Abstract

Guide on Selecting CRO and How to Avoid Financial Losses in BE Study

Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd

There are clear guidelines to assess bioequivalence and each regulatory authority has its own thought process and expectations from these bioavailability and bioequivalence studies. Overall, sponsor has a general view of the criteria used to select Clinical Research Organizations (CRO’s). The pharmaceutical industry makes widespread use of CRO’s and most likely, this trend will increase in the coming years. But little empirical research exists on why and how pharmaceutical companies select CROs.

There are significant issues reported by regulatory agencies with CROs which leads to repetition of study. This impacted them financially along with loss of time for marketing processes. For a sponsor, selecting the right CRO is crucial and vital to the success of any bioequivalence study. It is important to choose partners that are not only capable of doing the work but can work well as a team. There are several factors to keep in mind while choosing a CRO.

So how does one go about selecting the best CRO for the job to Avoid Financial Losses? This is our topic for discussion