IHC’s staff is comprised of experts in many different therapeutic areas.
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, we provide the highest quality study management and monitoring service that any CRO could offer.
With overwhelming success, IHC helped complete a 200+ center, 6000+ patient PCI/Cath Lab study for an anti-thrombolitic. The trial utilized an electronic CRF and enrolled patients in over 17 countries. IHC was responsible for the trial monitoring, data cleaning, regulatory document management, and FDA audit support in North America.
With the use of electronic data capture and other monitoring tools, IHC has supported major concurrent clinical programs.
We have supported numerous cardiovascular programs with studies ranging from small pilot trials to the largest ACS trial in history. The following is a brief summary of some of our major cardiovascular programs to date:
- CABG – IHC has been responsible for project management, monitoring, data cleaning and regulatory management of a 4 trial CABG program. This program uses electronic data capture and includes both On-Pump and Off-Pump surgical technique. Subsets of patients also include HIT/HITTS diagnosis.
- ACS – IHC has provided project management, monitoring and regulatory management support to a 400 center, 13,800 patient ACS trial. The trial utilizes electronic data capture and is recognized as the largest ACS trial in history. IHC works with some of the most prominent institutions to support such large trials, such as the Cardiovascular Research Foundation and Lenox Hill Hospital.
- Diabetes – Small pilot work has been conducted with Type II diabetes medications and the correlation to cardiovascular disease. IHC staff has provided the monitoring and management of this breakthrough trial.
- Endovascular – IHC has provided the critical support for one of our clients to expand their indication for therapeutic drug use into the endovascular area including; renal, iliac, and femoral arteries.
- Hepatorenal Syndrome – IHC has co-developed a vasopressive agent for the treatment of hepatorenal syndrome. In addition to managing several large-scale multi-study clinical programs of over 80 major GI/Nephrology centers throughout North America, we have been working with the management of this company (that specializes in Orphan Drugs) to assess and plan for new and more extensive claims for their drug.
- ECCO2R – IHC has supported this IDE program to establish the safety and efficacy of an investigational Class III medical device for FDA pre-market approval (PMA) via a pivotal RCT to scientifically validate the indication for its use in acute exacerbation of COPD. Over 40 critical care respiratory centers (ICUs) were managed for this program.