It's always been understood that a carefully negotiated clinical trial agreement will protect a bio-pharma and medical device company. But as clinical research is increasingly being conducted overseas, sponsors need to be much more aware of local laws and regulations.
The Negotiation and Development of a Clinical Trial Agreement was pPublished in The Journal of BioLaw & Business and pays heed to the growing importance of well executed clinical trials:
"With clinical trials playing an ever increasing importance in the life and valuation of a biotechnology company, the Company must insure that, through the clinical trial agreement, it maintains the appropriate management and ownership of the data and publication, control of confidential information and ownership of the intellectual property, while securing the needed relationship with the Institution and Principal Investigator."The article goes on to highlight global clinical trial challenges in the areas of:
- Publication and confidentiality
- Intellectual property
- Indemnification and insurance
- Termination, and
Reprints or online versions of the article may be hard to find. If you are interested in reviewing it, contact the author, Peter Finn, directly.
For more information on global clinical research, visit the following links:
- Global clinical research - unethical or business necessity?
- Increased focus on clinical trial insurance
- Site saturation (or lack thereof) is a big driver for global clinical research
Find out more about ForeignExchange's specialized medical translation services for international clinical trials.
Categories: clinical research