Clinical Compliance as a Service

USDM provides turn-key solution that reduces clinical study time and study cost

The Situation

A global pharmaceutical company with $16B in revenue
Customer 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
CDM team needed a turn-key solution that would reduce the effort required by staff to support study start-up UAT of these systems
The customer also wanted to reduce the impact of additional resources onsite, and have access to a pretrained pool of candidates available on-demand to support peak periods

The Solution

USDM was engaged for three years to provide a managed service solution to support CDM for EDC/IRT/ePRO UAT
USDM assigned a team of customer approved and trained consultants with customer-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 off-site documentation and on-site 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 startup and changes support for EDC, ePRO and IRT

Efficiencies created:

Reduced Study Startup Time

$10,000 saved per study with EDC UAT

$90,683 total savings for EDC UAT project