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.

ABC Wins Industry Awards 3 Years in a Row

Columbia, Missouri - 05/07/15 ABC Laboratories, Inc. has been named a 2-category winner in the 2015 CRO Leadership Awards presented by Life Science Leader magazine. Based on an annual survey of over 2,300 industry executives, this year's awards recognize service providers who were rated by industry as being in the top 10% of CROs. ABC received awards in Innovation and Regulatory categories.

"ABC is honored to have been recognized by industry three years in a row. It is rewarding to see investments aimed at delivering "better insight" and "better outcomes" to our clients are earning our organization a reputation for excellence," said John Bucksath, ABC's President and CEO.

Life Science Leader developed the annual CRO Leadership Awards in 2012 to honor top performers based on leading industry research conducted by professional market research agency Nice Insight. For this year's program, Life Science Leader narrowed the field of award winners by selecting only those companies that placed in the top 10% of each category, rather than the top 20% as was used in previous years.

In the May 2015 issue of Life Science Leader, the magazine asserted importance of this program. "Unlike other industry awards which are given based on a voting or nomination process, the only votes that count towards the CRO Leadership Awards are those of the pharmaceutical and biopharmaceutical companies using CRO services."

About ABC Laboratories

ABC Laboratories provides IND-enabling, registration and post-commercialization analytical support for the development, quality control and lifecycle management of innovative therapies and generic medicines. The company's personalized, results-based approach to development strategy is backed by decades of experience delivering GLP and CGMP-compliant analytical testing services across all types of active pharmaceutical ingredients and formulations. Through development know-how, cross-disciplinary technical expertise, and applied experience with evolving global regulatory frameworks, ABC helps efficiently manage programs for large and small molecule drugs, medical devices and combination products.

For additional information, contact Kristein King at 573-777-6209.

Information about the CRO Leadership Awards can be found at www.croleadreshipawards.com