Organizational Structure Proves Crucial when Determining Pharmaceutical Compliance Leadership
Only 25% of surveyed Top 20 pharmaceutical companies have centralized compliance teams, according to a recent study by Cutting Edge Information.
The study, “Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing,” found that the pharmaceutical industry views compliance as sufficiently critical to the brand and corporate success that they routinely place high-level leadership at the helm. As a result of recent, well-publicized audits by government regulatory bodies – such as the Office of Inspector General (OIG) – pharmaceutical compliance teams have shifted their focus to building stronger compliance structures. These compliance teams have become increasingly powerful entities across the drug manufacturing industry.
“Compliance is something of a buzzword used by many functions within drug companies,” said Ryan McGuire, research team leader at Cutting Edge Information. “From marketing to clinical operations to medical affairs groups, they all understand the potential consequences of failing compliance standards.” The buzz around compliance is mostly attributable to recent actions by regulatory authorities combined with what many view as a changing public perception of pharmaceutical companies. These events have forced pharmaceutical industry leaders to reexamine the way in which their companies manage compliance.
Organizational structure plays a significant role in compliance team leadership among surveyed companies. Directors or managers typically lead decentralized compliance teams. Centralization provides an opportunity to situate compliance team heads closer to the company's strategic center. Therefore, according to Cutting Edge Information's study, centralized companies tend to have a high-level vice president or chief compliance officer in charge.
“Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing” (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 goals identified by benchmark partners, including:
- Building a well-structured compliance team based on company needs.
- Understanding benefits of different compliance team structures, staffing, and budgets.
- Winning critical resources by increasing and communicating team performance and efficiency.
For more information about pharmaceutical compliance benchmarking, contact Elio Evangelista at 919-403-6583.
Cutting Edge Information
Elio Evangelista, 919-403-6583