International HealthCare
International HealthCare (IHC) provides comprehensive clinical research services, regulatory strategy, and product development capabilities to the pharmaceutical, biotechnology, and medical device industries worldwide. With a focus on designing, monitoring, and managing all phases of clinical trials using sophisticated technology, IHC aims to ensure data integrity and facilitate successful product approvals. Their staff, research specialists, and regional monitors are located across the US, Europe, Latin America, and Canada, emphasizing a client-focused approach to achieve faster completion, lower costs, and greater data integrity.
Industries
Nr. of Employees
small (1-50)
International HealthCare
Norwalk, Connecticut, United States, North America
Services
Integrated project management using web-based tracking systems and dedicated project teams to deliver trials on time and on budget.
Regional and in-house clinical research associate services for site initiation, monitoring, training and closeout across multiple regions.
Preparation of clinical study reports, regulatory submission documents, abstracts and publications compliant with regulatory guidelines.
Comprehensive data management and biostatistical services using an approved SAS-based system with audit controls and quality procedures.
Regulatory strategy development and execution aligned to FDA and ICH guidance to support product claims and approvals.
Management of adverse event monitoring, DSMBs, clinical event committees and IRB interactions for trial safety oversight.
Integrated project management using web-based tracking systems and dedicated project teams to deliver trials on time and on budget.
Regional and in-house clinical research associate services for site initiation, monitoring, training and closeout across multiple regions.
Preparation of clinical study reports, regulatory submission documents, abstracts and publications compliant with regulatory guidelines.
Comprehensive data management and biostatistical services using an approved SAS-based system with audit controls and quality procedures.
Regulatory strategy development and execution aligned to FDA and ICH guidance to support product claims and approvals.
Management of adverse event monitoring, DSMBs, clinical event committees and IRB interactions for trial safety oversight.
Expertise Areas
- Clinical trial management
- Medical device clinical trials and device regulatory submissions
- Phase I–IV drug development
- Rx-to-OTC switch programs
Key Technologies
- Electronic data capture (EDC)
- SAS-based statistical analysis
- Interactive voice/web response systems (IVRS/IWS)
- Web-based project management/CTMS applications