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Clinical Trials Contracting Issues: Managing the Outsourced Relationship

Learn how to successfully manage outsourced relationships in clinical trials. Understand key contracting issues, drafting term sheets, and legal considerations. Establish clear expectations, address potential problems, and protect data integrity.

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Clinical Trials Contracting Issues: Managing the Outsourced Relationship

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  1. Clinical Trials Contracting Issues: Managing the Outsourced Relationship Linda D. Bentley, Esq. May 18, 2007

  2. First Steps • Consider reason for outsourcing • Research potential contractors • Consider relationship with contractor • Draft term sheet

  3. Parties • Clinical Site • Contract Research Organization (CRO) • Contract Manufacturer • Clinical or Imaging Laboratory • Data handler

  4. Agreements • Identity of parties • Definitions • Applicable laws • Ownership and use of data • Confidentiality • Indemnification • Insurance • Representations and warranties • Post-termination requirements

  5. Clinical Sites • Parties • Institution and/or Investigator • Ownership and use of data • Clinical results • Intellectual property • Informed consent and HIPAA authorization • Indemnification and allocation of risk • Mutual or one-way • Limit to third-party claims • Treatment of injury to research subjects • Applicable law and standards of practice

  6. CRO • Scope of services • Delegated authority • Staffing changes • Location of services • Indemnification

  7. Contract Manufacturing • Applicable standards • Ownership and use of manufacturing procedure and IP • Transfer of and continued access to technology • Changes to procedures or specifications • Indemnification and insurance • Limitation of liability • Warranties

  8. Data Handling and Analysis • License agreement • Term

  9. The Message • Give careful thought to the purpose and nature of the relationship • Be clear about what you expect • Identify potential problem areas and address them before the work begins

  10. Linda D. Bentley, Esq. One Financial Center Boston, MA 02111 (617) 348-1784 LDBentley@Mintz.com

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