EXPEDITED CLINICAL TRIALS - FAST START UP
A large, multi-national Sponsor called Krescent to replace a site that dropped out of a study, and required that Krescent be prepared to start screening study subjects within 1 month of the initial conversation. This case study outlines the challenges we faced and the solutions we put in place to successfully meet their very aggressive and short timelines.
CHALLENGE
Krescent sites often function as study sites for multinational Sponsors/CROs. As such, a Sponsor we often work with approached Krescent with a special request; to start screening patients outlined as per study I/E criteria for trial with just a 3 week lead time.
The site that was originally not contracted for study as sponsor have their own site database, upon some time passed, and the sponsor turned to Krescent for study rescue, as a trusted partner, to pick up and complete the study within the limited timelines and budget.
SOLUTION – 3 FACTORS FOR SUCCESS
Flexible Team:
The study team quickly prioritized this project to focus on the submission and clearance.
The Clinical Coordinator Team created the patient documents in 1 day.
The Project Management Team built a tight schedule with the Sponsor to get approved documents to the IRB in just 8 days (typically a 2 week process)
Efficient Process:
The Study Team led preparations to complete the Site Initiation Visit (SIV) and start screening within 2 weeks.
Experienced Clinical Study Site Staff:
The large team of experienced staff were critical in the success of this endeavor. Without the highly experienced and dedicated team that Krescent has in place, it would not have been possible to jump start this study so quickly.
OUTCOME
Krescent exceeded the Sponsor’s expectations, getting the study started in less than 1 month, and completed the study before timeline.
