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
such as The Cleveland Clinic, 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, 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 is co-developing
a vasopressive agent
for the
treatment of hepatorenal
syndrome. In addition to
managing this entire clinical
program, 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.