Leveraging Standardized SOPs to Exceed Enrollment Goals

Case Study #1

Subject Enrollment

Challenge

VitaLink was approached by a new sponsor in need of testing for a COPD study. They required 70 participants across 4 sites- 2 to host 60 participants in the US and 2 more for 10 participants in the UK. We had approximately 3 months to organize and complete testing.

Solution

Two testing sites with identical SOPs were offered in the US and the sponsor chose to complete testing in only one to balance risk- both sites agreed to provide 30 patients over the 3 month period. To ensure deadlines were met with ease, we pre-planned 40 subjects to allow for the confirmed 30 to enroll in the timeframe requested. Thanks to our single point of contact, we were able to work closely with the sponsor to itemize operational items needed for the study.

Outcome

Even though we had to work with non-VitaLink sites for this particular study, we were still able to complete the study in the timeframe requested and provided 10 additional subjects to compensate for underperforming sites outside of our network.

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