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Medical Writing Outsourcing Models

Track:
Medical Writing Regulatory Topics

Day & Time:
March 11, 1:30PM - 3:00PM

Room Number:
Ballroom Salon I

Type:
Session

Title:
Medical Writing Outsourcing Models

Chair(s):
Christine T. Ong, PharmD
Director, Medical Writing and Scientific Communications
AccelaRx LLC, United States

Description:
Regulatory medical writing continues to be an intrinsic function within the framework of the drug development matrix environment. As the industry vacillates between maintaining in-house staff and outsourcing medical writing to CROs, pharmaceutical and biotechnology companies need to develop appropriate business models to ensure success in the authoring and review of regulatory documents. Often, “mixed’ models incorporate both in-house and outsourced writers and appropriate metrics must be created.

Methodology in vendor selection and vendor oversight must be established and consistent practices in vendor management must be integrated across the therapeutic teams. This session will identify key elements that need to be identified in the sponsor-CRO relationship and discuss best practices in vendor management.

Learning Objective(s):
At the conclusion of this session, participants should be able to:
Identify and recognize the risks and benefits of different medical writing outsourcing models
Discuss criteria and metrics in selection and evaluation of outsourced medical writers
Discuss best practices and elements necessary for successful partnership from both a sponsor and a CRO perspective

Presentation(s) & Speaker(s):
MW Outsourcing: Finding the Best Fit
Christine T. Ong, PharmD
Director, Medical Writing and Scientific Communications
AccelaRx LLC, United States

Faculty
Darryl Zachary L'Heureux, PhD
Medical Writer
CSL Behring, United States

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