Clinical Research Services

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 clinical trials services, drug trials, drug development
 BA/BE
 Phase I
 Phase II A
 Oncology
clinical research, clinical research services, clinical studies

BA/BE

    Bioequivalence/ Bioavailability studies

FCRL has conducted more than 100 Bioequivalence studies for generic pharmaceutical products. The BE study reports have been submitted by the sponsors to Brazil, UK, and to most of the EU countries (Finland, France Spain, Denmark, Norway, Ireland, Italy, Poland, Portugal, Germany, Hungary, Ireland, Netherlands etc), South Africa, Malaysia, India and Canada.  FCRL has been approved by AFSAAPS (France), twice by ANVISA (Brazil) and DCGI (India).


    Infrastructure
clinical research

Hospital-based Clinical Pharmacology Unit

clinical research

Access to Intensive Care Unit of Hospital

clinical research

Access-controlled Pharmacy, Archives and Server room

clinical research

Dedicated sample processing laboratories

clinical research

LCMS-based bioanalytics

clinical research

Statistical analysis using SAS

clinical research

Pharmacokinetic analysis using WinNonlin

clinical research

Access to Independent Ethics Committees

clinical research

Database of  healthy male, female and post-menopausal female volunteers


    Team
clinical research

Medical Writers

clinical research

Clinical Research Physicians with extensive experience in BE studies

clinical research

Pharmacokineticists

clinical research

Biostatisticians

clinical research

Quality Assurance

clinical research

IT


   
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