International HealthCare (IHC) has the staff expertise necessary to manage all drug, device, and tissue trials. We have the expertise and experience to design your entire clinical program, implement, monitor and complete the studies, analyze the data, and report the results for regulatory submissions and publications.
International HealthCare (IHC) has managed the entire clinical program of several cardiovascular medical devices from direct stenting and drug-eluting stents, spine stabilizing devices, to the development of a vascular device to treat varicose veins.
Medical device trials require an added level of specialized service and regulatory knowledge to be executed successfully. IHC understands the regulations required for PMA and 510K submissions, and therefore can assist your project team in designing the scope and breadth of those clinicals necessary to succeed.
International HealthCare provides full clinical research services, regulatory strategy and submission guidance as well as full product development capability to the pharmaceutical, biotechnology and medical device industries worldwide.
Our company designs, monitors, and manages all phases of clinical trials; utilizing sophisticated, state-of-the-art technology to ensure data integrity. We manage the total clinical trial process. We integrate our regulatory guidance and strategy to design the most efficient clinical plan that will culminate in successful marketing of new claims and new FDA approvals.
Our staff has designed, implemented and successfully supported the switch of over 11 Rx products to Over-the-Counter status.
IHC has been providing the Strategic Consulting for several large Pharmaceutical companies. We have guided their Marketing, Clinical and Regulatory groups through the maze of specially designed clinical studies enabling them to bring their products to the marketplace.
