IRVINE, CA — 10/30/09 — The stakes in clinical research have never been higher. Now operating in an environment in which a one-day delay can result in millions of dollars in lost sales, drug development companies are strengthening their ties with partner organizations to increase efficiencies and reduce timeline disruptions.
As a full-service contract research organization (CRO), Paragon Biomedical understands the vigilance required to protect clinical research resources. To share insights and benefit from the perspectives of others in clinical research, Tenley Koepnick, Associate Director, Site Management Services at Paragon recently attended the Site Solutions Summit.
The annual meeting brings together the key players of clinical research. Attendees at the mid October conference included drug and device development companies (known in the industry as Sponsors), and the contract research organizations (CROs), physicians (Investigators), healthcare professionals and vendors who manage and support Phase I through IV clinical trials.
In addition to attending meeting sessions, Koepnick facilitated a roundtable discussion focused on the issues surrounding site feasibility, the process used by Sponsors and CROs to identify the most qualified facilities for conducting a study. Feasibility is important because a site performing below requirements can delay study start up.
“The majority of clinical research in North America takes place at Investigative Sites, which can be anything from a physician’s office to a stand-alone research facility,” said Koepnick. “Because there are so many variables, so many different types of sites, accurately assessing an individual site’s ability to conduct a study is vitally important.”
Koepnick said the conference helped her understand how expectations are shaped by the interests and perspectives of each group. For example, she realized there is no single definition of what constitutes “site feasibility.”
“It means one thing to a Sponsor, something else to a CRO, and has yet another definition to Investigators and their staff,” she said. “Although it appears pretty simple and straightforward, that insight alone helped us collaboratively develop specific approaches to improve the site feasibility process in ways that are meaningful to Sponsors, CROs, and Investigators.”
Paragon Biomedical is a global, full-service, woman-owned CRO providing Phase I through IV clinical research services and support to the world’s pharmaceutical, biotechnology, and medical device companies