Medical and Regulatory Affairs

Chief Medical Officer Discussing Early Regulatory Engagement at OCT Southern California

DURHAM, N.C., November 2, 2018 — Premier Research’s Chief Medical Officer will discuss bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England, November 6, in Boston.

Dr. Colin Hayward will address strategic and practical considerations for engaging with regulatory bodies on the opening day of the annual gathering of pharma, biotech, and medical device leaders. Topics will include:

  • Early regulatory engagement and creating a sound development strategy
  • Assessment and hiring of key staff members: which positions to fill immediately and which can wait
  • Ingredients for a cost-effective infrastructure and strategic trial oversight
  • Making the best use of a biotech startup’s limited resources

Premier Research is also a featured sponsor of OCT New England. Learn more here.

About Premier Research

Premier Research is a leading clinical development service provider that helps biotech and specialty pharma innovators — small companies with big ambitions — transform life-changing ideas into new medicines. The company applies a relentless focus on quality in the execution of global, regional, and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical devices, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,300 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that transform breakthrough biotech thinking into reality.