Where’s Your CRO Relationship Headed?

By Jon Rhodes, M.S.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com

For many in the pharmaceutical, agrichemical, chemical and consumer product, and biotechnology industries, outsourcing of laboratory, clinical and field-based product development and support activities is fast becoming an essential element of business success.  Many business organizations in these industries are shifting their internal focus to discovery and lead optimization along with management of regulatory and product support activities and timelines.  Laboratory, clinical and field-based research activities, along with the deep product knowledge that results from those activities is shifting to external Partners.

Outsourcing strategies are continually evolving and run the gamut from limited scope and intermittent use of a variety of individual CRO’s to extensive and continuous engagement of a limited set of CRO’s. Limited and intermittent relationships are typically based on fee for service or time and materials arrangements on a per-project basis.  The activities typically consist of single projects or a few small projects.  Companies that employ this strategy typically have a relatively narrow regulatory path to follow.  Continuous relationships are more often based on leveraging the scientific knowledge, skills, and experience of the CRO with the intellectual property, discovery activities, and regulatory drivers of the developing Company.  Outsourced activities typically revolve around the application of a broad range of scientific disciplines and cross multiple development programs.  Companies that are developing and supporting multiple products with global applicability and who are dealing with multiple regulatory authorities would benefit from this strategy.

Relationships with Contract Research Organizations (CRO’s) can be unpredictable and complicated affairs fraught with difficulty and uncertainty.  Regardless of the strategy currently being used any organization must continually evaluate the state of their relationships with CRO’s.  A successful relationship results in CRO Partners becoming a seamless extension of your product development team.  With quality science and meeting challenging timelines on the line, investing time in developing, nurturing, and growing relationships between your organization and a CRO Partner is essential to product development success.