FDA Guidance on Clinical Investigator Roles and Responsibilities

is being presented by Dr. Anita S. Kablinger, Virginia Tech Carilion School of Medicine and airs on February 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Clinical researchers face a steep learning curve. The importance of research, as well as the practice of participation in research, remains a relatively minor component of medical school and graduate medical education. Clinical investigators often have limited knowledge of the FDA rules and regulations in drug development other aspects of clinical research.

This presentation reviews the FDA guidance concerning what the clinical investigator – as well as those seeking qualified investigators – needs to know and demonstrate to provide academic rigor, maintain the highest safety standards of participants and promote the development of novel compounds and devices.

Academic Medical Centers and Clinical Research Productivity: How to Choose The Best Sites

is being presented by Anita S. Kablinger, Physician, Carilion Clinic
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com

Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?

This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.