CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Mitchell Katz, head of clinical research and drug safety operations for Purdue Pharma.

Q: What are lean models for outsourcing in clinical research, and how are they intersecting with recent trends in the industry?

A: It’s about outsourcing to the companies that can do the most for you and making the commitment to become more productive at what you’re doing in-house. Overall, the defining factor is a very strategic, thoughtful approach to deciding on key competencies that any organization must hold internally, as well as others they will oversee at a high level in order to stay lean. The thought is that this leads to greater efficiency and a focus on what really matters. You select partners that are truly an extension of your organization. It is a trend that started 10 plus years ago, but it’s getting bigger.

Companies that are too small to develop deep operations in-house and big companies that have downsized have experienced the pressure for greater efficiency and decided that lean models are the most rational approach. Organizations will make the decision on what they determine to be the key competencies they must retain in-house, measured alongside those they feel comfortable letting go of and moving to the outside. In doing so, you then don’t need a full development organization to operate.

Q: What are the downsides of lean models that may be holding companies back from using them?

A: One downside is that the operational elements of the drug development process are not fully in your control, so it’s more of a risk-based approach. You must rely on the expertise of a provider to perform, and their motivations may not always be aligned with yours. Lean models also rely on procedures that may not be the same as what your company is used to doing. Those you outsource to may also be outsourcing to others. It’s hard to let go and allow the vendors to do the work.

Also, many companies struggle with deciding what they should outsource and what they should keep in-house. Many want to hold on to data management and statistics, and they also believe that owning the clinical regulatory strategy is paramount to the success of their approval. All of this is about change and increasing change management. If they get too focused on what could fall through the cracks, they may not be willing to go into a lean approach that forces them to focus more heavily on the outside.

Q: What do you expect this space to look like in five to 10 years?

A: Here’s what I see: Lean organizations will move toward more high-level, metrics-based management, more process optimization and better refinement of key competencies on what to keep in-house and what to outsource. Companies will get better and better at working in this kind of environment and retaining important staff, which will be key.

There will be a focus on data-driven oversight—the use of technologies and analytics. What I foresee is more risk-based and customized models, and less fear of the downsides, as well as much more comfort about regulatory support. I think the industry will get much better at data-driven approaches for managing their critical operations.

The FDA is now very supportive of, and focused on, working within a risk-based approach. The industry now needs to learn what that means and get comfortable with it—as long as we continue to provide oversight to our vendors, which is our regulatory responsibility. Senior management sees this as a lot of risk, and tends to be afraid of it. But there’s nothing to fear; you are still taking ownership of processes that are critical to the overall goals of the trial.

This article was reprinted from Volume 21, Issue 37, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »