StudyTeamTM Drives Early Protocol Amendment, Accelerates Enrollment for Top-10 Sponsor

Sponsor knew, with confidence, which protocol amendments would accelerate enrollment 

600 patients

worth of data amassed in just 6 weeks.

The Sponsor


A top-10 sponsor conducting a Phase 3 trial with more than 300 sites. Trial completion was gating NDA submission, and enrollment was forecasted to take two years. Successful enrollment was paramount.

The Challenge

With many sites and a long enrollment period, the Sponsor needed upfront visibility into any factors that may be unnecessarily slowing enrollment.

The Sponsor had limited insight into potential enrollment issues. They were not able to see which inclusion/exclusion criteria was leading to pre-screen failures, and were not able to track the impact of any protocol amendments.


The Solution

By deploying StudyTeamTM across their sites, the Sponsor’s clinical operations team was able to amass 600 patients worth of data in just 6 weeks.

StudyTeam automatically shares detailed, de-identified data from the sites with the sponsors in real time. This data includes pre-screen and screen failure reasons, and reporting on the inclusion/exclusion criteria. The team discovered that just a few of the criteria were causing the majority of pre-screen failures. 42% of patients had pre-screen failed due to inclusion criteria #4 and 19% failed due to inclusion criteria #7.



Real-time pre-screening analytics inform protocol amendments that make a difference

After careful analysis, the Sponsor determined that relaxing inclusion criteria #4, would not materially impact the study’s objectives. The team issued a protocol amendment. 

All of the patients who pre-screen failed were still in StudyTeam. After the protocol amendment, the clinical teams were able to find and revisit those patients, accelerate enrollment, and dramatically exceed their timeline goals for this critical path study.

Using StudyTeam’s protocol amendment impact analysis report, the Sponsor was able to measure the impact of their actions on enrollment and see which inclusion/exclusion criteria amendments would further accelerate enrollment. This data also helped them with their future protocol designs. 

Key software features

Patient Log Tracking 

Sites automatically share de-identified pre-screen and screen failure reasons with the sponsor to more quickly identify any barriers to enrollment.

Inclusion / Exclusion Criteria Analysis 

Sponsors can isolate which criteria are causing the most pre-screen and screen failures, and which changes would have the greatest impact on enrollment.

Protocol Amendment Impact Analysis 

Once a protocol amendment has been implemented, sponsors can measure its impact and use that information to guide future protocol designs.


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