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Mission Statement
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IMIC is committed
with clinical research of the highest quality standards, in strict
observance of international clinical practices guidelines and
regulations.
History of IMIC
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The Mexican
Institute of Clinical Research (IMIC) opened its doors in Mexico City
on March 1, 2000 with the intention of conducting high quality
clinical research in Mexico. IMIC was first planned, designed and
organized by Dr. Roberto Chiprut, and Dr. David Ginsberg, as
professional consultant.
At the time, Dr. Ginsberg cited three primary reasons for the
formation of IMIC. The fact that there is a very large population base
in Mexico and throughout Latin America: that 12% of global drugs are
marketed in Latin America and would be best served by a population in
which the drugs are tested; and the FDA-driven emphasis on testing
drugs in people that portray real-life populations, not just male
Caucasians. “We believe that well-run clinical research in Latin
America will succeed”, said Dr. Ginsberg. “Our intention is not to
build (a center) as good as one in the United States, but a better
center”. (CenterWatch
May 2000 / Volume 7, Issue 5)
The original IMIC project, thought of as a clinical research center
for outpatients, rapidly grew into an institutional design that
includes not only the outpatient research center, but a whole
corporation that designs, organizes, and conducts multi-center
clinical research in the National Institutes of Health, and the
largest and best private and public hospitals and clinics. Education
has been an important aspect taken up by IMIC, with excellent results,
comprising international and local educational programs with
universities of acknowledged prestige.
IMIC consists of experienced, bilingual, full-time investigators and
coordinators. All of them are trained at active research centers. This
training includes a comprehensive review of GCP's, ICH and regulatory
aspects, among other topics. All employees participate in ongoing
internal and external education programs. IMIC also has its own IRB
and regulatory agent, as well as established relationships with the
Ministry of Health. All of these factors are fundamental to running
trials in Latin America.
Administration
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Experienced
medical and professional executives that have had the opportunity of
managing multiple activities in the medical industry in Mexico and the
U.S. integrate IMIC’s management group. Their goal is to develop a
unique clinical research entity in Mexico
with the
best local
and international industry standards.
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Adolfo Dorenbaum, BSBA (Chief Financial Officer)
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adorenbaum@imicresearch.com
Born in México, obtained his BSBA from
the Boston University, Boston, MA. He has spent many years as a
consultant setting up new ventures in Mexico City. He has extensive
experience in operations and financial management. He has participated
in the public administration privatization process, instrumental for
the modernization of Mexican economy. Presently, he is responsible for
IMIC's legal and financial related activities.
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Gina Gorodezky, MD (Chief Medical
Officer)
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ggorodezky@imicresearch.com
Dr. Gorodezky obtained her Medical
Doctor degree from the Universidad Nacional Autonoma de Mexico.
Was trained at M.D. Anderson Research Cancer Center as a Hemato/oncologist.
She has worked at the Cancer Institute in Mexico City and at the
Mexican Cardiology Institute. She has participated in multiple
clinical research studies in Mexico, USA., United Kingdom and
European Union.
- Laura
Gonzalez, MS (Director of Clinical Operations)
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lgonzalez@imicresearch.com
Ms. Gonzalez-Rossano is a Chemist
with a Master’s Degree in Science. She currently working as a
Project Manager on study protocols conducted with affiliated
hospitals in Mexico. Her duties are to assist and manage set up
trials with hospitals that IMIC contracted, and to maintain
compliance with study protocol procedures.
- Marc D. Russo,
(Business Development / Chief Technical Officer)
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mrusso@imicresearch.com
Mr. Russo is an experienced
entrepreneur, with a background of business set-up, organization,
and coordination in diverse commercial ambiences. He entered the
Clinical Research environment through one of his areas of
expertise, computer networks, website design and software, and
rapidly joined IMIC’s marketing and representation area. He has
designed IMIC’s company image, including its web page, in addition
to representing the Institute in business P-R.
Table of Organization
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Research Staff
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Mexico City, with
the largest medical community in the country, has experienced
physicians with backgrounds in clinical research in most therapeutic
areas. Although, clinical research in Mexico has not been fully
developed as in another countries in the American continent or Europe.
However, IMIC, with its experienced research staff. has created a
network of experienced investigators that have received adequate
training on ICH, GCP, and Local regulations to conduct clinical
trials. In addition, IMIC has established very demanding standards for
the investigators and sub-investigators that it includes in its
specialist database, and trains them in GCP and ICH, also. Therefore,
IMIC's investigator database will allow us to select qualified and
trained investigators to participate in any therapeutic area study.
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Laura González Rossano,
Chem Bact/Parasit/MMB, Project Manager
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Ms.
Gonzalez-Rossano is a Chemist in Bacteriology and Parasitology,
with a Master’s Degree in Molecular Biomedicine. She has a
research background in Neuro-Science in the National Politechnic
Institute (CINVESTAV), and Molecular Hepatology in the National
Institute of Nutrition. She is IMIC’s Project Manager for trials
in six Medical Centers.
Study Coordinators
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The study
coordinators are the key players in every study that is conducted in
IMIC. Therefore, IMIC has developed ongoing training programs in order
to maintain all study coordinators fully aware of the ICH and GCP
guidelines, and the Mexican regulations. In addition, the study
coordinator is responsible for the reviewing of all study specifics,
maintain the communication with the study team and the sponsor’s
designated personnel, and maintain all study events and records in
compliance with the study protocol and regulations.
Bioethics Committee
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IMIC is
supported by the first independent IRB in Mexico, which is composed by
renowned members of the Mexican medical and non-medical community. The
IRB conducts the review and approval according to their policies and
procedures, the study protocol, the Mexican regulations, and the ICH
and GCP guidelines.
Quality Systems
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IMIC applies all
principles of quality through its Quality Assurance department, which
has developed controls that monitor the effectiveness of the systems
and processes, and verifies the compliance with the study protocol and
regulatory requirements. This department also periodically reviews,
measures, identifies any deviations, and implements corrective actions
for the continuous improvement of performance.
Fact Sheet
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Original Conception: |
May, 1999 |
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Date of Incorporation: |
Oct. 1999 |
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Legal Structure: |
Mexican Corporation |
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Regulatory Permits: |
Jan. 2000 |
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Site Identification: |
Nov. 1999 |
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Site Renovation: |
Dec. 1999 – Mar. 2000 & Jun. 2003 - Aug. 2003 |
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Standards of Operation: |
Jan. 2000 – Mar. 2000 |
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Computerized Database: |
May, 2000 / Feb. 2003 (updated) |
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Initiation of Operations: |
April, 2000 |
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First Trial Initiated: |
May, 2000 |
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Trials Completed: |
27 (Sept. 2003) |
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Project Managers: |
2 |
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Study Coordinators: |
12 |
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Ongoing Trials: |
38 |
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Total of Trials To Date: |
70 (approx. 1/3 multi-site studies) |
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Trials Under Negotiation: |
22 |
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Sponsors To Date: |
33 (Pharma and CRO's) |
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Sponsor Audits: |
13 |
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FDA Audits: |
0 |
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Investigators in Database: |
137 (approx. 37 active) |
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Patient Database: |
9,680 Patients (May, 2000 – Sept., 2003) |
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Hospital Affiliations: |
5 |
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University Affiliations: |
3 |
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Publications |
3 |
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Academic Events:
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3 Internationally (Sept., 2003) |
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-DIA's 2nd Latin American Congress of Clinical Research |
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-National Cancer Institute, Mexico / National Cancer
Institute, Canada |
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-DIA's 1st Latin American Congress of Clinical Research |
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Speaker Engagements: |
12 National & International Clinical Research Congresses |
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