Service Description

The CRO was contracted to perform a relative bioavailability study. This included protocol preparation and running of the clinical study in healthy volunteers. The CRO was also contracted to produce the clinical study report at the end of the study.

What Went Well

Parexel were proactive in the conduct of the study, keeping the team informed of progress. For the reporting they were able to produce a first draft without too much direction from the team. They were also able to produce the clinical study report in line with agreed timelines.

What Could Be Improved

The first draft of the CSR delivered was substandard and was not suitable for general team review. There were typographical errors and it was not consistent with the company style guide. There was also an error in the drug name which was repeated in a number of places.

Lessons Learned from the Experience

The CRO was able to address the identified issues with the first draft CSR in a very short timeframe so that the overall timelines were not impacted. They were also able to address team review comments in an appropriate manner. They were flexible enough to make amendments to sections that had been delivered by other vendors.