Sites, ‘Smart Money’, and Standard Operating Procedures
Kurt Mussina at Paradigm Clinical Research outlines the best practices involved when running multiple research sites, and how to ensure site expansions occur smoothly.
ICT: When expanding the number of locations in a clinical research site business, what is needed to ensure efficacy in the supply chains and other logistics?
Kurt Mussina: Depending on the types of studies and therapeutic areas in which they are active, sites will require a certain set of common supplies and consumables. These are typically readily available from a variety of sources. For equipment and supplies that are less common or unique to a particular study, it is best practice to have the sponsor acquire and provide these to the sites.
Often, sponsors have greater purchasing power and influence than sites. White it is not common to use the term ‘supply chain’ to refer to the availability of volunteers who are eligible to participate in trials, this is a critically important consideration when expanding into new locations and new therapeutic areas. You cannot be successful managing a clinical research site if you can’t effectively access and recruit a sufficient population willing and eligible to join trials.
Finally, it is also critical to consider the importance of diversity and inclusion of underrepresented populations in clinical trial participation. This applies not only to volunteers but also to study investigators and site staff.
How important is collaboration with other businesses, such as private equity firms, when organizing site expansions?
Among many options, private equity is a common source of funding when expanding any business, whether through de novo or acquisition strategies. It is important to discern how familiar the private equity firm, or indeed any funding source, is with the marketplace in which you compete. Some funding sources are considered ‘not smart’ (i.e., unfamiliar with your particular market). Other sources are considered ‘smart money’ or referred to as ‘strategic’. These sources can often be collaborators, customers, or vendors with common interests and motivations.
Unless there are good strategic reasons to do otherwise, it is typically best for the business to self-fund an expansion – assuming, of course, it is in good financial condition to do so. Otherwise, strategic money can bring with it good value and certain advantages.
What are some common pitfalls of managing a clinical research site business across multiple locations, and how can they be avoided?
Sute businesses with multiple locations often manage the business in a way that appears from the outside as multiple businesses. This is especially true of site networks. This lack of integration fails to address many of the fundamental inefficiencies found in clinical research. For example, there are often separate clinical trial agreements and budgets that must be negotiated and executed for each individual site. Indeed, in these cases, separate and distinct standard operating procedures are often in play/
Integrating the site’s operations and centralising common services, such as accounting and business development, is one way to avoid this. Put another way, an operating model that regards the business as one large site with many locations delivers the strongest value to all stakeholders.
How might offering trials across multiple therapeutic areas impact the patient experience?
Study protocols often, if not always, exclude people already enrolled in another study. However, sites that participate in studies across multiple therapeutic areas can provide more options to people interested in participating. So, if someone turns out to be ineligible for a certain study, they could still meet the criteria for another study – having options can only be a good thing. In addition, deciding which therapeutic area to compete in is strategically important for the site.
Disease areas and indications that are adjoining can provide a competitive advantage. A good place to start is by considering the complications that often arise with a particular medical condition. For example, nephrology, endocrinology, and cardiology are specialties that can overlap for certain patients.
What are some good practices when coordinating research teams across sites, including internationally?
Full operation integration is key. So is strong site leadership and a properly-aligned organizational structure.
Site leadership with good people skills is necessary. Combine that with good business acumen, and now you have a great recipe for success at that sire.
Site leaders must appreciate that they are managing a business jsut as much as they might be managing studies. That requires an understanding of how the business operates, how value flows and how to measure financial performance.
Beyond this, good, clear, and frequent communication is critical. The sharing of best practices and troubleshooting across sites, especially regarding enrolment challenges, can mean the difference between delivering outstanding value and mediocrity.
Read the full conversation with Kurt Mussina, CEO of Paradigm Clinical Research and Clinical Trial Supply and Logistics