Negotiating Clinical Trials with For-Profit Companies

Wednesday, May 30, 2018 - 2:00pm to 3:00pm

The complexity and competitiveness of conducting clinical trials continues to grow as more institutions and sites look to increase their trial volume. Additionally, there is an increased interest in developing technologies and innovations to deliver improved patient care by healthcare providers and pharmaceutical, device and biomedical companies. This comes at a time where federal regulatory bodies are trying to harmonize the regulation to keep pace with research development. For contract specialists and clinical research administrators, the challenge of quickly negotiating a clinical trial agreement can seem daunting. This webinar will cover how to address the legal, regulatory and ethical standards which apply to clinical research and development within the context of clinical trial agreements. In addition to these standards, we will address administrative, operational and financial requirements that are critical to successfully conducting clinical research. Finally, we will address the different viewpoints and perspectives from the parties involved, including study teams, participants, study sponsor, product manufacturers, clinical research organizations and institutions/hospitals. In particular, we will address the key terms of the clinical trial agreement that are often the hardest terms to negotiate as they are the terms that illustrate the different expectations and values that research institutions and industry sponsors have and that often conflict.

Learning Objectives:

  • Understand regulatory, legal and ethical standards that need to be addressed in the clinical trial agreement
  • Understand operational and financial issues, including budgeting, coverage analysis and reporting requirements that need to be addressed in the clinical trial agreement to ensure study teams can comply with institutional and regulatory requirements while conducting the trial
  • Identify and address key issues and terms that are critical to a clinical trial agreement which are often the areas where study sites and sponsors differ on their position and where they spend most of their time negotiating the terms.
  • Learn how to use tools and best practices to improve your negotiation skills with industry sponsors on clinical trial agreements while leveraging tools and best practices

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Angela R. Charboneau Wishon, JD, Principal, Wishon Consulting, LLC
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