News Releases

News Releases

Synteract Presents Webinar on Integrated Summaries: Planning for the Unexpected & Reacting to the Unforeseen

RESEARCH TRIANGLE PARK, NC– October 15, 2019Synteract, an innovative CRO partnering with biotech and pharma companies to bring new medicines to market, will host a complimentary webinar on “Integrated Summaries: Planning for the Unexpected & Reacting to the Unforeseen” on Wednesday, October 30, 2019 at 8a.m. PST/11a.m. EDT/4p.m. GMT/4p.m. CET.

A decade of clinical development may go into creating the Integrated Summaries of Safety & Efficacy (ISS and ISE respectively), critical in FDA submissions to help determine the safety and effectiveness of drugs in development. But even with proper planning, timely delivery is not guaranteed. Nancy Fitzgerald, MS, MBA, Director, Biostatistics at Synteract will discuss common pitfalls drug developers may fall in to in developing these integrated summaries, and how to avoid them, to increase likelihood of drug approval.

Nancy Fitzgerald brings more than 20 years of experience in pharmaceutical, biologics, and medical device research across all phases of development (Phase I-IV). She has extensive experience in regulatory affairs including interactions with regulatory authorities. Her experience also encompasses study development, clinical operations, data management, statistical analysis, quality, and auditing across a broad range of therapeutic areas. While in executive management roles she has managed more than 35 programs resulting in U.S. FDA approval.

Biotech and pharma professionals can register for this webinar here or contact Synteract for additional information.

About Synteract
“Bringing Clinical Trials to Life” represents Synteract’s commitment to engage with drug developers, patients, investigators, and regulatory experts, to bring insights to action and make better therapies a reality. Synteract supports biotech and pharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted nearly 4,000 studies on six continents and in more than 60 countries. It has contributed to more than 260 product approvals. Synteract offers a notable depth of expertise in oncology, general medicine, dermatology, neuroscience, pediatrics, and rare and orphan diseases. Connect on LinkedIn and Twitter.

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CONTACT:
Beth Walsh
beth@clearpointagency.com
760-230-2424

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