USDM provides a turn-key solution that reduces clinical study time and study cost
Learn how USDM delivered a managed service solution to a global pharmaceutical company to support Clinical Data Management (CDM) across myriad systems. No longer is this $16B company plagued by the increasingly steep costs of inefficient clinical study practices.
The Challenge
A global pharmaceutical company with $16B in revenue was running 40-50 studies per year and struggling with the time and cost of User Acceptance Testing (UAT) for its Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient Reported Outcome (ePRO) systems.
- The 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 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.
- Inefficient study practices were driving up cost and lengthening timelines, with study startup for CDM systems taking 3-4 months and database lock stretching to 40 days.
Because EDC, IRT, and ePRO systems handle regulated clinical data, every validation and change-control activity had to hold up to 21 CFR Part 11 compliance scrutiny while protecting data integrity across dozens of concurrent studies.
The Approach
USDM was engaged for three years to provide a managed service solution supporting CDM for EDC/IRT/ePRO UAT. The model combined off-site documentation with on-site test execution and was built to flex with the customer's study calendar.
- USDM assigned a team of customer-approved and trained consultants, equipped with customer-provided laptops, available to support testing.
- Monthly planning meetings allocated resources and planned for upcoming new studies and changes; emergency changes were also accommodated.
- Ongoing KPIs were monitored and reported to leadership.
Scope of work
- User Acceptance Testing, Change Control, and Validation of the Standards Library.
- A harmonization and standardization phase to validate the core IRT system and create a validated EDC library of standardized case report forms and edit checks for reuse across multiple studies.
- Ongoing study startup and change support for EDC, ePRO, and IRT.
USDM applied a risk-based, Computer Software Assurance (CSA) mindset to focus testing effort where it mattered most, and delivered the work as part of a broader continuous compliance program so validated standards stayed audit-ready between studies.
The Results
The managed service produced measurable, repeatable efficiency gains across every CDM system in scope:
- Reduced average EDC UAT time from 110 hours to 24 hours.
- Reduced IRT UAT from 5-10 days to 1-2 days.
- Reduced database lock time from 40 days to 14 days.
- Reduced study startup for CDM systems from 3-4 months to 1 month.
Those time savings translated directly into cost savings:
- Reduced study startup time across the program.
- $10,000 saved per study on EDC UAT.
- $90,683 in total savings for the EDC UAT project.
By converting a costly, resource-heavy testing burden into a predictable, KPI-driven managed service, USDM gave the customer a scalable on-demand team and a validated standards library that keeps clinical studies moving and continuously compliant. Talk to USDM about applying the same model to your EDC, IRT, and ePRO programs.