Pharma Audible

Fierce Biotech and the Wall Street Journal reported today on the evolution of Research & Development at Eli Lilly.  In a nutshell the pharma giant is changing the way it gets from novel molecule to blockbuster drug by outsourcing more and more of its R&D operations to CROs instead of running them in house.  On the surface, it makes sense that most huge pharma/biotech companies cannot reasonably do everything at once without tearing themselves apart, but this trend (which is mirrored by companies like Sanofi, GSK, and Pfizer) also has implications for clinical research sites.

For example with Lilly's growing investment in CROs for R&D, it is exceeding important to maintain strong relationships with CROs as they will provide valuable feedback to the study sponsor about the quality of work coming out of research sites.  If a site is a high enroller, collects clean data, has few deviations, and is generally pleasurable with which to work, then that site would likely receive a favorable recommendation from the CRO to the sponsor.  Present studies beget future studies, and the best way to ensure this continues (and that we all stay in business) is to provide high quality work with high quality customer service.  I believe that Lilly's movement towards more collaboration with CROs is a sign of the changing times, and sites must work harder than ever to ensure that a good reputation precedes them when being considered for new studies.  A good reminder of this fact comes straight from the Code of Federal Regulations that basically says if a sponsor elects to delegate certain clinical trial responsibilities to a contract research organization, then that organization assumes the role of the sponsor....keep that in mind when working with CROs...they have essentially the same authority as the sponsor itself!

Oh, and here's a few reminders about good customer service:

-Be prompt in returning voicemails and emails (every "customer" is important!)
-Act/Dress appropriately when working directly with sponsor/CRO representatives
-Respond to requests in a timely manner...this includes queries/data entry (few things please a sponsor more than fast/accurate CRF transcription)
-Be organized! (this took me a long time to figure out, but I'm glad I did!)
-Be confident, but not cocky...know your stuff, but don't flaunt it.