Frenova recently welcomed another clinical research site into its managed site business. The new group — led by Michael Roppolo, M.D., of Renal Associates of Baton Rouge — adds 7,500 patients, three principal investigators (PIs), and 10 sub-investigators to Frenova’s managed site business. But why would an established site decide it’s better to let someone else manage it?
As physician practice management and participation in clinical research becomes increasingly challenging, principal investigators (PIs) are looking for ways to cope. The Tufts Center for the Study of Drug Development (CSDD) reports that research sites’ work burden increased as much as 73% between 2002 and 2012. Applied Clinical Trials indicates that 40% of researchers quit participating in trials each year, citing increasing protocol complexity, associated data collection, and regulatory requirements as factors.
Outsourcing the management of a clinical research site, while still acting in the capacity of a PI, offers key efficiencies that lessen the burden of running a research site business, potentially making research activities more rewarding and allowing PIs to focus more on their duties as physicians.
Here are five research business activities that can be outsourced, saving PIs time, headache, and expense.
- HR for research staff
Hiring, training, and retaining qualified research personnel is critical for the success of any investigative site. These can also be very time-consuming activities. A site management business can assume responsibility for HR related activities, including hiring, benefits administration, training, and day-to-day practical people management and leadership.
- Contract and budget negotiations
Negotiating clinical research contracts and budgets is a specialized skill. By leveraging experts in the field, PIs may be able to achieve more advantageous terms. Site management specialists can take on such research-related legal and contracting activities. In addition to ensuring fair terms for research work, fast, skillful negotiations can speed study startup and compress timelines.
- Financial accounting
Research generates its own set of accounting demands and requirements; work that can also be outsourced to a site management business. This includes proper invoicing and receivables, accounts payable, collections, and management of patient stipends.
- Business development
With a busy medical practice, it can be challenging for some PIs to spend time marketing their site and searching for new study leads. A site management business can find new study opportunities for PIs, while nurturing ongoing relationships with sponsors.
- Overhead cost reduction
Site management businesses can create further efficiencies by distributing operating expenses across multiple sites. Economies of scale can be achieved related to technology, training, staffing, back office functions, etc.
The benefits of outsourcing site management, according to Frenova’s newest site:
At the Baton Rouge site, Frenova oversees all operational trial activities, including training and management of Frenova’s clinical research staff working at the site. Frenova also manages protocol adherence, data quality, site payments, financial accounting, regulatory obligations, drug accountability, and overall study performance.
Dr. Roppolo explains the benefits this way:
“Frenova is improving health outcomes and patients’ quality of life. By inviting Frenova to direct the clinical research staff and trial operations, we are accelerating patient enrollment, growing our research business, and ultimately helping people by introducing new treatments to the market.”