Ginger Gargas's Contact Details

Ginger Gargas's Company Details

EmpiraMed

Maynard, MA, US • 20 - 49 Employees
BioTech/Drugs

EmpiraMed is a digital health technology company that performs post-market, prospective, Virtual Clinical Studies to generate Real World Evidence for the Life Science Industry. We sit at the intersection of DCT (Decentralized Clinical Trials) and RWE. Formed in 2011, we pioneered the methods and delivery of 100% site-less virtual studies. Our software products help manufacturers demonstrate real world value and comparative effectiveness to prescribers; produce evidence for expanding market access; deliver more efficient methods to meet FDA mandates for Phase IV Long Term Follow-Up studies; deploy patient-centered rare disease registries; and, support more rapid regulatory approval of new indications and label extensions using real world data. Our services are novel and differentiated through an automated rules-engine for agile study deployment; complete mobile device independence; the largest specialty pharmacy network for patient recruitment in the industry; a complete clinical research gamification and incentivization system to boost patient engagement; and, a patient-centered method of capturing clinic data without the burden, expense, or delays related to clinical trial research agreements. We are proud that our studies average 80% monthly survey compliance which is over 3X the industry benchmark for noninterventional clinical studies. Our software and services are internationalized, localized, and support all industry compliance requirements including HIPAA, GDPR, GCP, and 21 CFR Part 11. Our customers have included global biopharmaceutical leaders such as Merck Sharp & Dohme, Janssen, Sanofi Genzyme, and Takeda Oncology. We also have contracts with novel patient recruitment channel partners including leading specialty pharmacies such as CVS Health and Optum, international Patient Advocacy Groups such as LUNGevity, academic research centers, disease management call centers, and organizations to support direct-to-patient eRecruitment.