Expertise
Life Sciences
Clinical Trials
Clinical trials are key to product research and development. It is critical that rights are protected and obligations are clearly defined in the clinical trial agreement, protocols, and related documents. We work with pharmaceutical industry sponsors, contract research organizations and institutions. Our expertise includes:
- Review of clinical trial protocols and ancillary documents, such as investigator's brochures, informed consent forms, and investigational new drug submission documentation for compliance with regulations, Health Canada guidelines and protocols
- Application of clinical trial provisions of the Food and Drug Regulations and other Health Canada and ICH guidelines relating to good clinical practices
- Advice on the application of federal/provincial privacy and protection of personal information legislation to the conduct of clinical trials and on specific provisions in clinical trial agreements allocating responsibility for the protection of patient information
- Drafting and negotiation of clinical trial agreements, including:
- Subcontractor agreements
- Service provider agreements
- Principal investigator agreements, including multi-centre studies
- Warranties and indemnities
- Allocation of liability
- Confidentiality clauses
- Intellectual property rights protection
- Publication rights
