Clinical operations teams face some eye-popping challenges. Conducting clinical trials is expensive and time-consuming: 40% of sites in multi-center studies face under-enrollment, and 11% fail to enroll a single patient. 18% of patients who do enroll in a trial end up dropping out. What’s more, only one in ten drugs that reach clinical stage development make it to FDA approval and commercialization—and up to half of those failures are due to bureaucratic and procedural errors.
Clinical Operations Consulting: The Independent Option
As organizations invest in overcoming these challenges, they often find themselves with knowledge and resourcing gaps: business process expertise to support new software installations, operating model design to support organizational overhauls, and even project management support to keep transformations on track.
Independent clinical operations consultants are an excellent resource for these leaders, offering more targeted expertise and more flexible engagement structures than other resourcing options can provide. With training from top consulting firms, experience at leading pharmaceutical and biotech companies, and advanced degrees in areas such as chemistry and medicine, they can support clinical leaders by:
- Offering strategic advice and best practices in areas like pharmacovigilance, supply chain management, and Artificial Intelligence
- Supporting major business transitions with change and project management expertise
- Translating between business needs and research groups in areas like data science and market access
- Adding extra capacity as teams work to comply with new requirements and regulations
- Helping structure and build out new permanent groups
What makes independents so well-suited to projects of this nature? As independent pharmacovigilance expert Kerry Coffee commented: “What I see from clients is that they appreciate having the ability to bring in one or two individuals as opposed to a large team. As an independent, I can also work a bit more closely with my clients, rather than going off into a room with other partners and deciding, ‘Okay, here’s what the solution is.’”
Aside from the flexibility and intimacy of the work, independents also frequently bring very targeted expertise, especially compared to what’s available through large consulting firms. Independent clinical operations and forecasting expert Jeffrey Boschwitz pointed out, “The big firms often use people who haven’t done it a lot of times and don’t understand how to gather claims, audit, or prescription data and what the risks and limitations are.”
Speed is of the essence in life science product development. Delays cost, and so do mistakes. With the support of experienced independent clinical operations consultants, neither has to be an issue.
About the AuthorMore Content by Leah Hoffmann