“HIC has an exceptional, nuanced understanding of the stringent regulatory requirements and standards expected in FDA-regulated clinical trials. HIC partnered with our team to ensure critical systems and processes are fit to purpose for complex clinical trials using novel technology by evaluating use cases for compliance with FDA’s good clinical practice (GCP) requirements, human subject protections, submission standards, and data reliability. HIC’s approach also enhanced our quality system and increased our efficiency through standardization of protocols and procedures. We are very grateful for HIC’s in-depth knowledge and commitment to our company’s needs. What an impact!”

— Josh Buddle, Director, Clinical Operations, Flatiron Health

“HIC has been instrumental in guiding us towards greater success in collaborating with federal entities like military health and the VA. Their expert advice and actionable strategies have significantly enhanced our engagement and impact within these critical sectors. The unique and highly skilled team at HIC stands out, providing unparalleled expertise and support, leading to increased market uptake and provider utilization.”

– Chris Burton, Enterprise Account Director, Exact Sciences

“As an international multinational company navigating the complex landscape of FDA regulatory requirements, we faced numerous challenges in attaining regulatory clearance for one of our key products. Partnering with Healthcare Innovation Catalysts was a game-changer for us. Their deep expertise and strategic guidance were instrumental in overcoming significant hurdles, ensuring our product met all necessary criteria for clearance. They have subsequently introduced novel ways of dealing with regulatory complexities, providing innovative solutions that set them apart. We are grateful for their strong support and look forward to continuing our collaboration with them.”

– Mike O’Connell, President, Nikkiso Medical America, Inc.

“HIC was able to provide exactly what we needed – an understanding of federal government processes as they applied to us and connections to all the right stakeholders. HIC’s tactical and strategic multidisciplinary advice was informed by deep understanding and experience in the federal system, and it was pivotal. HIC’s consultants are expert, informative, and adaptable. I wholeheartedly recommend the team.”

– Sal Mascia, Chief Executive Officer, Continuus Pharmaceuticals 

“As a spin-out from a university and start-up device company, it was crucial for us to identify the most efficient, cost-effective path to bring our software from an idea through clinical development to FDA authorization. HIC evaluated our regulatory pathway and developed a unique strategy for regulatory clearance, communicating these findings to investors, and then executing on the work, including biostatistical analysis, development of a quality system, clinical study report, and our regulatory filing. HIC was very knowledgeable, flexible, and cost-effective in its partnership with us. Throughout the process, HIC experts made themselves available to answer questions and provided detailed, actionable approaches to meet our needs.”

– Dean Papadopoulos, Board Member and Chief Strategist, EpiWatch

"Partnering with Healthcare Innovation Catalysts (HIC) was crucial to strategically plan for engaging with the FDA. HIC’s expert regulatory, clinical, and biostatistics evaluations provided us with a clear and efficient roadmap. We are now able to better focus and accelerate our goals. We highly recommend HIC for their professional and insightful support. HIC’s impact on our business has been substantial."

– Tai Xie, Chief Executive Officer, CIMS Global

“After leveraging the knowledge of HIC experts, our clinical research site network significantly strengthened its collaboration with the agency and gained valuable insight into inspection status and FDA handling of findings. HIC’s profound agency and clinical trial expertise proved to be invaluable, offering a unique perspective that ultimately enhanced our team’s capabilities and improved our communication with the agency overall. HIC is unquestionably our first choice for guidance in the future.”

– VP of Regulatory & Quality Assurance, Clinical Research Site Network 

 “HIC provided amazing support for the Type C Meeting Package and Breakthrough Therapy Designation Request for our novel psychiatric drug. We truly appreciated their incredible insight and constructive feedback.”

– CEO, Privately-held Pharma Company