Expect Nothing Less: Expectations of a Contract Research Organization

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

The pharmaceutical, agrichemical, chemical, and biotechnology industries depend heavily on Contract Research Organizations (CRO’s) to provide high quality, scientifically sound laboratory and field-based services.  And to do so with minimal input from the Sponsoring organization on the routine aspects of study design, conduct, and reporting.  After all, many CRO’s have decades of cumulative experience relative to experimental design and execution as well as what regulators are likely to accept.  In addition CRO’s have deep knowledge of standard practices and individual registrant nuances that can be leveraged to ensure high quality and regulatory acceptability. The overriding goal is to ensure quality science while meeting challenging development timelines.

The basic expectations of a Contract Research Organization have not changed:

• The CRO will conduct studies that satisfy scientific regulatory requirements and customer reporting standards

• The CRO will ensure communication is proactive and timely

• The CRO will offer proactive technical advice and feedback based on practical experience

• The CRO will ensure consistency of approach across all projects within the organization

Likewise the basic expectations of a Registrant have not changed:

• The registrant will provide all study specific information relative to desired project design and will provide deadlines for deliverables

• The registrant will supply specific information about the test material (if available) including analytes and analytical methods, expected behavior of test material, expected toxicity, and any specific requirements required to ensure consistency of testing strategy

• The registrant will provide technical advice and feedback based on practical experience with the test material and experience of approaches received from regulators

• The registrant will ensure timely communication to the CRO relative to study plan and report reviews, responses to study updates and suggestions/questions, and timeline changes

A lot of what makes a successful partnership isn’t strictly science – communication and transparency are everything.