Clinical
Pharmacology and Pharmacokinetic Services
Our staff
comprises highly qualified and experienced
professionals who manage all aspects of
Phase I and Bioequivalence/Bio-availability
studies including: Project management,
Study conduct and monitoring, Volunteer
screening, Medical writing, Bio-analytical
evaluation, Data Management & Statistics,
Quality Assurance, Regulatory Affairs,
Pharmacy services |
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Volunteer enrollment
Access to a database of more than 3, 550 healthy volunteers
Subjects for a variety
of pharmacokinetic and pharmacodynamic studies
Capable of creating special
volunteer groups for study specific needs like
Hypertensive volunteers, renal failure volunteers
etc
The main clinical facility is located
at the Dhirubhai Ambani Life Sciences Centre of
Reliance Life Sciences, Navi Mumbai. It is equipped
with:
State-of-the-art facility for conducting Phase I and
Bioequivalence/Bioavailability (BA/BE) studies for up to 40
concurrent subjects.
Facility for housing
female volunteers
State-of-the-art
10 bed ICU facility for Phase-I studies with Telemetry and web
enabled monitoring.
Secure access control system
Bar-coding for volunteers
and each biological sample
Fully equipped ICU for
emergency handling
Direct capture of laboratory
results
24 hour ambulance facility
and link with GPS Cardiac ambulance.
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In addition, RCRS also has a 70 Bed clinical
facility at Bangalore for conducting Bioequivalence/
Bioavailability (BA/BE) studies
The services offered are compliant with regulatory
requirements of US FDA, ANVISA (Brazil), MHRA
(UK), MCA (South Africa), TGA (Australia) and
DCGI (India).
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