What type of site are you?
There are many types of study sites and business models they work under. Do you know what they all are, what their differentiating features are, and under what circumstances each type might (or might not) be advantageous to you when selecting sites?
Are you an ISN?
One type of group is the ISN. Have you heard the term “Independent Site Network” and wonder what it is? It is not an SMO… but rather a flexible business model made up of independent clinical research sites. It allows each Investigator and Site Management team to select studies that are most suitable for their demographics and clinical areas of expertise. Studies are conducted with trained and certified clinical staff under standardized SOPs. This flexible model also allows for a variety of sites to work under the same corporate ISN umbrella (such as private practices with research staff, dedicated research sites with full-time research teams, phase I unit, Urgent Care, or other specialty centers.)
A sponsor can choose to use one or more of an ISN’s sites. If more than one site is utilized, documents can be shared (CDA, CTA, Budget, Source Documents, advertisements, and others). Coordination of these items is usually done at a central location. If a sponsor/CRO elects to work independently with each site, then all processes are dealt with at the site level. The key to this model is flexibility to fit the needs of the Sponsor/CRO.
Beyond contractual and regulatory convenience, this flexible model affords movement of each project at a quick pace. Several quality sites can be selected at one time, streamlined communications saves time, with contracts and regulatory documents usually resolved within 2 weeks. In addition the sites can lean on each other for support throughout the study.
This flexible site model is gaining in popularity as it fits nicely with the shifting “preferred provider models” and rapid changes in pharmaceutical, device, and diagnostic R&D services.
An ISN might provide convenience and efficiency for sponsors or CROs to work with in some situations. Other types of business models might be the right fit for others. Let’s hear from others about theirs.
Thanks to Michelle LaPage and Mary Raines from Research Across America for providing information. For more information, call Michelle at 763-208-8199 or visit www.researchacrossamerica.com.
About the Author
Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at email@example.com or 203.775.6031.