Developing a well-functioning, compliant operational structure for a large, multi-therapeutic research organization is no easy feat. As no two programs are the same, no single solution to how a research program should be structured is available. Some have a silo structure, with research support stationed within each specialty. Others have one central research administration to which all support personnel report. Others, still, work within a combination of both.
To help determine what model works best for your organization, we have detailed three different site structure models below: Decentralized, Centralized and Hybrid.
The Decentralized Model is one of the most common models within clinical research programs. Unfortunately, this model is also one of the least stable or efficient, especially for larger organizations.
Decentralized site structures are fragmented with each specialty area acting independently from the others, establishing its own hierarchy and processes with little to no alignment with the overall organization.
This level of autonomy may be beneficial for smaller organizations – it allows each therapeutic area to establish processes and reporting mechanisms that apply specifically to their needs. Larger organizations with multiple specialty areas conducting research, though, leave themselves open to a variety of risks, shortcomings and burdens.
The lack of standardization and centralized oversight under this model creates opportunities for increased risk of exposure for the organization, as a whole. With multiple sites negotiating their own budgets, defining their own contract language, managing their own finances and establishing their own processes, there are many ways an organization can fall outside of compliance, or leave money on the table.
The financial impact alone could take a heavy toll on the organization as clinical and administrative positions will be duplicated across multiple specialty areas, adding unnecessary FTEs to an already overburdened budget. The flip side of this is that the study coordinator for each therapeutic area handles all administrative tasks. Taking on these extra responsibilities keeps them from focusing on revenue generating tasks, such as patient recruitment.
The Centralized Model is designed to avoid many of the concerns generated by the Decentralized Model. As the name denotes, the Centralized Model creates a centralized research administration, or Office of Research Administration (ORA), housing all administrative tasks while providing oversight and direction for each therapeutic area.
As seen in the model below, administrative tasks such as regulatory processing, pipeline development, process development and revenue cycle management are all managed by the ORA. There is no need to duplicate administrative FTEs, lessening the financial burden clinical research may have on the organization.
In the Centralized Model, coordinators are hired by, report to and are paid by the central administration. They are then placed with the investigators, working side-by-side to focus on patient-centric and revenue generating tasks such as patient enrollment.
The Hybrid Model shares qualities of both the Centralized and Decentralized Models. As in the Centralized Model, the central administration, or ORA, works in much the same capacity, managing and overseeing all administrative tasks associated with clinical research within the organization. Coordinators, however, are hired by, report to and are paid by specialty service line management within each therapeutic area (generally a service line administrator or the investigator).
The Hybrid Model offers the stability of the Centralized Model, while providing the flexibility and autonomy for each therapeutic area that can be experienced with the Decentralized Model. As an added bonus, the Hybrid Model allows service lines to be added or eliminated for any reason without changing the model or disrupting the ability of the organization to conduct clinical research.
Both the Centralized and Hybrid Models benefit from the management and oversight of administrative tasks provided by a central research administration, which lowers the possibility of compliance risk. Both also benefit financially by reducing the need for duplicative administrative FTEs within each therapeutic area. Study coordinators are not overburdened with administrative tasks, and can focus on patient enrollment, which wins more sponsorships through the research program meeting enrollment goals.
The lowering of these financial risks and bolstering of revenue generating efforts created by the use of either model will assist the research department in meeting financial goals, providing opportunities to offset most, if not all, costs associated with conducting clinical trials.
For more information about clinical research site structure models, or if you would like to discuss how GuideStar works with healthcare research sites, contact us.
GuideStar’s research team has years of experience with clinical research program site structure, staffing, finance, compliance and communications. Our services include structural and financial evaluation, budget negotiations, coverage analysis services, and more.