The collection of high-quality endpoint data was paramount to the success of this Phase II program. Because this was the first clinical trial ever done for this disease, it was necessary to develop non- disease-specific clinical assessments, in collaboration with Key Opinion Leaders (KOLs), for use as endpoints. The newness of these tools presented challenges to site selection and training, as well as risks to uniformity in patient recruitment and consistency in data collection.
IIT Program Management Case Study
6+ year relationship with a large biopharma company that needed to change the operating model for their investigator-initiated trials (IIT), in part…
PRA Successfully Delivers A Complex Phase I Psoriasis Study
Exceptional Support and Innovative Strategies Combat Study Challenges.
Strategies for Accelerating Rare Disease Clinical Development
Rare disease trials differ from those in most other therapeutic areas because the indications are more complex and involve smaller patient…