Project Management

Come Together: The Foundational Team for your Heart Valve Study

An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study.

You build that foundation with your study’s first team: your business management team. This core team consists of your own outsourcing representative and your vendor’s business development representative; later, additional team members will join to execute on the base this team establishes. Business management team members are responsible for planning, organization, budgeting and pricing. No matter what design your study takes, their value cannot be overstated.

Together, the business management team begins the planning stage by asking five key questions; the answers impact every aspect of your study design:

  • Where: Is this a global study? A U.S.-only study? An EU-only study? Regulatory considerations may impact your answer—but more prosaically, from an investigative point of view you may want to work backwards by first considering which hospitals will best suit your study.
  • When: Is there a burning reason to start immediately—such as competitive pressure? If you have to rush into recruitment that urgency will affect your choice of study venue, since you would need to ensure that regulatory approvals will be granted quickly. If there is no particular rush, site selection can be keyed to a locating a highly targeted patient population.
  • Who: Do you need specific Key Opinion Leaders to be involved with your study? Do you need a partner who can facilitate rapid recruitment? Do you have a history of working with a specific partner? These considerations can help identify the most appropriate partners to achieve your goals.
  • Why: What is the primary business goal for the study? What does your company hope to accomplish through the study’s success?
  • How: Which parts of the operation will be kept in house, which parts have to be outsourced—and how can you guarantee that your internal and external resources will ultimately collaborate and become a team?

Once these key questions have been considered and answered, then you can begin identifying your contributing partners—and your relevant counterparts, the team members from each partner group with whom you will be working most directly. You also trigger real operational activities that begin to get the study underway. These include things such as:

  • Requests for proposal (RFP). You will send RFPs out to prospective partners and vendors of all kinds. In order for the proposals you receive to be accurate, you need to be both comprehensive in the information you supply and explicit about the details you expect to see.
  • Budgeting. You—and your prospective vendors—need not only to plan for all the cost categories, but to budget relative to the geography (or geographies) where you have decided to conduct your study. There is a difference in hourly rates, and, more importantly, investigative fees, not only between Europe and Australia, but between Central Eastern Europe and Western Europe.
  • Resource planning. Within the region you have selected, can you source sufficient available staff with cardiovascular experience in general and preferably valve experience in particular? Is there staff available with a history of successful collaboration, whether with each other, with the site or with your company?
  • Investigative site selection. You have narrowed it by region. Now consider which sites have the patient population you seek? Which has expertise in heart valve replacement? How does their standard of care match your study terms?  Are they prepared to agree to your contract terms and confidentiality requirements?
  • Establishment of a communication flow. Since device studies often run for a long time with very little on-site participation, clear, frequent, defined communication among team members is essential. How often will you talk? What medium will you use? Who is responsible for organizing the communication and for following up?

From this point on, throughout the trial, your business management team will oversee these operational features. Your collaboration with these teammates—and their further collaboration with the rest of the study team—is essential to the smooth functioning of your trial. Never underestimate the power and importance of your business management team. By working together, building a strong relationship from the start, you build a strong—and essential—foundation for success.

Check out additional team tips in our blog post on the full-team approach.