I will be giving a web presentation on July 30, 2009 at 1 pm CST to discuss my experiences and recommendations for the utilization of Contract Research Organizations (CROs) by pharmacuetical, biologics and medical device companys who engage in clinical research. Please join us by registering at http://www.q1productions.com/store/product_info.php/cPath/30_42/products_id/80
Thanks. Hope to "see" you there. If you have any specific issues of concern that you would like me to cover, please contact me.
Steve Schurr
This blog is written by Mr. Steven C. Schurr, Esq. and focuses on health care law matters that pertain to food and drug law, regulatory compliance, privacy rights, insurance coverage, state and federal disability coverage, patient advocacy issues, and mental health coverage and treatment.
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4 comments:
How can you ben certain that a CR) provides you with experienced individuals to work on your project? The individuals that meet with you during the marketing phase may have impressive credentials and may give you a hard sell, but then once you hire the CRO, your firm may be working with far lesser-experienced individuals. CROs often operate in this fashion to increase their leverage and their profits. What steps can you take to ensure that the CRO provides you with the experienced people that you require?
If you decide to hire a CRO, how should you structure the contract with the CRO in regards to payment? Is it better to offer the CRO a flat rate, or per diem rate, for particular services, or is it preferable to agree to an hourly rate for the services to be provided? What are the advantages and disadvantages of both payment methods and what types of particular tasks lend themselves to a particular payment method? Find out by attending the webinar on July 30!
What is the biggest mistake made by sponsors in their utilization of a CRO? It is overdelegation and failure to properly supervise the conduct of a CRO. Yes, one might think that a sponsor would hire a CRO so that they, the sponsor, would be alleviated from the day to day operations of the project for which the CRO was hired. While this may be an objective of the utilization of a CRO, the sponsor must remain actively involved in the execution of the project to ensure that requirements are being met and that communication is flowing freely to the utmost decision-makes at the sponsor.
I am interested in the process for due diligence in choosing a CRO.
Thanks.
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