IHC Services

International HealthCare’s management team has extensive industry experience from both a CRO and Pharma perspective. Our knowledge and experience will ensure your study’s success and help pave the most efficient and effective clinical path for your product. International HealthCare seamlessly integrates today’s management technology (IHC’s Project Tracker System) with personalized service to provide the management support needed to complete your trial on time, within budget, and with quality data.

The International HealthCare (IHC) team of regional and in-house senior clinical research associates provides efficient site management throughout the United States, Europe, Latin America and Canada. We are well versed and experienced with Electronic Data Capture (EDC), including training the clinical site staff, and analyzing how these systems can be utilized to its fullest advantage assuring ultimate success. Our experienced CRAs understand the processes and most up-to-date regulations required to effectively manage the investigators and study coordinators. Most importantly, IHC’s CRAs interact with our sites and clients with the respect they deserve providing the service necessary for success.

International HealthCare’s medical writers produce clear, concise clinical reports, abstracts, publications and regulatory submission documents that are scientifically and medically accurate and written to fit the sponsor’s needs. Your project begins with our thorough review of your clinical protocol, and ends with an integrated clinical and statistical report ready for inclusion in your regulatory submission. Our procedures for reporting clinical data are fully compliant with FDA/ICH regulatory guidelines.

International HealthCare provides comprehensive biostatistical services that meet all your project needs. To assure compliance to statistical standards and maintain strict audit controls, all clinical data is inputted, data managed, and statistically analyzed via an approved SAS based database system. Our biostatisticians are experienced in a broad range of therapeutic areas and adhere to our standard operating procedures ensuring global consistency and quality of deliverables.

International HealthCare’s (IHC) regulatory strategy and compliance with FDA/ICH guidelines helps our clients bring their new products and new product claims to the market with an unparalleled success rate. IHC’s Executive Team has over 45 years of proven success in managing clinical programs. They have been instrumental in designing and managing pivotal trials that have led to new product claims and NDA approvals, including 10 successful RX>OTC switches. Our team manages site regulatory documents with both paper and electronic processes, and our document management process ensures no 483s and compliance with good clinical practices.

International HealthCare (IHC) provides and manages all services relating to trial safety review and adverse event monitoring. We have extensive experience managing Clinical Event Committees, Data Safety Monitoring Boards, and central or local IRBs. IHC has the expertise to convene effective and efficient safety review committees by identifying those experts who have long-term experience participating in these committees. Selecting the right individuals to review and manage the safety events of your clinical studies is just as important as selecting the right investigators to conduct your studies. IHC prides itself in staffing these committees with those individuals who are the most appropriate for your clinical program.