Service Description

Parexel was contracted to conduct a Phase 1 device comparison/PK study. The contract was full service. The Phase 1 study was conducted in their Baltimore, Maryland clinic.

What Went Well

The CRO conducted the clinical aspect of the study very well. The staff was professional, competent and thorough. From the recruitment through the study conduct, the product was very good.

What Could Be Improved

The CRO's pharmacy procedures and also the data management process could have been improved. The Pharmacy seemed not in tune with the randomization procedure, needed additional management from the Sponsor and from the clinical department/project management department, and made a dosing mistake that could have been avoided. Data management was also an issue. The data management group did not seem trained on the protocol nor aware of the study timelines.

Lessons Learned from the Experience

We learned that it is imperative to provide our own protocol training to all functional groups within the CRO. In addition, we think that having an overseas data management group is not preferable when doing a US based study. There was not an opportunity for out of the box thinking on this study, just additional management of the pharmacy and data management groups.