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
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