RESEARCH TRIANGLE PARK, N.C.--()--One-quarter of surveyed pharmaceutical companies do not have dedicated compliance teams in place, according to a new benchmarking study by Cutting Edge Information. Instead, these companies task function-specific personnel with compliance responsibilities.
“Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing”
Conventional wisdom dictates that pharmaceutical compliance teams should be decentralized to remain closely tied to individual issues on the ground. That common practice translates into many companies fragmenting their compliance responsibilities to the point that different business units remain unaware of the other’s processes and policies. There are smarter ways to do structure compliance teams, according to the study, through a centralized organization.
Cutting Edge Information’s study, “Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing,” found that leading companies typically hire a chief compliance officer (CCO) to oversee compliance activities and alert senior management of systemic noncompliance issues, major regulatory changes, and the impact that those factors have on both developing and marketed products.
“Compliance structures vary greatly within the industry,” said Ryan McGuire, research team leader at Cutting Edge Information. “Although not all companies opt to hire a CCO, all companies can benefit from having a dedicated employee who oversees companywide compliance efforts.”
The study also recommends that companies draw a boundary between development and commercial compliance responsibilities. Compliance executives often complain that they are hampered by organizational deference given to compliance issues affecting drug development over commercial issues. Companies can avoid this common challenge under a centralized structure with a CCO who prioritizes both development and commercial issues and allocates responsibility to separate compliance teams.
“Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing,” available at http://www.cuttingedgeinfo.com/research/regulatory/compliance/, includes benchmarks and case studies for compliance team structures at large and small pharmaceutical, biotechnology and medical device companies. The report supports compliance goals identified by benchmark partners, including:
- Build a well-structured regulatory compliance team based on company needs.
- Understand benefits of different compliance team structures, staffing, and budgets.
- Win critical resources by increasing and communicating team performance and efficiency.
For more information about regulatory compliance teams, contact Elio Evangelista at 919-403-6583.