Drafting Clinical Trial Agreements

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This one-day practical course provides a detailed review of the legal, regulatory, design, and practice issues that arise when designing and negotiating clinical trial agreements (CSAs) and other contractual documents that arise when conducting clinical trials, for example.B agreements between a sponsor and a clinical research organization (CRO). Topics covered include: raw sources or documentation developed by the university during the conduct of a clinical trial may not be considered or treated as the property of the sponsor, nor may it be considered or treated as confidential information. Since the organizing party pays the CMA to conduct a study, the counterpart is an indispensable part of the CTA. The involvement of the UCI faculty in the development of the protocol and/or the design of the studies creates additional problems that both parties must fully address. Therefore, different or additional contractual conditions must be negotiated. Mark has nearly 30 years of experience in developing, negotiating and advising contracts for life sciences companies and universities, including CTAs. He is editor-in-chief of Drafting Agreements in the Biotechnology and Pharmaceutical Industries (OUP lose leaf since 2008). He has a long experience in the assignment of courses in CTAs. For several years, he has been recommended by Chambers Directory as a national expert in life science transactions and for patent licensing by IAM Patent 1000.

His 5-day course on IP transactions, organized by UCL with about thirty volunteer speakers, won both a Highly Commended Award of Excellence and a Provost`s Teaching Award. When negotiating a CTA, the parties should reject responsibility for a breach by a study participant as a result of their participation in the clinical trial. . . .