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.
Closing Thoughts.
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.
Special Thanks
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 sreuter@gwu.edu or 203.775.6031.
{ 7 comments… read them below or add one }
More research networks are forming in various ways to take advantages of changing models of clinical research and efficiencies. I noticed today the Alliance model, specifically, the Alliance for Multidisciplinary Research. They made it a point to say that they are not an SMO, they are an Alliance where member research sites pay dues to be part of the network. I suspect this is not new but becoming more popular.
Hi Mike,
Thank you for this information. I would be interested to hear more about the model you mention, why sites pay to be part of a network, and why this might become a more popular model.
Kind regards,
Sherry
ISN, TMO, SMO, Alliance, etc. What are the differences, really? Bringing together a group of typically independent sites under an umbrella where efficiencies can be leverages. That might be, SOPs, BD or may extend to other offerings.
The key, in my opinion, is the realistic offering of sites within that entity to industry for any given study. The old SMO model was built of thinking one entity could provide all the sites needed. Well, we know this didn’t and doesn’t work. At RxTrials we carefully evaluate each study and match it with the right site(s) within our network. One study does not fit all sites, even those sites in the same network. If thought is given to being precise in the selection of sites – be it within a network or a solo site selecting a study- enrollment goals will be met, the site will flourish allowing it resources to continue to enhance the quality it’s delivering and ultimately the site will get more opportunities. But the real prize is in the end the patients will get the drugs/devices/biologics they’re in need of.
So regardless of what type of “community” your site lives, selecting the study carefully is the key to ensuring you’re invited to stay in the clinical research community.
Christine,
There are some differences in what certain groups offer sites that can make a major difference to the sites, their performance (and thus their value to sponsors) as well as sites’ business status. For instance, some groups provide helpful services to sites such as training, assisting with patient recruitment plans and offering support to overcome recruitment challenges.
I would be interested to hear from sites what they value (and would find valuable) from an umbrella organization.
Sherry
What about an Alliance of Site Networks? A network of Site Networks! That’s where the power is. Or even better – a network of Site Networks with sites comprised of investigator/practicing physician networks! WHOA… call me.
Hi dear colleagues!
I have read all of your interesting comments and the responses from the author; in our site we have made a very flexible agreement, making a site technical cooperation and assessment the keys activities.
Regarding the payment; there are not incorporation fees for joining to our network. Referring to the profits, each study budget is centralized in our site managers board; sites who make more activities such as investigators/crc participation and subjects enrollment get more money; this kind of competition, joint to the standard of quality we think have improved our performance
Dear Dr de la Hoz Gomez,
You mention that your sites receive compensation based on specific performance parameters such as enrollment. It makes sense for both the sites and organization that performance is as good as possible. Toward this end, I would be interested in the types of support organizations (everyone, please respond about your organization) give to their sites. For example, is Patent Recruitment and Retention support given to the sites?
Kind regards,
Sherry