Best in Bio: Clinical Trials- Why Bother?
Thursday, March 18 2010
5:30 pm – 8:00 pm
The New Hampshire Bio/Medical Council has announced a series of education events called Best In Bio.
The first event scheduled for March 18, 2010 is "CLINICAL TRIALS-WHY BOTHER?"
All biomedical companies know the power of clinical trials. Whether for initial approvals, for reimbursement or for showing outcomes of existing products clinical trials add value to each enterprise.
Each year more and more regulations and institutional requirements add to the complexity and difficulty of completing effective trials.
The New Hampshire Bio/Med Council has bought together industry experts to discuss this important aspect of our business and to answer your questions. This outstanding panel includes:
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Cynthia L. Owens M.A., C.C.R.C. Vice President and Co-Founder of Asentral, Inc., Salisbury, MA
Asentral is an independent, central IRB offering ethical review and clinical oversight of clinical research in the community hospital setting. Since 2001 they have reviewed and overseen hundreds of private sponsor and NIH studies. They work with company and CRO managed trials. They provide the rigorous oversight needed to allow physicians who choose to work at community hospitals that do not have an affiliation with a large teaching hospital the opportunity to participate in clinical trials.
Cynthia is also an expert on patient recruitment and has written and presented on good clinical practice at national symposiums.
- John Schwope, President and Founder, Simplified Clinical Data Systems, Milford, NH
Simplified Clinical is headquartered in Milford, NH, with data center operations at the Pease International Trade port in Portsmouth. CDS has been a provider of information systems supporting the clinical data management needs of medical device companies for more than a decade. Their purpose is to help research organizations reduce and control the costs associated with performing clinical trials, while increasing the speed with which clinical trial data is collected, processed and made available for meaningful analysis.

- Peter N. Madras, M.D., F.A.C.S., Chairman of the Asentral, Inc. IRB
Dr. Madras graduated as a university scholar from McGill University School of Medicine in 1965. Until 1969, he headed the Biomedical Program at the Avco-Everett Research Laboratory, leading in the development of the early heart assist devices, some of which are still widely used today. From 1969 to 1975, Dr. Madras trained in surgery on the Harvard Service of Boston City Hospital, and in Vascular Surgery at the University of Toronto. He practiced as a vascular surgeon from 1975 to 1980 at the University of Toronto, then from 1980 until 2001 as a transplant and vascular surgeon at the New England Deaconess Hospital and Harvard Medical School. He was Medical Director of Grace Biomedical participating in the development of hybrid artificial organs. Dr. Madras has served as an associate professor of surgery at Harvard Medical School, and as member and Chair of the Massachusetts Board of Registration in Medicine. Dr. Madras retired from the active practice of surgery in 2001, and is currently research staff at Lahey Clinic, and Director of New Technology at Pluromed, Inc.
Attend this outstanding program if you are planning to sponsor a clinical trial, are currently sponsoring clinical trials or are interested in this crucial step towards taking a product to market. This will be of interest to regulatory and clinical professionals along with R&D and general management staff. Tickets are $25.00 for members and $35.00 for non members. The event, held at the Sheraton Portsmouth Harborside in Portsmouth, NH begins with networking from 5:30 PM until 6:00 PM followed by the panel. Light refreshments will be served.
Register for this event online!


