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Paul G. Nardulli, Esq.Optima Law Group, APC
9990 Mesa Rim Road, Suite 250San Diego, CA 92121
(858) [email protected]
Checklist for Contractual Negotiations Between Sponsors and Clinical Research Organizations
1. Have your expectations from the relationship been communicated to each other and have they made their way into the contract?
2. Does the contract provide mechanisms to ensure tasks inside and outside the CRO are delegated to qualified people?
3. Is it clear what rights the parties have to the development Process and future use?
4. Have you adequately addressed confidentiality between the parties and extending to involved third parties that will have access to confidential information?
5. Have you addressed who will own resulting data and who will maintain the data?
6. Have you put procedures/requirements in place to cover you if the other party does not live up to obligations?
7. Have you included an escalation process to assist in resolving Disputes early and out of court?
8. Have you included language to protect your other resources, such as your employees?
9. Is it crystal clear who owns all intellectual property created and what right, if any, the other party has to use it?
10. Have you addressed when termination is allowed, what notice is required, and what timely steps must then be taken?
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