Program Transition

Rescue Study

Program Transition


ISSUE



Project rescue required due to prior CRO under performance and lack of experience to drive and achieve recruitment and enrollment goals

SPONSOR

A leading global biopharmaceutical company.

PROJECT

North American component of a 3-proto-col, phase 3 program involving 160 sites and 600 patients.

CHALLENGE

– Research naïve, under-performing sites

– Complicated enrollment requirements

– High staff turnover rate on Sponsor study team

– Sponsor-driven scope change within first 3 months that involved:

– 35% increase in sites

– 28% increase in patient recruitment goals

SOLUTIONS

ProTrials built a robust transition plan for the outgo-ing CRO (as approved by the sponsor)

– Given our experience with study transitions, we had established tools, processes and leadership to address the specific needs

– Employed site-specific recruitment boosting tactics to ensure enrollment targets were met, e.g. ProTrials assistance with referral follow up, conduit between sites and recruitment vendor

– Established accountability by assigning a role of Recruitment Specialist

– Increased CRA responsiveness to site queries and challenges strengthened CRA-site relationships that led to sites meeting or exceeding study deliverable

RESULTS

– Achieved 98%+ SDV rate two months in advance of client’s target

– Maintained 97%+ data entry rates across the program

– Visit report compliance in 2019 was 97%+ (with >800 VRs completed)

– ProTrials continues to build robust “Les-sons Learned” and “Best Practices” guid-ance documents that are shared with all transition study teams on an ongoing basis

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