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					                    Fortis Clinical Research Limited


Fortis Clinical Research Ltd. (FCRL) is a professional CRO established in 2005. It is a
state-of-the-art facility based in the multi-speciality Sunflag Hospital & Research Centre in
Faridabad near Delhi in Northern India. FCRL is headed by Dr Ashok Rattan who has over
30 years of international R&D experience in AIIMS, Ranbaxy New Drug Discovery, PAHO /
WHO and SRL. FCRL is staffed by a team of over 100 professionals committed to delivery
of quality services in a timely manner.
SERVICES


        Bioequivalence Services                          Clinical Trial Services

     Studies in healthy volunteers and             Project Management
     post-menopausal women                         Study Monitoring
     Studies in cancer and psychiatric             Medical Writing
     patients                                      Medical Monitoring
     Method development and validation             Safety Surveillance
     and clinical sample analysis
                                                   Site Management
     A biometric, web-based Volunteer
                                                   Data management using a 21 CFR
     Data Management System (VDMS)
                                                   part 11 compliant software in
     in liaison with regional CROs
                                                   collaboration with a trusted partner



          SUBMISSIONS

         Reports generated from FCRL have been submitted to:


         • Australia          • Eastern Europe • India                 • Romania
         • Brazil             • Finland           • Italy              • South Africa
         • Bulgaria           • France            • Ireland            • Spain
         • Canada             • Germany           • Netherlands        • USA


         AUDITS AND APPROVALS

          AFSSAPS (France), ANVISA (Brazil), DCGI (India).
          UK-MHRA and other audits expected during 2009-2010


          LIST OF BIOANALYTICAL VALIDATED METHODS

          More than 100 bioanalytical validated methods (List available on request)
 QUALITY ASSURANCE

• SOP-driven systems with periodic reviews
• Induction and regular training of staff
• Periodic internal audits of facility, systems and processes
• Study-specific audits during initiation, in-process and reporting phases


  INFRASTRUCTURE



                Clinical                                   Bioanalytical

   • 78-bed ward with 2-bed ICU                  • Sample processing labs with
                                                    provision to handle light-sensitive
   • A separate counseling and                      drugs
      screening area                             • 7 LC/MS/MS machines (Sciex API
   • Drug store with temperature &                  3000 & 4000);
      humidity chamber                           • Analyst (version 1.4.1) with disaster
                                                    management system in place
   • 18 phlebotomy stations
                                                 • WinNonlin (version 5.0.1) and SAS
   • Separate recreational, dining and              (version 9.1.3).
      pantry areas                               • A -20ºC walk-in cold room and
                                                    -80ºC deep freezers



  Ethics Committees
  FCRL has access to two independent ethics committees which function as per national
  and ICH-GCP guidelines.

  Volunteer Databank
  Over 5000 healthy volunteers in the databank including post-menopausal females.



   CONTACT INFORMATION

    Fortis Clinical Research Limited
    Sunflag Hospital & Research Centre
    Sector 16-A
    Faridabad, Haryana 121 002 (INDIA)
    Ph: +91-129-4090 900
    Fax: +91-129-4090 924
    www.fortis-cro.com
    ashok.rattan@fortis-cro.com
    suman.sharma@fortis-cro.com

				
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posted:4/4/2011
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