Achieving Uncommon Success in Rare and Ultra-Rare Disease Studies Webinar

PHILADELPHIA, March 02, 2015 – Premier Research and Alexion Pharmaceuticals will co-present a webinar on achieving uncommon success in rare and ultra-rare disease studies on Wednesday, March 11, at 11am EDT (NA) / 3pm GMT (UK) / 4pm CET (EU-Central).

Don’t miss this opportunity to hear a study sponsor and a leading contract research organization examine practical considerations for every stage of the development process. Topics to be addressed include:

Program design — understanding natural history, reducing sources of bias, and validating endpoints.

Protocol design — reducing the need for protocol amendments.

Patient recruitment and retention — determining the number of study sites, managing patient travel, incorporating international patients, and knowing what questions to expect.

Preparing for site inspections by the FDA.

The webinar will be hosted by the below panel of experts:

Angi Robinson, Executive Director and Scientific Account Leader for Premier Research. Angi’s extensive experience includes oversight of global studies in pediatrics and rare diseases.

Patricia Nowowieski, Head of Global Clinical Operations for Alexion Pharmaceuticals. Patricia’s work in global clinical trials involves specialized populations and complex logistical and regulatory challenges.

Mallory Bissett, Associate Director of Global Clinical Operations for Alexion Pharmaceuticals. Mallory focuses solely on rare diseases, including late-stage, ultra-rare disease products.

Register Today

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

Author Details

Jodi Snare
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