1 / 10

Clinical Trials Contracting Issues: Managing the Outsourced Relationship

Clinical Trials Contracting Issues: Managing the Outsourced Relationship. Linda D. Bentley, Esq. May 18, 2007. First Steps. Consider reason for outsourcing Research potential contractors Consider relationship with contractor Draft term sheet. Parties. Clinical Site

winnien
Download Presentation

Clinical Trials Contracting Issues: Managing the Outsourced Relationship

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related