Musculoskeletal Clinical Regulatory Advisors, LLC
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading advisory firm to the neuro-musculoskeletal industry with growing experience in other specialties. Founded in 2004, MCRA is headquartered in Washington, DC, with offices in New York, NY, and Manchester, CT, has more than 50 team members, and serves over 400 unique clients globally. The true value of MCRA is the integration of six business value creators for orthopedic & other medical/surgical specialties: regulatory, reimbursement, clinical research, intellectual property, compliance, and quality assurance. MCRA provides “first-in-class” services through its superior knowledge base, global surgeon and physician relationships, and deeply experienced management team. Additionally, MCRA recently started Specialty Healthcare Advisers (SHA), which specializes in healthcare provider consulting.
MCRA’s many years of expertise in clinical, reimbursement, regulatory and compliance to provide our clients with a unique 360? integrated perspective. Depending on client needs or goals, MCRA provides clinical trial enrollment strategy and data collection, regulatory strategy, submission and execution, specialty coding & reimbursement recommendations, RAC audit preparedness and defense, Medicare pre-determination assistance, and other services. MCRA’s core clientele are orthopedic spine and biologic medical device companies, private equity firms, CROs, and law firms, and we have an increasing percentage of clientele from other healthcare industries
MCRA’s Management Team has more than 150 years of combined experience in leading and providing services to a wide range of organizations in the healthcare industry, including the healthcare industry’s largest providers and companies, global manufacturers, and regulatory agencies. We are prepared to assist any healthcare industry client operate successfully despite the stressful dichotomies of our high-pressure healthcare system. MCRA’s regulatory and reimbursement team has reviewed over 1,000 medical/surgical regulatory submissions in numerous specialties; our clinical team has led, advised, and/or monitored approximately 100 various studies for the specialty clinical market; MCRA’s intellectual property experts have examined, drafted, prosecuted, and prepared pre-litigation materials for over 220 issued device and other patents and/or patent applications working for manufacturers and law firms; and the reimbursement team has led over 1,200 healthcare economic-related initiatives. Additionally, the staff has participated in three national study teams addressing major nationwide critical clinical issues for hospitals and long term care providers, and has worked on these teams with key medical opinion leaders, clinicians, medical school professors, national medical specialty society representatives and the J.C.A.H.O.
MCRA, LLC was formed in 2004 by the private equity firm Viscogliosi Bros., LLC (VB), a firm dedicated exclusively to creating, building, operating, and financing companies in the neuro-musculoskeletal industry. MCRA’s success incentivized VB to continue investing in professional services companies, encouraging VB’s four additional advisory firm follow up investments. MCRA is proud to be an industry leading advisory firm and a successful venture for the VB team.