Protocol Consultation Helps Sponsor Exceed Asthma Study Enrollment Goals

Case Study #4

Protocol Consultation

Challenge

We were approached by a large pharmaceutical sponsor in need of consultation to rework their protocol for a Phase II asthma study. They needed twenty participants over two sites in a two month period to meet criteria on time for FDA submission. The sponsor has worked with Vitalink in the past and trusted our network and resources to accomplish the job on time with accuracy and reliability.

Solution

VitaLink key opinion leaders aided in rewriting and simplifying the sponsor’s study protocol to make it more user friendly and meet criteria for FDA submission. We were able to enroll 100% of the subjects needed in only 2 weeks, saving the client significant time and energy while streamlining their enrollment and submission process.

Outcome

The sponsor was able to meet all FDA submission timelines, keeping them on schedule for Phase III testing. Thanks to Vitalink’s expedited enrollment and simplification of protocol, the drug was approved without delay and able to move to market faster than anticipated.

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