MediTechnix and Clinical Research Strategies (CRS) 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.
“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,” Gene Monaco, CEO and Principal of MediTechnix said.
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” said David Link, MBA, Co-Founder and Chief Quality and Regulatory Officer of Clinical Research Strategies.