Press Release

MediMergent and the FDA Sign Five Year Collaboration Agreement to Continue Collection of Patient-Centric Real World Evidence

October 9, 2017

Rockville, MD –

Healthcare data integration and analytics company MediMergent LLC (The Company) and the Center for Drug evaluation Research (CDER) of the U.S. Food and Drug administration (FDA) have signed a five-year Research Collaboration Agreement (RCA) to continue the development of data collection and analytic tools for real-world evidence (RWE) using the Company’s proprietary platform, the National Medication Safety Outcomes and Adherence Program (NMSOAP).

The NMSOAP, established under the Company’s initial RCA with CDER, completed a 10,000 patient proof-of-concept evaluation of patients treated with novel oral anticoagulants or standard of care for the prevention of atrial fibrillation (AF) related stroke, deep venous thromboembolism, or pulmonary embolism. The NMSOAP combines Patient Reported Outcomes (PRO) collected in the voice-of-the-patient with physicians’ medical records, medication prescription data from pharmacies, and health insurance claims data. The NMSOAP determines longitudinal risk-related profiles on disease management and treatment, medication adherence, patient safety, clinical outcomes, drug effectiveness, REMs, and comparative effectiveness.

Kenneth Borow, MD, President and Chief Medical Officer of MediMergent stated, “The renewal of our RCA continues our commitment to the FDA to bring cutting edge technology and analytics to the post-approval process. Our integrated patient centric approach analyzes data produced from all stakeholders who influence the patient’s health care journey and broadens the definition of RWE beyond a limited focus on claims data. New legislation (PDUFA VI and the 21st Century Cures Act) requires the use of RWE in the drug approval and commercialization process. MediMergent’s NMSOAP platform is well positioned to help biopharma and payers meet these requirements by creating an ecosystem that empowers patients to become more integrated members of their health care team. This includes efforts to enhance medication adherence/persistence, provide information that could identify early warning signs of potential adverse events, and open communication pathways among patients, caregivers, providers, pharmacists and health insurers.”

About the NMSOAP

The NMSOAP generates near real-time real-world evidence directly from patients who enroll through an efficient-point of-care approach that includes pharmacies, infusion centers or physician offices. The NMSOAP’s proprietary analytics uses cognitive intelligence to enable data sources to be adjudicated for discrepancies and to ascertain the “truth.” MediMergent prospectively enables biopharma and payer sponsored projects to efficiently translate real world data into patient centric real-world evidence.

About MediMergent, LLC

MediMergent is a leading Real-World Data and Evidence (RWD/RWE) company combining patient engagement, digital technologies, and predictive analytics to collect, integrate and interrogate Real-World Data from the context of the patient. The Company’s digital platform leverages the power of the patient’s voice to provide accurate, reliable, and comprehensive data with the goal of improving health outcomes and compliance to treatment. MediMergent delivers the Voice of the Patient through a suite of digital applications and proprietary surveys that engage directly with the patient. These data are combined with advanced technologies including AI, ML, and predictive analytics to collect, integrate and analyze Real-World Data that brings real-world impact to Real-World Evidence.

To learn more about MediMergent’s Real-World Evidence solutions, please contact them at


MediMergent Media
Jessica Beote
Matter Communications