7400
fax: 610-280-0440
[email protected]
www.cbtech.com
fax: 310-921-2835
[email protected]
www.clinlogic.com
ClinSource
Mechelsesteenweg 455, Bus 2
Kraainem, B-1950 Belgium
+32 2 766 00 80
fax: +32 2 766 00 81
CTIS Inc.
1355 Piccard Drive Suite 450
Rockville MD 20850 USA
301-948-3033
fax: 301-948-2242
[email protected]
www.ctisinc.com
Cytel Software Corp.
675 Massachusetts Avenue
Cambridge, MA 02139 USA
617-661-2011
fax: 617-661-4405
[email protected]
www.cytel.com
Datafarm Inc.
275 Boston Post Road, Suite 2
Marlborough, MA 01752 USA
508-624-6454
fax: 508-624-0848
[email protected]
www.datafarminc.com
DataLabs
17310 Redhill Avenue,
Suite 200
Irvine, CA 92614 USA
949-851-2030
fax: 949-851-2043
[email protected]
www.datalabs.com
Cetan Technologies
4106 Shipyard Boulevard
Wilmington, NC 28403 USA 910452-2253
fax: 910-452-2355
[email protected]
cetantechnologies.com
Datapharm Australia Pty. Ltd.
56-56A Thompson Street
Drummoyne, NSW 2047
Australia
+612 9719 2800
fax: +612 9719 2811
[email protected]
www.datapharm.com.au
CiteLine, Inc.
1608 Merlot Court, 2nd Floor
Petaluma, CA 94954 USA
888-436-3012
fax: 707-762-0666
[email protected]
www.citeline.com
DataSpectrum
6131 Falls of Neuse Road,
Suite 200
Raleigh, NC 27609 USA
888-255-5300
[email protected]
www.dataspectrum.com
Clinical DataFax Systems Inc.
21 King Street West, Suite 305
Hamilton, ON L8P 4W7 Canada
905-522-3282
fax: 905-522-7284
[email protected]
www.datafax.com
DATATRAK International, Inc.
6150 Parkland Boulevard,
Suite 100
Mayfield Heights, OH 44124
USA
440-443-0082
fax: 216-921-6702
[email protected]
www.datatraknet.com
ClinicalTrialsNet Inc.
12 John Street
Charleston SC 29403 USA
843-965-5598
fax: 843-965-5849
[email protected]
www.clinicaltrialsnet.com
Clinitrac
St. Eriksgatan 113
Stockholm, S-113 43 Sweden
+46 8 5088 0600
fax: +46 8 5088 0609
[email protected]
www.clinitrac.com
ClinLogic
18436 Hawthorne Boulevard
Suite 208
Torrance, CA 90504 USA
310-921-6025
DATATRAK Deutschland, GmbH
Am Propsthof 80
53121 Bonn, Germany
+49 228 979 8330
fax: +49 228 979 8334
[email protected]
www.datatraknet.com
Drumbeat Dimensions, Inc.
P.O. Box 100
West Mystic, CT 06388-0100
USA
860-572-7255
fax: 860-536-9419
[email protected]
www.drumkey.com
DZS Software Solutions, Inc.
1661 Route 22 West
Bound Brook NJ 08805 USA
732-764-6969
fax: 732-764-6755
[email protected]
clinplus.com
E–F
eOriginal Inc.
351 West Camden Street,
Suite 800
Baltimore, MD 21201 USA
410-659-9796
fax: 410-659-9799
[email protected]
www.eoriginal.com
ePharmaLearning
39 High Gate Lane
Blue Bell, PA 19422 USA
215-643-3318
fax: 509-692-4939
[email protected]
www.epharmalearning.com
etrials, Inc.
2701 Aerial Center Parkway,
Suite 100
Morrisville NC 27560 USA
919-653-2000
fax: 919-653-2001
[email protected]
www.etrials.com
First Consulting Group
575 E. Swedesford Road,
Suite 200
Wayne, PA 19087 USA
610-989-7000
fax: 610-989-7100
[email protected]
lifesciences.fcg.com
Fisher Clinical Services
7554 Schantz Road
Allentown, PA 18106 USA
610-391-0800
fax: 610-391-0801
[email protected]
www.fisherclinicalservices.com
Formedix Ltd.
1 Ainslie Road, Hillington
Glasgow G52 4RU UK
+44 141 585 6434
fax: +44 141 585 630
35 Corporate Drive, Fourth Floor
Burlington, MA 01803
781-685-4995
fax: 781-685-4601
[email protected]
www.formedix.com
FW Pharma Systems
Four Brindleyplace
Birmingham, B1 2JB UK
+44 121 616 5616
fax: +44 121 616 5601
[email protected]
www.fwpharma.com
G–H
Galt Associates, Inc.
46040 Center Oak Plaza,
Suite 100
Sterling, VA 20166 USA
703-433-6104
[email protected]
www.DrugSafety.com
Gupta Programming
213 Goldenwood Circle
Simi Valley, CA 93065 USA
805-577-8877
actmagazine.com
fax: 413-383-3543
[email protected]
www.guptaprogramming.com
Healthcare Technology Systems
7617 Mineral Point Road,
Suite 300
Madison, WI 53717
608-827-2440
fax: 608-827-2444
[email protected]
www.healthtechsys.com
Honeywell/POMS
13655 Dulles Technology Drive
Herndon, VA 20171 USA
703-793-4400
fax: 703-793-4401
www.poms.com
I–J
ICTI
1040 Stony Hill Road,
Suite 200
Yardley, PA 19067 USA
267-685-4284
fax: 267-685-4262
[email protected]
www.icti-usa.com
iMedRIS Data Corp.
36213 Highland Avenue, Yucaipa
CA 92399 USA
909-520-9164
fax: 909-520-0031
[email protected]
www.iMedRIS.com
InferMed Limited
23 Bedford Square
London, WC1B 3HH UK
+44 20 7269 3715
fax: +44 20 7269 3716
[email protected]
www.infermed.com
InfoPro Solutions
31200 Via Colinas, Suite 102
Westlake Village, CA
91362-3953 USA
818-879-0075
fax: 818-879-7303
[email protected]
www.infoprosolutions.com
Insightful
1700 Westlake Avenue North,
Suite 500
Seattle WA 98109 USA
fax: 206-283-8802
fax: 206-283-8691
[email protected]
www.insightful.com
IntraLinks, Inc.
1372 Broadway
New York, NY 10018 USA
212- 543-7700
fax: 212-543-7801
[email protected]
www.intralinks.com
Invantage, Inc.
201 Broadway, #601
Cambridge, MA 02139 USA
617-577-7844
fax: 617-249-0844
[email protected]
www.invantage.com
invivodata, inc.
5615 Scotts Valley Drive,
Suite 150
Scotts Valley, CA 95066 USA
831-438-9550
fax: 831-440-1770
APPLIED CLINICAL TRIALS SUPPLEMENT
25
[email protected]
www.invivodata.com
www.netregulus.com
O–P
K–L
KIKA Medical
15 Rue du Géneral Drouot
Nancy, 54000 France
+33 3 83 30 40 31
fax: +33 3 83 35 22 08
[email protected]
www.kikamedical.com
LifeTree Technology, LLC
41093 County Center Drive
Temecula, CA 92591 USA
800-843-7477
fax: 800- 418-4333
[email protected]
www.lifetree-tech.com
Liquent, Inc.
1300 Virginia Drive Suite 125
Fort Washington, PA 19034 USA
800-515-3777
fax: 215-654-7724
[email protected]
www.liquent.com
Logos Technologies Ltd.
Chiltern House, Feathers Yard
Basingstoke Hampshire RG21
7AT UK
+44 1256 478900
fax: +44 1256 473332
[email protected]
www.logostechnologies.com
M–N
MAJARO InfoSystems Inc.
1731 Technology Drive,
Suite 560
San Jose, CA 95110 USA
408-562-1890
fax: 408-562-1899
[email protected]
www.majaro.com
Mini Mitter Co.
20300 Empire Avenue,
Building B-3
Bend, OR 97701 USA
800-685-2999
fax: 541-322-7277
[email protected]
www.minimitter.com
NetRegulus
One Tower Lane Suite 1700
Oakbrook Terrace IL 60181 USA
888-707-6900
fax: 630-573-6050
[email protected]
617-868-6878
fax: 617-868-2654
[email protected]
www.ppdi.com
Premier Research/
SCP Communications
30 South 17th Street
Philadelphia, PA 19103 USA
215-282-5500
fax: 215-636-9726
[email protected]
www.premier-research.com
Oriam
U.S.
100 Cummings Center,
Suite 311 H
Beverly, MA 01915 USA
[email protected]
www.oriam.com
Europe:
8 Parvis de St-Maur, Saint-Maur,
94106 France
+33 1 55 97 03 20
fax: +33 1 55 97 03 22
[email protected]
www.oriam.com
Perceptive Informatics
200 West Street
Waltham, MA 02451 USA
781-487-9900
fax: 781-434-5916
[email protected]
www.perceptive.com
PerMedics, Inc.
1475 South Victoria Court
San Bernardino, CA 92408 USA
877-4PERMED
fax: 909-478-5016
[email protected]
www.permedics.com
PharmaTech Solutions
3534 South College Road,
Suite I
Wilmington, NC 28412 USA 910395-5674
fax: 910-392-7275
[email protected]
www.pharmatechsolutions.com
Pharsight Corporation
800 West El Camino Real,
Suite 200
Mountain View, CA 94040 USA
650-314-3800
fax: 650-314-3810
[email protected]
www.pharsight.com
Phase Forward
Incorporated
1440 Main Street
Waltham, MA 02451 USA
888-703-1122
fax: 781-890-4848
[email protected]
www.phaseforward.com
PPD Informatics
84 Sherman Street
Cambridge, MA 02140 USA
ProIRB Plus, Inc.
6020 44th Avenue North
St. Petersburg FL 33709 USA
727-545-5314
fax: 727-541-2433
[email protected]
proirb.com
Propack Data Corp.
2000 Regency Parkway,
Suite 375
Cary, NC 27511 USA
919-465-1741
fax: 919-465-1742
[email protected]
www.propack-data.com
Q–R
Relsys International
16267 Laguna Canyon Road
Irvine, CA 92618 USA
949-453-1715
fax: 949-453-1817
[email protected]
www.relsys.net
Resampling Stats, Inc.
612 North Jackson Street
Arlington, VA 22201 USA
703-522-2713
fax: 703-522-5846
[email protected]
www.resample.com
S–T
S–T
SEC Associates, Inc.
3900 Paramount Parkway,
Suite 150 South
Morrisville, NC 27560 USA
919-467-1997
fax: 919-467-1109
[email protected]
www.secassociates.com
SiteWorks Solutions
6409 Quail Hollow Road
Memphis,TN 38120
888-707-SITE(7483)
fax: 901-680-0140
siteworkssolutions.com
Stat-Ease, Inc.
2021 East Hennepin Avenue,
Suite 480
Minneapolis, MN 55413 USA
612-378-9449
fax: 612-378-2152
[email protected]
www.statease.com
StudyBuilder Limited
John Eccles House
Robert Robinson Avenue
The Oxford Science Park,
OX4 4GP UK
+44 1865 338 092
fax: +44 1865 338 100
[email protected]
www.studybuilder.com
SyMetric Sciences, Inc.
1-2082 Sherbrooke West
Montreal, QC H3H 1G5 Canada
514-935-4562
fax: 514-935-9911
[email protected]
www.symetric.ca
Symfo
632 Massachusetts Avenue,
Suite 401
Cambridge, MA 02139
866-88-SYMFO
www.symfo.com
Synergy Software
2457 Perkiomen Avenue
Reading, PA 19606 USA
610-779-0522
fax: 610-370-0548
[email protected]
www.synergy.com
Synteract
187 Calle Magdalena
Encinitas, CA 92024 USA
760-634-2133
fax: 760-634-2170
[email protected]
www.synteract.com
Systemsmith
18436 Hawthorne Boulevard,
Suite 208
Torrance, CA 90504 USA
310-921-2735
fax: 310-921-2835
[email protected]
www.systemsmith.com
Target Health
261 Madison Avenue, 24th Floor
New York, NY 10016 USA
212-681-2100
www.targethealth.com
TEAMworks Clinical Services
6 Stirling House, Stirling Road
The Surrey Research Park
Guildford Surrey GU2 7RF UK
+44 1483 510360
fax: +44 1483 302 528
[email protected]
www.teamworks.de
TrialTrac, Inc.
45 Main Street, Suite 405
Brooklyn, NY 11021 USA
718-237-4000
fax: 718-237-4688
[email protected]
www.trialtrac.com
U–V
Validation Wizards
International
P.O. Box 100
West Mystic, CT 06388-0100
USA
860-572-7255
fax: 860-536-9419
[email protected]
www.drumkey.com
Velos, Inc.
2201 Walnut Avenue,
Suite 208
Fremont, CA 94538 USA
510-739-4010
fax: 510-739-4018
[email protected]
www.veloseresearch.com
Vitalograph Ltd.
Maids Moreton
Buckingham, Bucks
MK18 1SW UK
+44 1280 827120
fax: +44 1280 823302
[email protected]
www.vitalograph.co.uk
W–Z
Wimmer Systems, LLC
3008 Cochise Drive
Independence, MO 64057 USA
816-795-5177
fax: 816-795-5177
[email protected]
www.wimmersystems.com
Winchester Business Systems, Inc.
50 Cross Street
Winchester, MA 01890 USA
781-729-7150
fax: 781-729-7211
[email protected]
wbsnet.com
based on patient enrollment and site quality—not the
site’s technological capability.
InferMed Limited
DZS Software Solutions, Inc.
MAJARO InfoSystems Inc.
Clinical DataFax Systems Inc.
ClinPlus Data Management DZS Software Solutions is
the leader in SAS-based software solutions for Clinical
Data Management and Reporting. The ClinPlus family of
products enable your company to meet its goals in a
timely and cost effective manner.
DataFax A complete clinical trials management solution
etrials, Inc.
ClinAccess Dictionary Coder SAS-powered. Integrates
with ClinAccess or as standalone. Works with any dictionary, 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. Used with
entire system, images dynamically appear for easy coding.
TELEform Cardiff TELEform streamlines collection of data
from paper and online forms. Built-in business rules and
intuitive validation processes quickly capture accurate
information. Operators spend seconds verifying data
rather than minutes manually keying entire forms.
Connects to leading clinical database applications, including SAS, SPSS, Oracle Clinical, and Clintrial.
using CRFs and simple fax technology at the clinical sites
and powerful software at the coordinating center including:
intelligent character recognition from faxed CRFs, query
tracking, standard reports, audit trails, study setup tool,
bookmarked PDFs of patient CRFs, acceptance test kit,
and much more.
TrialXS/CRF See Electronic Data Capture
QuickStudy etrials, Inc. provides data management
technologies and services for the healthcare industry.
etrials offers efficient data management products and
services for collecting, monitoring and assessing quantitative and qualitative study data. etrials leads biotech and
pharmaceutical companies through the critical processes
involved in successfully migrating from paper-based to
electronic data capture methods.
DataSpectrum
Formedix Ltd.
Services DataSpectrum is a data and statistical services
Formedix Origin, Formedix Transform, and Formedix
Express See Electronic Data Capture
ClinSource
provider. DataSpectrum’s “no barriers” approach
integrates all data capture methods—Internet, paper and
fax—into one validated system. This “mix and match”
capability gives you the flexibility to pick a study site
26
APPLIED CLINICAL TRIALS SUPPLEMENT
Healthcare Technology Systems
Clinical IVRS See Electronic Data Capture
actmagazine.com
MACRO See Electronic Data Capture
NetRegulus
IssueExpert See Adverse Events
RegistryExpert RegistryExpert allows users to link and
track products, patients, care facilities, capital equipment,
medical professionals, and more. Register and track
capital equipment and products by product number,
serial/lot number, date or your own system. Features
multiple address capability to quickly locate patients with
products in critical situations.
PerMedics, Inc.
Surveyor See Trials Management/Administration
Pharsight Corporation
August 2002
Pharsight Knowledgebase Server Collaborative data
AlQemy
Carevoyance Telematics
management for 21 CFR Part 11 compliance.
PDF Form Services Design and deployment services for
Phase Forward Incorporated
InForm Architect Phase Forward’s powerful InForm Archi-
electronic forms (PDF) used for secure data collection—
patient diaries, online data submissions, and data reporting.
QuickZilver See Web-Based Software Services
tect development tool quickly designs, tests, validates
and documents Web-based clinical trials.
Cardiff Software, Inc.
Catalyst Using the RIM BlackBerry 957, Catalyst collects,
analyzes, and transmits data in real time, while continuously monitoring for adverse events and assuring trial
protocol adherence. Better quality data, reduced time to
database lock, and safe management of adverse events
results in significantly reduced risk for our customers.
TELEform See Data Collection and Management
CB Technologies, Inc.
Drumbeat Dimensions, Inc.
Dynamic DRUMBEAT for Clinical Trial Supplies provides the
basic DRUMBEAT Tools for assessing compliance, linking
policies and procedures to DRUMBEAT Concepts and
worldwide regulations, and assessing the quality of your
documents and your level of compliance.
MetaTrial CB Technologies is the premier provider of
technology tools and services to the life science industries. CB’s solutions include MetaTrial clinical electronic
data capture software and myMetaTrial Management
Portal. These innovative solutions enable greater efficiencies in the clinical trials process. For more MetaTrial information, visit www.metatrial.com.
eOriginal Inc.
ClinicalTrialsNet Inc.
InForm See Electronic Data Capture
PPD Informatics
TableTrans A data transformation tool.
SyMetric Sciences, Inc.
SyMetric Clinical Data Management System Comprehensive data management system for clinical trials including
full support for double data entry, multivariate data validation, data dictionary, autoencoders for all standard dictionaries (ICD9, MedDRA, WHO, etc.), query management,
flexible export to ASCII, HTML, and SAS, etc. Complies
with all regulatory requirements. For more information,
please visit our Web site.
Vitalograph Ltd.
Spirotrac Centralized Spirometry System See Electronic
Data Capture
Wimmer Systems, LLC
DaCS (Data Compliance System) DaCS is the original
stand-alone 21 CFR 11 compliance solution for Microsoft
Excel, providing security, audit trails, and true electronic
signatures in a low-cost, low-overhead, and customizable
solution. Free demonstration software allows you to
conduct a full evaluation before purchasing.
Winchester Business Systems, Inc.
paraFILE paraFILE helps users capture, author, edit,
review, approve, and publish electronic documents from
any computer source or application. paraFILE fosters an
environment where document creation, review, and
approval is collaborative among authors, approvers, and
reviewers within and outside the corporation. 21 CFR Part
11 compliant.
Data Mining and Visualization
CiteLine, Inc.
CiteLine Professional Internet Editorially supported application featuring parallel searching, site monitoring, and
“hide my identity.” Utilized by thousands of industry
knowledge workers to maximize the value of the Web for
their business information needs. Includes information
on competitor clinical trials, epidemiology, disease,
medical economics, regulatory, and more.
Dynamic DRUMBEAT for Clinical Trials Supplies (CTS)
eOriginal eCore Business Suite 2.0 eOriginal Inc. is the
leading provider of enterprise software to enable organizations to execute secure online business transactions
creating legally enforceable electronic original documents.
By leveraging the eOriginal eCore Business Suite 2.0,
companies are able to participate in end-to-end electronic
transactions, dramatically reducing paperwork costs,
increasing profit margins and accelerating contract cycles.
ClinTriNet ClinicalTrialsNet has developed a Web-based
system that enables comprehensive data and project
management in a regulatory compliant, on-line environment. Our intuitive user interface makes it easier for you
to focus on trial management, instead of trial software
management. Contact us to bring efficient technology to
your trials!
Clinitrac
Clinitrac Patient Diary Wireless patient diary for collec-
First Consulting Group
FirstDoc CRFs FCG has combined the industry’s best
tion and monitoring of patient data in real time.
practices, state-of-the-art technology, and consulting
services to produce FirstDoc CRF, the industry’s only
Documentum-based, prepackaged electronic document
management solution for case report forms (CRFs). Our
solution addresses highly complex document management and regulatory requirements associated with CRFs.
ClinSource
TrialXS/CRF TrialXS/CRF is a Web-enabled CRF design
tool to create, design, program and change Clinical
Research Forms in a fast, accurate, remote and secure
environment. It works fully integrated with the TrialXS trial
management and data capture system.
IntraLinks, Inc.
DataLabs
IntraLinks digital workspaces IntraLinks digital
DataLabs CTMS DataLabs CTMS is the first Internetbased product that integrates the elements of project,
data and document management into a single application.
Based in Microsoft’s .NET framework and servers, this
integrated approach provides significant benefits, including an accelerated time to market, lower development
costs and improved research quality.
workspaces enable pharmaceutical companies to collaborate efficiently with external parties to organize and
complete work faster and better. Using IntraLinks
workspaces, which are 21 CFR Part 11 compliant, professionals securely exchange documents, conduct discussions, and manage information online. Pharmaceutical
companies speed complex, critical activities such as drug
development and licensing while saving on communication, document distribution, and meeting costs.
Datapharm Australia Pty. Ltd.
eCRF eCRF is a remote data capture tool allowing sites to
ClinAccess PowerServer See Data Collection and
send clinical trial data electronically to Datapharm’s
secure server. Fields are programmed with edit checks
and database lookups allowing quick access to clean data
which can be viewed on the Web. System setup and
maintenance is cost effective.
Liquent, Inc.
CoreDossier See Knowledge Management
MAJARO InfoSystems Inc.
Management
DATATRAK International
Insightful
Pharsight Corporation
DATATRAK EDC DATATRAK International, Inc., with offices
Insightful Miner Insightful Miner Desktop Edition is the
PKS Reporter Template-driven authoring of compound
first affordable, no-compromise data mining workbench
that gives new data miners and skilled modelers the
ability to deploy predictive intelligence throughout the
enterprise.
documents and reports.
NetRegulus
ReportExpert ReportExpert provides detailed, Webenabled internal analytical reporting for decision makers,
as well as regulatory reporting for all phases of a
product’s life cycle. Includes a library of standard reports
and intuitive tools to create unlimited ad hoc reports.
Generates and e-mails regularly scheduled reports. Pulls
data from related and nonrelated database sources,
regardless of platform.
Phase Forward Incorporated
Clintrial See Data Collection and Management
Synergy Software
KaleidaGraph KaleidaGraph is an easy-to-use 2D graphing
and data analysis application for scientists. Easily
customize every aspect of your plot, perform flexible
regression analysis and add error bars. Perform basic
statistics on your data including t-test. Print your graph or
export to PowerPoint, the Web, and other favorite applications.
Winchester Business Systems, Inc.
paraLAB-Electronic LABOOK paraLAB-Electronic LABOOK
is a document repository meant to augment and/or
replace the paper data notebook used by scientists and
engineers. paraLAB can contain documents that manage
files from practically any computer source.
Acumen Healthcare Solutions, LLC
TracIt2k EDC System TracIt2k is the most affordable and
flexible EDC solution available today. Quickly and easily
create, design and modify your own e-CRFs complete with
error checks and comprehensive audit trails. If you need a
system to accommodate off-line and/or on-line data entry
without changing your database, TracIt2k can do it affordably.
Adapt~EDC, LLC
Adobe Systems Inc.
Adobe Acrobat Acrobat 5.0 software lets you convert any
Cardiff Software, Inc.
document to an Adobe Portable Document Format (PDF)
file. Anyone can open your document across a broad
range of hardware and software, and it will look exactly as
you intended. Distribute documents with complete visual
fidelity via print, the Web or mobile devices.
LiquidOffice The Cardiff LiquidOffice eForm Management
August 2002
DZS Software Solutions, Inc.
ClinPlus Remote See Web-Based Software Services
etrials, Inc.
Electronic Data Capture (EDC)
Adapt~EDC Clinical Trials Suite Adapt~EDC serves the
pharmaceutical and biotechnology industries by developing and supporting advanced software applications and
outsourcing services designed to dramatically reduce the
costs and time associated with the collection, distribution
and analysis of clinical trial data. Adapt~EDC enables
companies to make go/no-go decisions much earlier than
ever before possible.
Document Management
in Cleveland, Ohio, and Bonn, Germany, specializes in
electronic data capture using DATATRAK EDC. The product
suite operates in centralized or stand-alone modes, and
offers state-of-the-art security and real-time data entry and
review. Electronic site assessment and Web-based training are offered.
System is a complete XML-based solution that is used to
automate forms and the business processes they drive.
LiquidOffice uses XML, HTML and PDF standards to put
forms into an online system—complete with routing,
online approval, digital signatures and data processing.
QuickStudy See Data Collection and Management
Formedix Ltd.
Formedix Origin, Formedix Transform, and Formedix
Express Formedix Origin is our standards-based trial
authoring package that allows the specification of a
complete clinical trial, including the efficient re-use of
previous trial components. Formedix Transform is our
automated trial generation service, quickly and safely
transforming Origin-based specifications into working
trials. The result is Formedix Express, a real-time
electronic data capture and collaboration solution that is
powerful, flexible and easy to use. Seamless
scanning/integration of paper-based materials with
electronic trial records. Also: custom software services.
FW Pharma Systems
INITIATOR See Trials Management/Administration
Healthcare Technology Systems
Clinical IVRS Healthcare Technology Systems (HTS) is the
world leader in developing and providing clinical interactive
goice response systems (IVRS) to gather data directly
from patients. HTS offers more than 30 IVR clinical rating
scales, including the HAMD, plus research and clinical
expertise.
InferMed Limited
MACRO MACRO is a modular system for running Internetbased multicenter trials. MACRO’s intuitive, interactive
actmagazine.com
APPLIED CLINICAL TRIALS SUPPLEMENT
27
tools for remote study definition, on-line and off-line
remote data entry and remote study monitoring reduce
set-up time and improve time to database closure.
MACRO is the only independent EDC system fully
integrated with Oracle Clinical.
invivodata, inc.
invivosystem The invivosystem is a patient-focused
electronic diary solution for collecting real-time, real-world
patient self-report data for clinical research that is valid,
reliable, and timely. By combining behavioral science
methods and proven Web and handheld technologies, the
invivodata patient management system consistently delivers patient compliance at unmatched levels.
LifeTree Technology, LLC
LifeTree ICTM LifeTree ICTM is a comprehensive Internetbased solution that accelerates trials, setting the
standard for trial data management. ICTM's Web-based
system simplifies study design and data management,
automates electronic case report forms (eCRFs) and
accelerates data entry and validation. ICTM answers the
demand for exceptional data management.
leading EDC innovator and vendor with experience in the
implementation, deployment and support of e-clinical
trials across all phases and international geographies.
With offices in Switzerland, UK, Germany, Singapore, and
USA, TEAMworks is also establishing itself as a global
leader in applying innovative Internet technologies
together with high performance processes to automation
of the clinical trial process.
Vitalograph Ltd.
Spirotrac Centralized Spirometry System Vitalograph has
been a world leader in respiratory diagnostics for almost
40 years. The Centralized Spirometry System transmits
encrypted data everyday via email from investigator sites
direct to the sponsor or via a dedicated and unique overread software system where data quality is ensured on a
daily basis.
Wimmer Systems, LLC
DaCS (Data Compliance System) See Data Collection
and Management
Electronic Submissions
Logos Technologies Ltd.
ALPHADAS Logos Technologies is one of the early
pioneers of electronic data capture for drug research.
ALPHADAS and Smart Patient Diary Card use Internet,
smart card, and hand-held technologies, providing highquality and regulatory-compliant solutions. Additionally,
recruitment, study scheduling, laboratory and data
management tools provide both sponsor and site with a
fully integrated solution.
MAJARO InfoSystems Inc.
ClinAccess SureStart See Data Collection and Management
Mini Mitter Co.
Actiwatch Actigraphy Monitors Actiwatches are wristworn, 17.5-g medical devices for monitoring subject activity and analyzing sleep and circadian rhythm patterns.
Used for supplementing patient diaries with objective
data, verifying subject compliance with trials protocol, and
tracking treatment efficacy. Actiwatch-Score includes an
LED touchpad for patient input of subjective rating on pain
levels, anxiety, etc.
NetRegulus
ActivityExpert ActivityExpert is an entirely Web-based
solution that enables any authorized person to input information into NetRegulus’ PQIntelligence Software System.
This product is ideal for vendors, field representatives,
auditors, clinical trial personnel, and others who require
limited access to the system’s functionality. Available in
both online and offline versions for increased productivity
and mobility.
Phase Forward Incorporated
InForm Phase Forward’s flagship solution is the InForm
software product, using Internet technologies for
electronic data capture (EDC) to conduct and manage
clinical trials efficiently and effectively. The InForm
solution covers all operational functions of a clinical data
management system in a user-friendly, Web browserbased interface that puts all information just a click away.
our consultants including protocol and paper case report
form design (includes layout, development of validation
criteria, documentation and testing). Typical project
requires between 40 and 160 hours of consultancy.
Systemsmith
Services See Custom Application Development
Knowledge Management
Aris Global
REGISTER See Data Collection and Management
BBK Healthcare, Inc.
TrialCentral.net TrialCentralNet is BBK’s e-process
management system for maximizing site enrollment
capability through the creation of relationships with clinical study sites. The comprehensive suite of Web-based
tools includes modules specific to sponsors, sites and
BBK. Providing ongoing data and communications access
in real-time, TrialCentralNet creates a “virtual community”
among key parties and maximizes productivity.
BioObjects, Inc.
Web Services See Web-Based Software Services
Aris Global
Aris Global E2B Gateway E2B Gateway is the only
Insightful
electronic safety submissions software certified by
Cyclone Commerce to operate with the EMEA. Designed
as a stand-alone application, E2B Gateway facilitates the
transfer and management of E2B/M2 files to regulatory
authorities and trading partners. E2B Gateway can be
configured to work with ANY pharmacovigilance system.
InFact InFact is currently the only commercial technology
Cardiff Software, Inc.
CoreDossier CoreDossier lets you easily and efficiently
LiquidOffice See Electronic Data Capture
manage multiple, simultaneous report and submission
dossiers. The backbone of this product suite is its unparalleled PDF-rendering technology, which ensures that exact
page fidelity is maintained at all times. With a single,
cohesive interface, it works with no modification on most
document management systems.
Datafarm Inc.
Clinical Information Technology Consulting Datafarm
provides electronic document publishing, clinical data
management, statistical analysis and reporting, document
management systems and custom application development solutions. Functionally, Datafarm solutions maximize
the quality of publishing and efficiency of document lifecycle management.
eOriginal Inc.
eOriginal eCore Business Suite 2.0 See Document
Management
Galt Associates, Inc.
dsGateway and dsNavigator dsGateway: Proven online
of its kind to embody human-like intelligence, thereby
empowering knowledge workers and decision-makers to
make better decisions faster in a wide range of critical,
high-value business areas.
Liquent, Inc.
NetRegulus
PQIntelligence PQIntelligence is a 21 CFR Part 11-compliant software suite that provides enterprise-wide, Webenabled data management specifically for the medical
products industry. Working in the background, PQIntelligence organizes, automates, and manages clinical,
regulatory, and other product quality data, while you focus
on what you do best—developing and marketing your
product.
secure electronic submission. dsNavigator: The industry
standard coding and dictionary management solution
Premier Research/SCP Communications
Gupta Programming
specific Web page that is a password-protected central
repository of all study information and CRFs for your study.
Why does this technology make a difference to you? (1)
Because it’s Web based, CRF data can be viewed on a
real-time basis. (2) Because it’s Web based, sponsors and
investigators can access all or parts of study-related information (e.g., subject status and study documents)
whenever they choose. (3) Pre-screening data on an
ongoing basis saves CRAs valuable time during site visits
while allowing sponsors to make protocol revisions as
necessary.
Best Practices Clinical Trial Reporting Templates
Expedite and standardize new development based on prebuilt and validated best practices clinical trial reporting
templates. Reuse and customize best practices templates
to individual clinical trial studies. Ideal environment for
leveraging and reusing existing SAS code. Ensure compliance by using best practices SOP and validation documentation for IQ and OQ requirements.
MAJARO InfoSystems Inc.
ClinAccess Web See Data Collection and Management
Premier Web Portal The Premier Web Portal is a protocol-
StudyBuilder Limited
StudyBuilder Enterprise Edition ($4999/study designer;
no site/subject/data manager fees) Integrated study
design, data management and collection software
package. Use wizards and drag-and-drop to design and
deploy your study. Includes data collection/management
system for Web, palmtop, and desktop computers and
integrates data from spirometers, etc. automatically.
Advanced Systems Development
Clinical IT systems implementation consulting
Implementation and integration consulting services for
Oracle Clinical, TMS, AERS and other IT clinical systems.
Cetan Technologies
Symfo
Medical Imaging
IT Consulting
Cardio Control
Cardio Perfect PC-based resting ECG system. Includes
management of data. Optional software for digital transmission, Interpretive statements, QT/JT dispersion, HRV.
Will have FDA-XML output once defined by FDA.
KIKA Medical
Symfo Electronic Diary Electronic handheld patient
Computer Systems Validation Consulting Services See
diaries for recording symptoms, activities, medication
intake, etc.
Validation
Eventa See Web-Based Software Services
Datafarm Inc.
Perceptive Informatics
Target Health Inc.
Clinical Information Technology Consulting See
Target e*CRF Target e*CRF is a proprietary Internet-based
Electronic Submissions
remote data entry, data management and project management system, created and managed exclusively by Target
Health Inc. Data are entered through a Web interface
(browser) directly to a remote database. No software is
installed ,and the system is fully functional even if used
with a 28.8 modem.
Perceptive Informatics
TEAMworks Clinical Services
TRIALink EDC Systems TEAMworks was founded in 1997
following successful introduction of our Internet-based
TRIALink electronic data capture (EDC) system. The
TEAMworks organization has since established itself as a
Services See IT Consulting
Statistical Analysis
Statistical Analysis
Services Perceptive Informatics, Inc. develops and offers
a portfolio of sophisticated and innovative technologybased products and services that facilitate clinical product
development and decrease time to peak sales. The
technology portfolio includes Web-based solutions, Interactive voice response systems, electronic data capture,
and medical imaging solutions.
StudyBuilder Limited
StudyBuilder Design Consultancy Outsource study design
and implementation based on StudyBuilder products to
Analyse-it Software, Ltd.
Analyse-it Clinical Laboratory Analyse-it! Method validation and evaluation software for Microsoft Excel. Includes
NCCLS and IFCC protocols, Altman-Bland and NCCLS biasplots, Deming, Passing-Bablok and Kappa method
comparisons, NCCLS EP5 imprecision, NCCLS EP6 linearity, IFCC reference ranges, ROC curves, and sensitivity
and specificity analysis. Visit our Web site to download a
free trial.
ClinSource
28
APPLIED CLINICAL TRIALS SUPPLEMENT
actmagazine.com
August 2002
TrialXS/PDR TrialXS/PDR is the Online Patient Data
Review application for reporting and exporting Clinical Trial
Data, containing statistical tools and automated data
verification. It is an online data review application for fast,
accurate and secure handling of your study data.
TrialXS/PDR is designed to speed up the data review
process in your clinical trials.
Cytel Software Corp.
EaSt Software for the flexible design of clinical trials,
ClinLogic
ProIRB Plus, Inc.
ClinProject See Clinical Project Management
PRO_IRB PRO_IRB is a multi-User, multi-IRB software
application providing productivity and compliance assurance tools for managing the institutional review board
work-flow process from scheduling to meeting minutes.
The application is developed in MS Access and is
currently in use by major universities and healthcare institutions nationwide.
ClinSite ClinSite is a comprehensive solution for SMOs
and research sites, managing all aspects of clinical trial
participation from prospecting and enrollment to grant
payments and patient stipends. The system tracks visits
and procedures and can enforce protocol visit windows.
ClinSite also includes call center management, media
effectiveness, and medical records.
Propack Data Corp.
including early stopping, midstream sample size adjustment, and interim monitoring.
ClinSource
DataSpectrum
Trial Management System For Your Clinical Research
Community. To plan, conduct and effectively manage clinical trials through experience, collaboration, and consistent workflow. The TrialXS Trial Management System (TMS)
addresses the global management aspects of the entire
clinical research process.
SiteWorks Solutions
CTIS Inc.
SiteMinder Web-based financial, regulatory and adminis-
Services See Data Collection and Management
DZS Software Solutions, Inc.
ClinPlus NDA DZS Software Solutions is the leader in
SAS-based software solutions for Clinical Data Management and Reporting. The ClinPlus family of products
enable your company to meet its goals in a timely and
cost effective manner.
PMX CTM Solution The CTM solution fulfills the specific
TrialXS/TMS TrialXS/TMS is the integrated Web-based
TrialBridge Clinical trials research and management
Gupta Programming
solution.
Best Practices Clinical Trial Reporting Templates See
FW Pharma Systems
Electronic Submissions
IMPACT IMPACT is a comprehensive, single, integrated
database for managing clinical research activities, ranging
in scale from single-site to large multinational, multisite
studies. It provides a route to a wealth of management
control techniques such as control by key performance
indicators.
MAJARO InfoSystems Inc.
ClinAccess Web See Data Collection and Management
Pharsight Corporation
Pharsight Trial Simulator Simulation-based clinical trial
design and optimization.
Resampling Stats, Inc.
Resampling Stats Software Resampling Stats uses the
new statistics of resampling (including bootstrapping and
permutation). Resampling is excellent for confidence intervals, hypothesis tests, and assessing errors in estimates
used to determine reliability of conclusions drawn from
small samples. Resampling Stats’ easy-to-use programming language lets you design resampling procedures with
your data.
Stat-Ease, Inc.
Design-Ease Software Design-Ease is an entry-level
program for design and analysis of two-level factorial
screening experiments. Detect main effects and interactions that lead to breakthrough improvements. In addition,
the software handles any number of categorical factors at
any number of levels, thus offering extreme flexibility for
most screening needs.
Synergy Software
KaleidaGraph See Data Mining/Visualization
Training
ePharmaLearning
eMeetings, eLearning On-line meetings, eLearning and
eCollaboration solutions for clinical research professionals delivered by clinical research professionals.
StudyBuilder Limited
ICTI
Interactive Trial Management Solutions See Clinical
Project Management
Study Assistant iMedRis has designed a Web-based trials
management system that integrates with our Web-based
IRB application. Submissions, AEs, and updates all flow
seamlessly between each of the modules thus cutting
time and paperwork for all. Sites also have ability to
capture and export data using our new Data Capture
module.
InfoPro Solutions
Clinicopia Suite The Clinicopia Suite is the world’s first
purpose-built, industry-specific clinical trials supplies
management system developed from the ground up to
meet the unique needs and concerns of all the groups
associated with clinical trial materials supply. The Suite
consists of Clinicopia Supply Chain, Clinicopia Labeling,
and Clinicopia Forecasting.
Invantage, Inc.
Investigator DataWeb System Invantage’s Investigator
Dataweb is a unified Web-based repository and decision
support environment for corporatewide collaboration and
proprietary knowledge management regarding large
numbers of potential investigators. Using a personalized
Web interface, sponsors access and analyze potential
investigator data, producing highly informed and confident
decisions regarding effective trial placement.
NetRegulus
Complete Introduction to StudyBuilder Training Course
($499/CD-ROM, DVD, video) An interactive multimedia
guide to using StudyBuilder tools for study design, data
collection and management.
StudyExpert StudyExpert streamlines the management of
clinical trial and other study data, while complying with the
FDA’s Guidance for Industry: Computerized Systems Used
in Clinical Trials and 21 CFR Part 11. Features intuitive
tools to enter, track, verify, query, view and export case
report from data as well as input and oversee key
management information.
Validation Wizard for Application User Teams See Validation
Trials Management and Administration
Advanced Clinical Software
Study Manager Study Manager makes the process of
conducting studies more efficient, more organized, and
more profitable. It lets research administrators manage
operations and financials, while making daily work easier
and more organized for clinical staff. Now entirely Webbased, Study Manager is in its ninth year, with over 1200
installations worldwide.
Advanced Systems Development
Clinical IT systems implementation consulting See IT
Consulting
Analyse-it Software, Ltd.
Analyse-it Clinical Laboratory See Statistical Analysis
Assured Information Systems
Oriam
EC1-TrialManager Administrative, financial clinical trials
management, including tracking of milestones, essential
documents, drug supplies, sites, patient visits and procedures, budgeting and payments. Integration of SOPs
(check-list module). Off-line modules (portable and
wireless). Database query (query module). Web-enable
(site and patient levels). Standard API (planning, IVRS,
data management, finances, logistics, etc.). Audit trail (21
CFR compliant).
PerMedics, Inc.
Surveyor Surveyor is a software application designed
specifically for single- and multisite clinical trials management. Surveyor tracks trial progress including enrollments,
scheduling, resource management, financials and IRB
tracking. Patient tracking tools include automated
scheduling, screening, adverse events and activity
reports. The Web-based software aids HIPAA compliance
and simplifies trial management.
PV-Works See Adverse Events
PharmaTech Solutions
ClinicalTrialsNet Inc.
Services See Clinical Project Management
ClinTriNet See Electronic Data Capture
August 2002
trative management application. Fully integrated, configurable system including budgeting, financial tracking,
regulatory administration and patient scheduling and
recruiting.
TrialMinder Web-based trial management application
designed for study and financial management, site activation, and document tracking. Provides investigator registry
information, investigator payment tracking, document
tracking, regulatory management, budgeting, and reporting capabilities.
StudyBuilder Limited
Complete Introduction to StudyBuilder Training Course
See Training
iMedRIS Data Corp.
Complete Introduction to StudyBuilder Training Course
Validation Wizards International
requirements of the pharmaceutical industry. CTM stands
for the organization of the complete material and information flow: the production of the substances, randomization, packaging to the delivery, batch tracing and surveillance of the expiry and retest date of the trial samples at
the clinical centers.
TrialTrac, Inc.
SiteTrac SiteTrac is clinical trials management software
tailored to the needs of SMOs, research institutions,
sites, and AROs. It’s easy to use, quick to implement, and
customizable. Our integrated design is comprehensive,
and tracking includes patient information, essential
documents, investigator earnings and sponsor payments,
patient/study searching, and every step in between.
TrialWorks TrialWorks is clinical trials management
software designed for sponsors and CROs. It's easy to
use, quick to implement, customizable, and 21 CFR 11
compliant. Our integrated design is comprehensive, and
tracking includes investigator payments and earnings,
patient information, essential documents, clinical supply
inventory, and every step in between. TrialWorks is also
available through our e-Service—we are your ASP.
Velos, Inc.
Velos eResearch Velos eResearch is a transformational
trial management solution that supports investigators,
study teams and sponsors through the entire research
process—including protocol design, patient feasibility
assessment, study administration, project management
and trial execution—-thus expediting the research
process, enhancing quality and improving access to data
by integrating systems, aggregating information and
centralizing processes.
Winchester Business Systems, Inc.
Protocol Manager Protocol Manager is a software suite
that helps an entire trial team (sponsor, CRO, SMO, site,
investigator, and CRA) manage all documents for clinical
trials—all investigator documents, protocol documents,
inventory, SOPs, patient recruiting, patient scheduling and
patient tracking. It includes a Snapshot module that
details summary trial status. 21 CFR Part 11 compliant.
Validation
Cetan Technologies
Computer systems validation consulting services Cetan
provides specialized computer systems validation (CSV)
services for the pharmaceutical, biotechnology, and
medical device industries. Our test suites are designed to
determine the accuracy and reliability of each computer
system function using a practical, defensible approach.
We also specialize in 21 CFR Part 11 assessments, SOP
development and remediation.
Drumbeat Dimensions, Inc.
Dynamic DRUMBEAT for Clinical Trials Supplies (CTS)
See Document Management
Honeywell/POMS
POMS CMS See Other Applications
SEC Associates, Inc.
Computer system compliance consulting SEC Associates
actmagazine.com
APPLIED CLINICAL TRIALS SUPPLEMENT
29
provides system compliance consulting and computer
validation services for the pharmaceutical, biotechnology,
and medical device industries. SEC’s experienced consultants assist clients with regulatory compliance assessments, vendor audits, 21 CFR 11 training, procedure
development, requirements analysis and planning,
documentation, and execution of computer validation and
life cycle activities.
IntraLinks, Inc.
Validation Wizards International
KIKA Medical
Validation Wizard for Application User Teams Validation
Eventa Eventa technology allows the development of
Wizard for Application User Teams is a “read-and-click”
application that trains the trainer and the user team in the
ABCs of computer systems validation (CSV) for user
acceptance of regulated systems. Wizard teaches a
common-sense approach for integrating CSV into the
normal workflow of regulated areas.
customized Web-based applications dedicated to the
management of studies and registries.
Fisher Clinical Services
LifeTree Technology, LLC
Clinical Materials Supply Chain Management Services
LifeTree ICTM See Electronic Data Capture
Premier Web Portal See Knowledge Management
Services include design, manufacturing, packaging, labeling, storage, distribution, site management including
patient randomization and kit assignment, return processing and drug destruction. We utilize the latest technology
within cGMP facilities managing your projects with experienced teams.
Web-Based Software
can then run shared analytical models, view custom
reports, and generate graphics from a familiar environment, such as a Web browser or Excel.
IntraLinks digital workspaces See Document Mgmt.
iMedRIS Data Corp.
Study Assistant See Trials Management/Administration
Logos Technologies Ltd.
ALPHADAS See Electronic Data Capture
Premier Research/SCP Communications
Other Applications
CB Technologies, Inc.
MetaTrial See Electronic Data Capture
DZS Software Solutions, Inc.
ClinPlus Coding DZS Software Solutions is the leader in
SAS-based software solutions for Clinical Data Management and Reporting. The ClinPlus family of products
enables your company to meet its goals in a timely and
cost effective manner.
Propack Data Corp.
Honeywell/POMS
QuickZilver Innovative Web-based process modeling
PMX CTM Solution See Trials Management/Administra-
software utilized for improved organization and ISO certification and documentation.
tion
POMS CMS Manufacturing execution systems for clinical
supplies manufacturing.
SiteWorks Solutions
SEC Associates, Inc.
PDF Form Services See Document Management
SiteMinder See Trials Management/Administration
Computer system compliance consulting See Validation
BioObjects, Inc.
TrialMinder See Trials Management/Administration
Synergy Software
Web Services BioObjects specializes in enterprise
StudyBuilder Limited
business and data solutions. This includes: portal design
and development using Web services; data integration;
e-procurement and supply chain managements; and
staffing and workforce management.
StudyBuilder Enterprise Edition See Electronic Data
KaleidaGraph VersaTerm-Pro is a broad-based communications application combining high-quality, industry
standard terminal emulations and a suite of network
connections. Terminal emulations include: DEC
VT100/VT220, Data General’s D210/D211, both with
multiple sessions.
AlQemy
Capture
Velos, Inc.
Velos eResearch See Trials Management/Administration
DZS Software Solutions, Inc.
ClinPlus Remote DZS Software Solutions is the leader in
SAS-based software solutions for Clinical Data Management and Reporting. The ClinPlus family of products
enable your company to meet its goals in a timely and
cost effective manner.
ePharmaLearning
eMeetings, eLearning See Training
Galt Associates, Inc.
dsGateway and dsNavigator See Electronic Submissions
Winchester Business Systems, Inc.
Wireless/Mobile Technologies
ArcStream Solutions
Services ArcStream is a wireless and mobile systems
integration firm focused on developing solutions for the
mobile professional.
Carevoyance Telematics
Health Agency Tracking The Health Agency Tracking
system tracks all documents associated with queries and
responses made by and to regulatory agencies. Automatic
workflow notifies all interested parties and initiates action
items for resolution of the query. Maintains complete
audit trail. Conforms to 21 CFR Part 11 regulations for
electonic records and signatures.
Catalyst See Electronic Data Capture
Logos Technologies Ltd.
Insightful
StatServer StatServer is a Web-based decision support
system based on S-PLUS, the premier tool for data analysis, data mining, and statistical modeling. It enables
analysts to deploy analytical tools to decision makers who
SMART Patient Diary Card See Electronic Data Capture
NetRegulus
ActivityExpert See Electronic Data Capture
The 2003 Applied Clinical
Trials EDC & Software
Application Supplement will
For more information contact:
Wayne K. Blow
be polybagged with the March
PUBLISHER
2003 issue, to be distributed
Raritan Plaza III, 101 Fieldcrest Avenue, Edison, NJ
08837-3622, USA
+1 (732) 346-3021 fax: +1 (732) 225-0211
at the DIA’s 18th Annual
Gillian Brailsford
Workshop for Clinical Data
Management, March 30–April 2, 2003,
Philadelphia Marriott Hotel,
Philadelphia, Pennsylvania.
EUROPEAN SALES MANAGER
Advanstar House, Park West, Sealand Road, Chester
CH1 4RN, UK
+44 (1244) 393 104 fax: +44 (1244) 376 130
John Kiesewetter
WESTERN SALES MANAGER
859 Willamette Street, Eugene,
OR 97401-6806, USA
+1 (541) 338-0022 fax: +1 (541) 338-0044
30
APPLIED CLINICAL TRIALS SUPPLEMENT
actmagazine.com
August 2002

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