Managing Risk by Contract – Sponsor Perspectives on Clinical Trial Agreements

Provides effective approaches to negotiating clinical trial agreements.

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About this Webinar

Protracted clinical trial agreement (CTA) negotiations often delay the start of a study. Understanding each party’s motivation and expectations facilitates quicker issue resolution, thereby expediting the CTA to signature. This webinar discusses CTAs from the perspective of the study sponsor, providing tips along the way for streamlined negotiations. It addresses access and ownership of study data and specimens, the impact of digital health technologies and decentralized clinical trials, cybersecurity concerns, subject injury and indemnification provisions, and insurance obligations. The webinar also provides sites and investigators with an understanding of sponsor concerns with CTAs. It concludes by offering a set of effective strategies for the sponsor and research site to follow.

Webinar Demo:

Release Date: November 9, 2023

Language Availability: English

Suggested Audiences: Clinical Budget Specialists, Contract Research Organizations (CROs), General Counsel, Investigators, Research Administrators, Sponsors

Organizational Subscription Price: $300 per year/per site or included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person

Webinar Content

Managing Risk by Contract – Sponsor Perspectives on Clinical Trial Agreements

Presented by: Katherine Leibowitz, JD - Leibowitz Law

Learning Objectives:

  • Describe sponsor goals and concerns regarding study data, source records, and specimens in the clinical trial agreement (CTA).
  • Explain how digital health technologies (DHTs), decentralized clinical trials (DCTs), and cybersecurity concerns impact CTA negotiations.
  • Describe sponsor goals and concerns regarding risk allocation, including subject injury, indemnification, and insurance in the CTA.
  • Identify ways to expedite CTA negotiations.

Recommended Use: Required
ID (Language): 21143 (English)

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