Five Criteria To Use When Selecting A CRO For A Gene Therapy Study

Contract research organizations (CROs) have been an integral part of drug development since the 1920s, first as providers of preclinical testing services, then as organizations that could manage clinical trials on behalf of their sponsors. While this makes the majority of CROs knowledgeable experts in the management of clinical trials, especially for traditional small-molecule therapies, not all CROs are equally suited to oversee trials of next-generation medicines such as cell and gene therapies (CGT).

This reality comes at a time when such therapies are quickly making their way from theory to clinical practice. Just four years ago, the first CGT treatment was approved by the FDA. Today, nine therapies are approved, and, according to PhRMA, the number of treatments in clinical trials increased by 25% over the past year, going from 289 to 362. Even more treatments are in preclinical stages and are expected to enter the clinical trials pipeline.

Given this, many biopharmaceutical companies are looking for CRO partners with significant experience conducting CGT-focused clinical studies. Here are five criteria to consider when evaluating organizations.