Clinical Compliance as a Service

A global pharmaceutical company with $16B in revenue was plagued by increasingly steep costs associated with inefficient clinical study practices. USDM delivered a managed service solution to support Clinical Data Management (CDM) for myriad systems.

The Situation

A global pharmaceutical company with $16B in revenue
Client had 40-50 studies per year and was seeking to reduce study time and study costs of User Acceptance Testing (UAT) for their Electronic Data Capture (EDC), Interactive Response Technology (IRT) and Electronic Patient Reports Outcome (ePRO) systems
Clinical Data Management team needed a turn-key solution that would reduce the effort required by staff to support study start up UAT of these systems
Additionally, client wanted to reduce the impact of additional resources onsite, and have access to a pre-trained pool of candidates available as needed to support peak periods

The Solution

USDM was engaged for three years to provide a managed service solution to support Clinical Data Management (CDM) for EDC/IRT/EPRO UAT.
USDM assigned a team of client approved and trained consultants with client provided laptops that were available to support testing.
Monthly planning meetings allocated resources and planned for upcoming new studies and changes. Emergency changes were also accommodated.
Managed service included offsite documentation and onsite test execution.
Ongoing KPIs were monitored and reported to leadership.
The scope of the work included:
- User Acceptance Testing, Change Control and Validation of Standards Library.
- Harmonization/Standardization Phase to validate core IRT system and create a validated EDC library of standardized case report forms and edit checks to be used across multiple studies.
- Ongoing study start-up and changes support for EDC, ePRO and IRT.

Efficencies created:

Reduced Study Startup Time

$10,000 saved per study with EDC UAT

$90,683 total savings for EDC UAT project