Service Description

The study was intended to provide preliminary information on local and systemic effects as well as toxicokinetics for an injectable depot product.

What Went Well

The CRO did a good job of preparing for the study. The formulation was difficult to work with so I attended a practice session to familiarize them with the formulation and the proper technique for filling the syringes for dosing. Their staff was very attentive and the quickly learned how to work with the formulation. The practice session helped a lot in preparing the staff for the day of dosing.

What Could Be Improved

The staff did a good job. I cannot think of anything they could have improved upon. They showed good attention to detail and willingness to do something different like the practice session.

Lessons Learned from the Experience

I have always expected and received good work from this CRO. This study was no exception. The CRO did not provide an innovative solution but they were very open to working with an unusual formulation that required different procedures than they normally use when they prepare suspensions for dosing. My experience with this study confirmed my belief that this CRO does its best to please the client even if it means doing something different from their routine procedures.