Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.
Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.
The purpose of this whitepaper is to define a Rescue Study, outline the basic assumptions, including risks, in setting up such a trial based on DATATRAK’s prior experiences, and present the actions that can help avoid or mitigate these risks during a deployment.
|
|
|
|
|
|
|
|
|