Clients:
University of Pennsylvania Weight and Eating Disorders
Program
VIPS
Client : University of Pennsylvania Weight and Eating Disorders
Program - Clinical Trials Database
Business Issue :
The Weight and Eating Disorders Program at the University of Pennsylvania
School of Medicine engaged BroadBase Solutions, Inc. to develop a Clinical
Trials Database Application. The University needed a robust scalable
application for a study on the much talked about Atkins diet. The study will
run for 5 years and include multiple sites and a diverse population.
The application encompasses several modules: an Administration Module to add and
edit user rights, sychronize data from multiple sites, and the ability to
create new groups that participants can be assigned to, a Billing System that
tracks payment and refunding for each participant, a Data Entry Clinical Forms
Module that allows data to be entered for 30+ forms, a Scheduling Module that
allows the user to view the schedule of the site, study, or participant over a
selectable time period, and a robust Reporting Module with the ability to
search on multiple criteria across all sites.
Solution :
BroadBase Solutions designed and developed a real time custom Clinical Trials
Database Application that has individual modules, which can be reused for
additional studies. BroadBase leveraged its knowledge of Clinical Trials and
FDA regulations, (CFR 21 Part 11) to systematically manage data and provide QA
checks in a validated system.
Result :
The University has a custom built validated Clinical Trials Database that meets
their specific needs and provided robust reporting capabilities. Developing the
modules independently gives the University the ability to reuse them for other
studies.
Development Tools :
Visual Basic, COM, ASP, VBScript, JavaScript, DHTML, HTML, Crystal Reports and
SQL Server.
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Client :VIPS - QA Validated Testing
Business Issue :
VIPS, Inc., formerly CB Technologies was revamping their Electronic Data
Capture, (EDC) product for a new release. VIPS did not have enough experienced
software testers with FDA auditing and regulations experience. BroadBase
Solutions provided several QA testers to augment VIPS staff.
Solution :
BroadBase Solutions provided several QA testers to augment VIPS staff.
Responsibilities included: creating and executing test plans, perform Unit,
Functional, Integration, Perfomance, and Regression test scripts, preparing
documentation to comply with FDA auditing, perform complex testing tasks on
Windows applications developed using Visual Basic, ASP, and .Net in accordance
with CFR 21 Part 11.
Result :
VIPS was able to successfully complete and roll out the newest validated
version of their EDC system on time.
Development Tools :
Mercury Interactive, Test Director, MS Excel, Access and Visual SourceSafe
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