Q1 2014: Julie Aker, President & CEO, has been invited by Consumer Health Products Canada to present a webinar on the similarities and differences of the Rx-to-OTC Switch Guidelines for Canada and the U.S.
| June 19, 2007, Indianapolis, IN. Concentrics Research Director of Operations, Kurt Radke, MBA was selected as a session chairperson for one of the Good Clinical Practices (GCP) sessions at this year’s Drug Information Association Annual Conference in Atlanta, Georgia. Melanie Sells, BS, CIP, IRB Administrator for the Concentrics Institutional Review Board, provided a lecture on the history and current status of GCPs.
Timeline and process improvement related to the drug development cycle seemed to be the theme at this year’s conference. The Concentrics team delivered a session aptly titled: Good Clinical Practices (GCPs) and ISO 9000: A Winning Combination. Radke’s presentation provided insight on the implementation of ISO 9000 within the framework of GCP guidelines. This strategy can help to develop an auditable system resulting in improved processes and productivity within the clinical research discipline. ISO 9000, a quality system and certification traditionally applied to manufacturing, is gaining application and importance in service industries. “GCPs have to be followed in our industry. Building a process using ISO 9000 around GCP guidelines adds discipline. It’s a good fit,” said Radke. “There seems to be a large interest in the (clinical research) industry as we all become more familiar with the terms,” observed Radke. “The goal is efficiency in the long-run.” Six-Sigma in the clinical environment, another “buzz word” in quality improvement, was also a topic of interest and conversation. When asked about the cost of implementing quality systems like ISO 9000 and Six Sigma, Radke stated, “The cost is nominal related to process savings. You have to climb the hill before you get to roll down the other side. It may seem like you are starting from scratch, but you see where your gaps are. ” Radke and Sells felt that their presentation format worked well for the audience. It was concise, clear and ordered for understanding. The Concentrics team strategically developed their material in this manner. “We avoided the ‘gather around the medicine wagon-sales pitch,” stated Radke, “we were there to teach.” Overall, participating in the DIA was “a great experience,” stated Sells, “I’d like to be involved again next year.” About Concentrics Research: Concentrics Research, headquartered in Indianapolis, Indiana, is a niche CRO providing custom research solutions to leading pharmaceutical, biotechnology, and device companies. The Company’s Mission is “to be a premier Phase II-IV service provider committed to innovative research design and excellence in service.” Concentrics is committed to making a positive difference in the lives of their staff, clients and consumers. For more information, contact Concentrics at (800) 800-5525 or visit www.concentricsresearch.com. |
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