Clinical Section
FCRL provides
comprehensive trial management of early-phase clinical trials.
Facility is designed specifically for conducting bioavailability
and bioequivalence studies. The clinic has wide range of specialized
instruments for management of adverse events, store investigational
products, handle biological samples.
Qualified and experienced professionals manage
projects assigned to the clinic. Team consisting of Clinical Investigators, Study
Coordinators, Research Officers, Volunteer Development Group etc., work closely
with their clients to assure all protocol requirements are met.
To
ensure menu consistency among volunteers in each study, a registered
caterer manages the onsite food service and a qualified dietician
is available to prepare specialized diet menus for protocols that
require them.
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The details of the infrastructure of the clinical section are as follows: |
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78-bed wards with security access |
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Counselling and screening area |
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2-Bed ICU (equipped with defibrillator, pulse oximeter, nebuliser, ECG machine, suction machine, ambu bag) |
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Drug store with temperature/humidity chamber |
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16 phlebotomy stations |
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Sample separation and storage lab with deep freezers (-80ºC & -20°C), refrigerators and centrifuges |
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Recreation area |
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Dining area |
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Kitchen / Pantry |
FCRL volunteer bank has
over 2500
healthy human volunteers in its database and increasing constantly. A recruitment cell contacts healthy adult volunteers in the 18-45 yrs age group from Faridabad and adjoining areas. The recruitment process includes person-to-person contact and contact through student's organizations, and distribution of IEC approved handouts / pamphlets addressing potential questions of the volunteers. All the volunteers are screened for the suitability by history of their present and past illnesses, physical examination, laboratory tests, ECG, X-ray and protocol specific investigations, if any.
FCRL has access to three independent ethics committees in NCR region which are structured as per ICH guidelines and serve to facilitate the speedy review and approval of protocols, ICFs and review of clinical logistics at the facility.
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