The
staff and management at IVRCC have substantial experience
in all types of clinical studies.
Management Team and Advisors
The staff and management at IVRCC
have substantial experience in all types of clinical studies:
from Phase I to Phase IV trials; from single-center
studies to inter-continental trials involving
thousands of patients. The combined experience of the IVRCC
staff is well over 35 years, with Interactive Voice response
experience in 200+ clinical trials and growing:
Since its inception, IVR Clinical Concepts'
growth has been monitored by an International Advisory Council
composed of individuals with broad experience in all the
aspects of the clinical research process, and with specialization
in the development and utilization of Interactive Voice
Technology in clinical environments.
Advisory Council:
Victor Strugo, President Triclinium
CRO, South Africa - Mr. Strugo has been involved in
over 400 clinical trials from the industry, site and
CRO perspectives. He brings to the Council experience
as an IVRS user rather than developer. In 2000 he founded
the South African-based CRO Triclinium, which has set
up and monitored several multicentre trials across many
countries in sub-Saharan Africa, a region where local
communication technology can be the major challenge
to overcome before IVRS and web-based systems can be
effectively deployed.
Dr. Patrick McGrath, PhD, Vice
President Research and Development, Morton Grove Pharmaceuticals
- Dr. McGrath's training includes a BS in Pharmacy and
a Ph.D. in Pharmaceutical Sciences / Pharmacology from
the University of Missouri-Kansas City, in 1978 and
1991 respectively. Since 1980 he has been involved in
the broad range of drug development activities under
GCP and cGMP regulations. His Phase II-IV clinical and
regulatory product development work includes significant
NDA and ANDA experience with additional medical device
exposure. Notable NDAs include those for IV Nitroglycerin,
Sucralfate Tablets long term therapy, Sucralfate Suspension
NDA, Chlorhexidine Gluconate 1% in IPA 70% topical solution
for indwelling catheter insertion and maintenance, Apomorphine
HCl injection for late stage Parkinson's Disease, long
term phase IIIb/IV safety studies for mesalamine and
other projects. Notable ANDA experience includes fluticasone
propionate nasal spray. Notable medical device experience
includes the successful defense of a request for designation
confirming the classification of Sucralfate HCl Topical
Paste™ as a medical device while all other forms
of Sucralfate remain regulated as drugs. FDA market
clearance of Sucralfate HCl Topical Paste™ was
then achieved under 510(k).
Gregory J. Bailey, President,
Bailey & Associates - Mr. Bailey specializes
in developing programming solutions for a variety of
firms. His company has developed FDA audited database
interrogation software for contract research organizations,
corporate relations management software for universities,
time management and membership tracking applications
for several organizations. He has previously worked
as a senior programmer for Mathew Bender and Associates,
Glens Falls Hospital, Fleet Financial, and Digital Equipment
Corporation.
Dr. Lawrence Reiter, PhD, Managing
Director, Criterium , Inc. - Dr. Reiter has experience
in both pharmaceutical and CRO organizations. His extensive
global experience enables him to communicate and assist
with a wide range of clients and clinical sites in South
Africa. In addition to South Africa, Dr. Reiter has
managed clinical studies in the United States, Europe,
Eastern Europe (including Russia), Australia, and other
African nations. He has experience managing HIV/AIDS,
sepsis, malaria, infectious disease (herpes, pneumonia),
GI, oncology, cardiovascular, pulmonary, and allergic
rhinitis studies. Dr. Reiter also is well known in South
Africa for his role in training sites and industry professionals
in Good Clinical Practices.
Clients who choose IVR Clinical Concepts
for their Interactive Voice Response solution do
are rewarded for their trust in our ability to develop and
implement customized and effective processes that fulfill
their need for a flexible and cost-effective answer that will
“Get to the Heart of the Data.”
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