PHILADELPHIA, November 20, 2015 — Proposed updates to the International Conference for Harmonization Good Clinical Practice guidelines would be the most significant changes to international clinical research guidance in 20 years. What’s changing, and how will it affect you?
Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will discuss proposed revisions to GCP-related regulations and guidelines at the Ethics & GCP Forum in London, Monday, Nov. 20. Dodsworth will co-present Key GCP Updates at 3:50pm, providing a summary of changes since the last Ethics/GCP Forum meeting.
Drawing on more than 25 years of experience in quality assurance, Dodsworth will examine revisions intended to modernize the guidelines in response to the increased scale, complexity, and cost of clinical studies — and to foster innovative approaches to trial design, management, oversight, reporting, and documentation.
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 84 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.