
Proof of Concept in osteeorathritis OA
Date: April 11, 2015
Service Description
Study design in OA patients after 14 treatment with a new oral analgesic
What Went Well
Parexel was procative to find solution to keep costs down while esuring data quality. Quality means interpretable results since this was a Proof of Concept trial. Pors and cons of different options were disclosed to allow optimal decision
What Could Be Improved
Nothing the CRO was proactive Provide a tentative study design in due time Alowing discussion and optimization of the study protocol
Lessons Learned from the Experience
The CRO suggested to conduct the study in a particula centre to monitro safety issues understaning how importan was safety to assess the value of the product. Provided evidence of greath experience in this field