Working Effectively with CROs

Common Mistakes with CROs
Over 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 Objective
You 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 Step
Steven 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 Studies
Mr. 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?

Results
After this e-conference you will have an increased ability to choose and manage a CRO.

CROs will have a better ability to select a responsible client.

You will receive
[x] PowerPoint Slides.
[x] A speaker expert in contract law.
[x] A speaker with experience in clinical research.
[x] A chance for Q&A.
[x] CEUs & Certificate.

Audience suitability
[x] Clinical research professionals who participate in the CRO selection process.
[x] Managers who sign-off on CRO selection.
[x] CROs who want to improve their presentation.
[x] Executives who are planning the future of their company.

Presenter
Steven C. Schurr, Esq. worked extensively as a regulatory affairs and clinical research professional and consultant for 12 years within both the medical device and pharmaceutical industries prior to becoming an attorney. In 1994, Mr. Schurr graduated from Loyola University of Chicago School of Law and became a member of the Illinois State bar.  In 1995, Mr. Schurr became a member of the Indiana State bar.  Mr. Schurr currently concentrates his legal practice, based out of Chicago, in health care law.  Mr. Schurr is an advocate for patient’s rights, the disabled, the elderly and various health care organizations.  He also is involved in federal disability law, food, drug and device law, medicare, medicaid, medical ethics and federal patient privacy issues.  He can be reached at scschurr@steveschurr.com.

The purchase is $424 for OnDemand access and $474 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.