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.
Saturday, April 18, 2009
I welcome any questions or issues in advance from the audience. Please feel free to contact me if you have a question or issue you would like to have discussed. Please see below for more information about the upcoming e-conference.
Common Mistakes with CROsOver and over again sponsors make the same mistake when choosing a Contract Research Organization. They base the choice on cost rather than reputation, capability, demonstrated knowledge, contribution to the industry, and a match in size, philosophy, and attitude. Then, after having chosen poorly, they fail to manage the CRO or stay in close contact.
Learning ObjectiveYou will learn the regulatory, legal and financial pitfalls in the use of a CRO for a research project and how to protect your organization from such pitfalls.
Step by StepSteven Schurr, Esq. will walk you through the process of hiring a CRO for medical device research. He will cover:[x] The risks involved in utilizing a CRO versus hiring in-house employees to perform the tasks. [x] The best ways for a sponsor to solicit and evaluate potential CRO vendors. [x] Once the sponsor chooses a CRO vendor, how to structure the budget and contract.[x] How to monitor and evaluate the performance of the CRO during the project.[x] What happens if the project needs to be expanded beyond its original scope after the original contract is finalized. [x] What the sponsor should do if they choose to terminate the contract with the CRO while the project is ongoing.
Case StudiesMr. Schurr will use case studies of precarious situations to demonstrate what can go wrong, explanations of what caused the situations, and recommendations on how to avoid them.
Are You A CRO?For the CROs in the audience, Mr. Schurr will have a few words about choosing a client. Vendors should go through a selection process too, as was vividly demonstrated in the recent GAO sting operation against independent IRBs. You should ask questions like:[x] Is the client honest?[x] Do they want an ethical research study with data that have proven integrity?[x] Can they pay you?
Please join us in the discussion. You may learn more about the conference at the following link:
Thanks and I hope to see you there.