Clinical Research Coordinators Create Niche Business Offering Clinical Research Expertise to Private Medical Practices in Florida

Miami, FL, April 17, 2010 --(PR.com)-- Clinical Research Coordinators Deborah Eyerdam and Diane Paquet, both of South Florida, have partnered to create Certified Clinical Research Coordinators of Florida, a private company that will provide training and temporary staffing for MDs looking to expand their businesses and add a new income stream by acting as Principal Investigators and conducting clinical trials for pharmaceutical companies. “Conducting clinical trials can be a lucrative business, but as one would expect, it is also a stringently regulated business that requires the guidance of a trained coordinator’s oversight to assure the study adheres to Good Clinical Practice (GCP), the International Conference on Harmonization (ICH) and the Food and Drug Administration (FDA) guidelines and regulations,” explains Deb Eyerdam CCRC, CCRP.

In their years of working for a small research organization, both Paquet and Eyerdam recognized a growing trend. “There have been many shifts in this industry in the past decade or so,” explains Diane Paquet CCRP. “Not too long ago clinical trials were conducted mostly by universities. But as they gained a reputation for being slow and costly, more small research and site management organizations cropped up. And the latest trend we are seeing is the individual practitioners and private medical offices looking to hire temporary or part-time coordinators to conduct clinical trials.” Paquet and Eyerdam believe this trend will continue and have created their new business to provide a one-stop source for Florida practitioners interested in expanding into research.

The business plan for Certified Clinical Research Coordinators of Florida (CCRCF) is to launch the business in South Florida where Eyerdam and Paquet would personally manage trials. Over time, the two would add certified coordinators from across the state to geographically expand the business throughout Florida.

The many responsibilities that CCRCF will bring to a Principal Investigator include but are not limited to:

· Write, design and place IRB approved radio and print advertising for successful recruitment of participants.
· Negotiate budgets with sponsoring pharmaceutical companies or CROs.
· Create internal budget.
· Collaborate with Contract Research Organizations and/or sponsors on protocol and Case Report Form (CRF) design as needed.
· Prepare Institutional Review Board submissions.
· Oversee and/or conduct all facets of clinical trial coordination and management.
· Train staff on protocol procedures and Good Clinical Practice guidelines with emphasis on the protection and rights of patients.
· Maintain regulatory binder.
· Create source documents as needed.
· Complete source documents, CRF or eCRF documentation.
· Account for Clinical Test Material.
· Submit study closure documentation to IRB.

For more information about Certified Clinical Research Coordinators of Florida, contact Deborah Eyerdam at deb@ccrcf.com or 305-812-9008.

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