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The perspective of the site as a silent partner

Monday, August 24, 2015

The Pulse on Site Success by Jeffrey Adelglass

If it has not become apparent to you over the last few years that the landscape is changing regarding the importance of a perspective site’s offer to sponsors and CROs, then one might infer you are missing the opportunity to better position your site for recognition and success.

The perspective of the site as a silent partner has changed dramatically and many industry leaders are engaging sites much further upstream in the research process to better position the studies we perform for success, and to therefore provide better successes for sites overall.

As long as five years ago, Quintiles—after determining how a “little extra contact” with investigative sites improved study startup times by 20% and enrollment jumps by up to 100%—began hiring strategic site relationship managers (SSRMs). This model has expanded to exponentially include SSRMs worldwide.

It is impossible not to notice the changing environment now fully loaded with individuals who weigh in heavily on site selection and seek our opinions more robustly. Many “titles” have surfaced that are notable, individuals charged with providing more emphasis on site relationships. Those new positions include job titles such as vice president or director, site and patient access; clinical site relationship and operations lead; or director of strategic site collaboration, to name a few. They often are seasoned industry veterans and have a good grasp of the importance of strengthening and aligning the long-term relationships with investigators, critical to the future direction of clinical research. These individuals are the new point of contact for issue escalation related to collaborations with sites, and provide global oversight and report to high-profile leadership. It seems logical that these individuals might be high on your list of people with whom you should form relationships, ultimately to better communicate your site’s particular expertise and experience.

Let’s take the concept a step further and reference how these new teams are tasked to focus on key indicators at sites, effectively ranking sites and developing performance parameters of we all should be aware. Many of the job descriptions for these site relations managers includes defining and reporting key performance indicators (KPIs) through review of site metrics and trending analyses.

In a recent job description available online, Roche included the following statements related to the responsibilities of a clinical site relationship manager: “influencing without authority; tactfully guiding internal and external teams to improve study startup times; advising and leading complex negotiations from a strategic viewpoint. The CSRM (clinical site relationship manager) will also be accountable for collating information, presenting relevant data, advising on trends and observations and making strategic recommendations to leadership. The CSRM will influence the pharma development portfolio budgets in excess of tens of millions of dollars.”

I would say this brings a particular “wow factor” to the table, in terms of my business development plan. Not only is this element of the relationship important in respect to garnering new business opportunities, but I also want to strive to know firsthand what these leaders are thinking, analyzing and planning to liaise with me about! I think of this new model as a reciprocal arrangement, as our partners want to know more about us and we want to know more about them.

According to a recent report by Tufts (as covered by Zachary Brennan of OutsourcingPharma.com in February), a CRO suggested to Tufts that strategic site relationships are conducting a paradigm shift in site management because strategic partnerships between sponsors and CROs are adding to CROs’ responsibility to manage sites and select them for participation: “Sites that want to build their businesses over the medium to long term are responding by adopting the best practices, including better management of data and investing in their relationships with CROs.” The report also states that the improvement of investigative site relationships is a top priority for pharma and CROs alike in 2015.

Let’s get on this bus and continue to seek out opportunities to make the right connections and recognize that our opinions are considered essential. Let’s make sure this is not just another trend in the clinical trials arena. Let’s “seize the day,” as they say! 

 

Jeffrey Adelglass, M.D., F.A.C.S., is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multisite, multidiscipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed more than 1,800 clinical trials in multiple disease areas. Email comments and questions to jeffadel@gmail.com.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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