Pfizer's Five Year Plan Moves From Integration To Optimization

By Ed Miseta, Chief Editor, Clinical Leader

In 2010 Pfizer decided to evaluate its clinical development and operations model. The goal was to change the process to make it more effective and efficient. At that time the company had 17 large-scale vendors, as well as numerous smaller ones performing various aspects of clinical trial execution. “We were essentially utilizing a staff augmentation/functional sourcing model,” says Coleen Glessner, VP, Head of Clinical Trial Process & Quality at Pfizer. “We had data service providers, monitoring providers, study management providers, programming providers, and medical writing providers performing services for us in 67 countries. We realized at that point we needed better line of sight into the performance of our nearly 550 clinical trials.”

Also providing impetus to this effort were the two warning letters received by Pfizer in 2010, one in GCP and one in pharmacovigilence. When the decision was made to change the way its trials were conducted, the company undertook an extensive due diligence review process. This exercise looked at major CRO’s with sufficient global presence to support Pfizer’s extensive portfolio. . Following this review the company selected ICON and PAREXEL International. Contracts were signed in May 2011, and by the end of 2012 over 200 trials were transitioned from Pfizer and their existing vendors to the two new partners.