What Makes a Good Protocol Template? Premier Research Addresses Meeting in Prague

PHILADELPHIA, October 13, 2015 — What makes a good protocol template for a clinical trial? How can the principles of quality by design be applied to creating a better protocol?

Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will address those and other questions Oct. 13 when she presents The Protocol and QbD at the European Forum for Good Clinical Practice’s Risk-Based Management of Clinical Trials workshop in Prague. Dodsworth’s presentation at 11:30 will set the scene for the event’s afternoon session on understanding and assessing risks in a sample protocol.

Patient safety and data integrity depend on effective risk management, a fact European Union regulators have underscored with new clinical trial regulations that take effect next May. The new rules impose major changes in trial application, operations, documentation, and assessment.

Dodsworth also will speak at the forthcoming conferences:

  • Research Quality Association (RQA), Nov. 11, Leeds, U.K., presenting: Working Towards a Smarter Tomorrow
  • Institute of Clinical Research, UCL, Nov. 20, London, co-presenting: Key GCP Updates

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.