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Handout for CRO presentation at Biocom 2 19 14

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Information about Handout for CRO presentation at Biocom 2 19 14
Health & Medicine

Published on February 20, 2014

Author: mwright1

Source: slideshare.net

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Paul G. Nardulli, Esq. Optima Law Group, APC 9990 Mesa Rim Road, Suite 250 San Diego, CA 92121 (858) 526.6564 paul@optimalawgroup.com 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?  1

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