Sponsor & CRO Services

All clinical trials at Mercy are centrally managed by Mercy Research to ensure compliance and quality throughout our health system.  We have over 700 active studies with more than 4,000 participating patients across 5 states.

Through our integrated and unified model, we offer our sponsors the full resources of the 10th largest health System in the U.S., personalized study management, excellence in Quality and Compliance, low deviation rates and efficient enrollment.  Mercy Research has collaborated with leaders in the pharmaceutical and medical device industry such as: Eli Lilly and Company, Celgene, Novartis, Roche/Genentech, Merck Sharp & Dohme Corporation, Novo Nordisk, Allergan, GlaxoSmithKline, Medtronic, Bristol-Myers Squibb, Pfizer, Abbott, Boston Scientific and many others.

Problem

Changing an industry from the inside out is not an easy task, especially one as large and complex as the world of clinical research. For decades, clinical trial research operations have been hampered by the slow and arduous task of identifying qualified Principal Investigators, and the even longer process of recruiting willing study subjects to participate in a given clinical trial. Clinical trials by their very nature are expensive undertakings and multiple studies have shown; delays in data acquisition related to slow recruitment of subjects cost pharmaceutical companies up to one million a day in lost revenue.

Solution

Mercy has a vision – a new sleek, modern and efficient system not in existence elsewhere. We term it a “Research SuperSite” ™. Gone are the days of having to track down suitable and interested Investigators one-by-one; attempt to recruit them individually with opportunities. All the while, working with a multiple of other support staff to complete the necessary regulatory, legal, budgetary and operational work necessary before a trial can even start. Mercy’s “one call connects you to all” ™ concept allows sponsors to make a single call to access all of Mercy’s vast assets, wherever those assets are located; and/or the ability to leverage multiple PIs across several states. Our 3,300+ integrated physicians and 24 acute care hospitals in 7 states serve over 3.2 million active patients and had over 8.7 million patient interactions in 2015 alone. Mercy was also an early adaptor of the Epic EMR system, with electronic records dating back 8+ years.Mercy’s internal support structure includes a streamlined regulatory department,including a local IRB which meets 12 months out of the year, a centralized data management team and a full-time dedicated patient recruiting team. This allows our Clinical Research Coordinators to focus on doing what they do best, giving study subjects novel and innovative care, ensuring subject retention and being completely focused on maintaining the lowest deviation rate in the industry.

Differentiator

Sponsors who want to roll-out a clinical trial of any substantial size have two choices. Engage large academic institutions one at a time, knowing that a potential concentrated patient population exists, but is lacking any geographic dispersion. Then, wait months for internal regulatory and contract hurdles just to get access to one or two PIs. Or, in the alternative, engage a third-party CRO to attempt to locate multiple small sites, wait months for each site to negotiate individual contracts, budgets and regulatory approvals, only to find out that on average 20% of sites never even enroll a single subject and 30% of sites only enroll 1-3 patients per a study. The answer is the Research Super Site™ and Mercy is the first and only large institution in the US with the ability to roll-out a trial to multiple states (up to 7) and/or multiple internal PIs, while only negotiating one contract and one budget. All regulatory is overseen by one internal (local) IRB and can be approved in as little as 45 days. Mercy is also the only institution of its size that has vertically integrated and centralized its legal, compliance and recruiting under a single unified leadership structure. What does this mean for sponsors?  45 day start-ups at
up to 10 different locations upon a single budget and contract approval. A single point of contact for all things regulatory and a centralized recruiting effort that leverages Mercy’s 3.2 million active patients in 7 central US states. Sponsors can count on clean usable data, quick FPI and large recruiting numbers, which can only come from Mercy’s vertically integrated research institution.