Pittsburgh Companies Partner on Life Science Clinical Development

Two privately-held, Pittsburgh, Pa.-based companies, MediTechnix Incorporated and Clinical Research Strategies LLC, a boutique contract research organization (CRO), have announced a strategic partnership in life science clinical development that addresses software as a medical device (SaMD), wearables, blockchain, and digital health applications in conjunction with IND-enabling development programs of drugs or biologics, and IDE-enabling development programs of medical devices. In response to the newer regulations in digital health, life science companies are evaluating their drugs, biologics, and devices more than ever before with a technological investment in patient-centric feedback and real-world evidence (RWE), which brings to bear key priorities of the 21st Century Cures Act and the age of data transformation.
 
According to Deloitte’s 2019 outlook on the life science industry, “new, emerging business models require acute awareness of the symbiotic relationships between drug, biologic, and device development coupled with a validated digital platform which will advance companies through their discussions with the FDA and other regulators, and more likely help companies change clinical practice, reduce healthcare costs, and improve market share,” said Alethea Wieland, co-founder and president of Clinical Research Strategies LLC.
 
Gene Monaco, CEO and Principal of MediTechnix stated, “Having undertaken several Top-20 pharma first-in-class initiatives in this arena since 2010, my firm is proud to forge our strategic partnership with CRS to work together for the benefit of small- and mid-size life science and technology companies that have a large stake in true innovation today, including as we further incorporate blockchain to improve speed, accuracy, and comprehensiveness.”
 
The combination of two companies working side-by-side on the digital blueprints of novel IND and IDE projects including regulatory and quality strategy, software and product development, clinical trials planning and execution, and market approval “demonstrates we are listening to what our clients want by providing disruptive solutions knowing that analytics have a projected growth from $19B today to $33B by 2024, including in clinical research” asserted David Link, MBA, co-founder and chief quality and regulatory officer of Clinical Research Strategies LLC.
 
Since 2010, MediTechnix has executed numerous first-in-class turnkey enterprise transformational and innovative technology works and strategies extending from ideation, business architectures, and pro-formas, to PoCs, and complete implementations, including blockchain, SaMD, in-vivo biosensors, wearables, robotics, and virtual doctor visit, some winning major industry awards for true practical innovation. Recent clients include private investor startups, through blue chips including Cleveland Clinic, Biogen, Johnson & Johnson Medical Devices (Depuy Synthes), United Healthcare, Optum, American Red Cross, Grady Health System, Express Scripts, CVS Health, Genentech-Roche, Highmark, Wellcare, and Allegheny Health Network.
 
Clinical Research Strategies LLC is a private, U.S.-owned and operated, on-demand contract research organization and management consulting firm for the life science industry, founded by veteran leaders, Alethea Wieland and David Link, and supported by a multi-disciplinary team. Recent clients include digital technology and IT healthcare analytics startups, and small and mid-sized life science companies in regenerative medicine, orthopedics, trauma, oncology and immuno-oncology, women’s health, CNS, and pain indications, with special attention in class II and III devices.
 
Wieland contributes to initiatives on blockchain, interoperability, EU MDR, and RWE. She has 30 years’ experience analyzing the intersection of healthcare innovation and policy, meeting with the FDA, and facilitating accountable sponsor-CRO partnerships. She also serves as an advisor to healthcare IT startups eSimplify Solutions, Root Health, and Clinical Platform.
 
Link is a leader with 30 years of progressive accomplishments in quality engineering, quality assurance, and quality management with market-leading technology and medical device manufacturers. His career includes managing customer quality satisfaction and improving profitability by identifying critical priorities, marshaling commitment, and managing cross-functional teams to successfully execute corporate directives.