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Translations
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IMIC provides
certified translation services of regulatory documents, study
protocols, patient–oriented materials, and Informed Consent forms.
Feasibility Studies
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IMIC
has the capability to conduct feasibility studies to predetermine
the proper study population in any therapeutic area. Therefore, IMIC
has established a working relationship with governmental medical
institutions to have access to their database and assess the
possibility of placing trials in Mexico City or other areas of the
country.
Patient Recruitment
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IMIC patient
recruitment is a well-integrated system that has been implemented to
support the patient enrollment of all IMIC studies. The system has a
contact service area that tracks all calls and screened patients,
and continuously feeds information to the patient database that
supports recruitment for future or ongoing trials. This department
is in charge of developing advertising and follow-up strategies and
materials.
Regulatory Support
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IMIC
provides support to sponsors in preparing all documents for the
regulatory submission to the IRB's
and the Ministry of Health agency in Mexico. This process is
delegated to a specialist that deals entirely with the regulatory
agency personnel.
In addition, IMIC prepares the importation of study drugs and works
jointly with Mexican customs to guarantee drug availability on the
initiation of all trials. We estimate that it could take
approximately 60 days before the trial is initiated; from the time
all study documents are received, reviewed, translated, submitted to
the IRB and MoH, until the drug shipment arrives to our pharmacy.
IMIC - Flow Chart
of Regulatory Approval Process
Development of Trials
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Clinical trials
can be conducted entirely in our facility, or in hospital
environments according to the study protocols, by the study team
that consists of a Principal Investigator, Sub-investigators, and
study coordinators. All IMIC team members are full time and trained
under IMIC policies and procedures, ICH and GCP guidelines, and
Mexican and FDA regulations. All trial procedures are subject to QA
controls, establishing uniform high-standard operation.
Therapeutic Areas
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Cardiology / Vascular Diseases
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Dental / Maxillofacial Surgery
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Dermatology
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Endocrinology including Diabetes & Obesity
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Gastroenterology including Liver Disease
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Hematology
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Immunology
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Infectious Diseases
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Musculoskeletal
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Nephrology / Urology
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Neurology / Central Nervous System
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Obstetrics / Gynecology
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Oncology
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Ophthalmology
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Otolaryngology
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Pediatrics / Neonatology
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Pharmacology / Toxicology
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Psychiatry / Anxiety and Depression
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Pulmonary / Respiratory Diseases
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Rheumatology
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Trauma
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Women's Health
IMIC - Experience
Summary
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The following link
will take you to a
list of IMIC's study
experiences by
therapeutic areas,
indication, phase of
study, number of
patients and our
involvement.
IMIC - Study
Experience Summary |