Safe Guards for Third Party Clinical Studies in the Animal Health Arena

September 15, 2016 11:15am

Ann R. Donoghue DVM, MS
VetDC, Inc. Authorized Representative
Regulatory Affairs (Fort Collins, CO)

Gary Yingling
Partner
Morgan, Lewis & Bockius LLP

  • Overview of clinical trial requirements for animal drugs and therapeutics
  • Examining the use of third parties such as CROs in conducting clinical trials for animal drugs
    • addressing legal and regulatory concerns relative to such contracting and outsourcing
  • Working with outside organizations such as CROs to design studies that show desired results and satisfy FDA protocols
  • Drafting contracts with third parties for clinical research that ensure IP protection of your product and subsequent findings and discoveries
  • Ensuring protection of study publication rights when working with a third party organization