Service Description

We were in search of potential biomarkers to be used in the POC study in RA patients that were linked to the mechanism of action of our drug to assess both safety and efficacy

What Went Well

Parexel identified the area of interest and provided an In Vitro program to screen potential BM to be used in the clinical trial. They were were very proactive and demonstrated to understand our needs providing support and consultation as well.

What Could Be Improved

We were pretty much satisfied with the performance of Parexel. We were actually the rate limiting factor in providing them with the available data to be used for the development of the In Vitro plan.

Lessons Learned from the Experience

It is extremely important to rely on an experienced CRO during early development if indication, and or BM are not known. The CRO must have global reach to provide patients and lab support for the preliminary investigations.