News Releases

News Releases

Synteract Augments Biostats Team with Multi-disciplined Expert

RESEARCH TRIANGLE PARK, NC– Oct. 25, 2019Synteract, an innovative CRO partnering with biotech and pharma companies to bring new medicines to market, has added Nancy Fitzgerald, MS, MBA, CCRP, an experienced leader with cross-functional expertise, as biostatistics director. Fitzgerald has more than 21 years of experience as a lead biostatistician, project manager, program director, and medical writer for the analysis of Phase I – IV trials, working primarily in dermatology, pain, and diseases affecting the respiratory, cardiovascular, and digestive systems. Her hire continues Synteract’s mandate to add clinical strategists with multidisciplinary experience in developing and operationalizing global strategies.

Fitzgerald’s clinical trial experience has resulted in 41 NDA, ANDA, PMA and 510k approvals. At Synteract, she will lead complex studies and programs with responsibility for statistical methodology and output quality. She will develop or review relevant sections of clinical protocols, provide input on study design, define relevant statistical endpoints and tests, as well as review randomization methods and sample size calculations. In addition, Fitzgerald will provide biostatistical support at FDA meetings.

According to Helen Hall, vice president biometrics at Synteract, to whom Fitzgerald will report “Nancy is a great addition to our team. Her breadth of knowledge in complex statistical areas is enhanced by deep experience, and her background of working in several different therapeutic areas provides another great asset to our growing multidisciplinary leadership group and to our clients.”

Join Fitzgerald as she leads a Webinar on Wed., October 30 at 11 am EDT/3 pm GMT/4 pm CET/8 am PDT on “Integrated Summaries: Planning for the Unexpected & Reacting to the Unforeseen.” In this complimentary Webinar she will discuss what happens when an integration goes off the rails, and years of hard work and careful planning are at risk of falling apart. She will address types of issues drug sponsors may face affecting the integration process and ways to react to them, and even more important, how drug developers can proactively manage their impact.

Synteract offers biostatistics services in several ways: as part of a full-service clinical research project; as a consulting service to develop strategies to improve drug developers’ processes and oversight; and as a standalone project for those clients who are handling other aspects of trials in-house.

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 240 product approvals. Synteract offers notable depth of therapeutic expertise in oncology, dermatology, general medicine, neuroscience, pediatrics, and rare and orphan diseases. Connect on LinkedIn and Twitter.

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CONTACT:
Beth Walsh
beth@clearpointagency.com
508-829-2543

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