Project Management
International HealthCare’s project managers have 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.

Site Management/Monitoring
The International HealthCare (IHC) team of regional and in-house senior clinical research associates provide efficient site management throughout the United States, Canada and Mexico with a regional network strategically placed in New Hampshire, Pennsylvania, Virginia, California, Texas, Alberta, and Acapulco areas.

IHC reduces cost and increases quality regardless of geographic study site placement. IHC’s advanced technology communication system allows immediate Web conferencing that speeds the process and increases the accuracy of the data.

We are well versed and experienced in the nuances of Electronic Data Capture (EDC), in how to train the clinical site staff, and how to utilize it to its fullest advantage assuring its success.

Our experienced CRAs understand the processes and 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.

Problem Solvers - IHC "S.W.A.T." Visits
We have solutions for your major problems. If you have Slow Enrolling Sites, CRF data which is slow getting entered, reviewed and cleaned, Sites not getting activated or implementing Protocol Amendments, or Study Coordinators and Monitors who are slow in resolving problems, find out how IHC can help you resolve these and many other leading issues of a clinical trial. Click on the "more details" link to find out more on how we can help save your trial.

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Data Management
International HealthCare (IHC) provides real-time, quality data management by effectively utilizing our staff’s expertise with SAS based software and industry compliant strategy. The generation of clean data also requires an emphasis on communication, both internally and with the sponsor, which we support through our technology and standard operating procedures (SOPs). IHC focuses on the sponsor defined data handling requirements to produce fast, accurate, and cost efficient end results.

Medical Writing
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.

Biostatistics
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.

Regulatory Affairs
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 principals have over 30 years of proven success in managing clinical programs that achieved 9 successful RX OTC switches. They have been instrumental in designing and managing pivotal trials that have led to new product claims and NDA approvals. Additionally, our regulatory division, Global HealthCare Partners, is positioned and staffed to help you plan your regulatory strategies and manage all your regulatory filings.

Safety/Ethics Review
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 and your product’s viability.

Product Development
International HealthCare (IHC) researches and identifies new products and technologies for sponsor companies with support from our sister company, Global HealthCare Partners (GHP). Our partnerships and alliances offer a full array of development service that allows IHC and GHP to develop, file, test, manufacture, and plan the market introduction of a wide breadth of new products.

Training
SOP’s, work instructions, in-house training, and industry sponsored courses are all an integral part of International HealthCare’s (IHC) training program. Our program provides the foundation and advanced training required to conduct compliant clinical trials. Our staff’s training is continuous which benefits the clinical process as well as the integrity of the data. IHC values the importance of skill development through documentation, training and experience. Our training program is designed to deliver smooth running clinical trials that are compliant with good clinical practices and all ICH and FDA guidelines.

Communication
International HealthCare (IHC) employs state-of-the-art online communications technology that allows the client to be an integral part of the clinical trial process every step of the way. This technology provides interactive Web conferencing that is immediate between the client, IHC, and the clinical site staff…simultaneously – any time – any place.