Cardiovascular Profile
Rx to OTC Switches

International HealthCare’s clinical expertise…your trial success

International HealthCare (IHC) has the staff expertise necessary to manage all drug, device, and biologic 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.

Cardiovascular
We have established ourselves as the CRO of choice for cardiovascular research. With highly experienced clinical researchers coming to IHC from world renowned cardiovascular institutions such as The Cleveland Clinic and Duke Clinical Research, we provide the highest quality study management and monitoring service that any CRO could offer.

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Infectious Diseases
IHC's clinical staff of over 65 researchers is comprised of experts in many different therapeutic areas, including Infectious Disease. Our clinical researchers are from top Pharmaceutical and CRO organizations providing the highest quality study management, monitoring and data management services.

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RxOTC Switches
The International HealthCare staff has domestic and international experience in nine successful switches, including Gyne-Lotrimin®, Mycelex®, Nicorette®, Imodium-AD®, and the H2-antagonists (Pepcid-AC®, Zantac-75®, Axid-AR®). We work with our clients to identify new products ideal for the OTC market while providing these clients with a full understanding of the steps required to achieve an FDA and/or EMEA approval. We have also provided marketing and new product claim support for OTC products.

Pain Management
International HealthCare has significant staff experience in the areas of opioid and analgesic pain research, including adult and pediatrics. Our extensive investigator database and trial expertise ensures successful trial completion. Given the recent publicity surrounding opioid drug abuse and diversion, it is critical to use a service provider that understands trial nuances and the requirements of proper patient treatment.

Medical Devices
IHC has managed the entire clinical program of several cardiovascular medical devices from direct stenting and drug-eluting stents, to the development of a vascular device to treat vericose 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.

Gastroenterology
The International HealthCare staff has conducted major clinical programs for the H2-antagonists, antacids, PPIs, and various other GI products. Our broad experience covers the full range of study designs (In-Use, provocative meal, motility, ulcer, IBS, GERD…).

Oral Care
International HealthCare's staff has designed, implemented, and managed a wide range of oral care trials. We have full clinical program experience conducting dentifrice, chewing gum and denture adhesive studies covering such indications as hypersensitivity, extrinsic stains and whitening, as well as caries. We also have extensive experience providing marketing claim support and new methodology studies for these and other oral care products.

CNS
International HealthCare’s management team has broad experience in the entire CNS therapeutic area. Our staff was responsible for the project management, monitoring and closeout of an entire international program for a leading Alzheimer’s drug. This program involved multiple trials in over 450 centers in 18 countries. Our staff was responsible for the clinical monitoring, review, and data collection from each country, and for managing the quality control of all ongoing and closed data. We have experience designing and successfully implementing Web-based applications that provide total project management and quality control services. We have provided full quality control and auditing for a global 6000 patient, 450+ clinical site cardiovascular study. These services utilize Web-based audit tools and clinical review of the study data. Additionally, we train the clinical site staff on Electronic Data Capture (EDC) via iCRFs.

Biologics & Tissues
Providing regulatory strategy and clinical consulting, International HealthCare has pioneered the rapidly evolving biologics and tissues market. Our staff and expert consultants can help position and navigate your new product through the unchartered process of BLA & PMA approval.

Other Therapies
International HealthCare’s expertise covers a wide range of drugs and disease states, such as: cardiology, women’s health, neutraceuticals, dermatology and rheumatology. When success is critical, experience is mandatory.

Our experience…your success.




Norwalk, CT 06851
Ph: 203-852-8900
Fx: 203-852-1424


info@ihcresearch.com