International HealthCare’s clinical expertise…your trial success
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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.
>>more details
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.
>>more
details
Rx OTC
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.
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