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  • 1. Fortis Clinical Research Ltd., (FCRL)
  • 2. Be a leading provider of quality clinical research services from India to facilitate the drug development efforts of the global pharmaceutical industry. Vision
  • 3.  
  • 4. Services Bioavailability / Bioequivalence Studies Phase I Studies Clinical Data Management Biostatistics and Programming Medical Writing Clinical Laboratory Bioanalytical Laboratory Phase II-IV Studies Pharmacovigilance
  • 5. Corporate Organogram Board Of Directors Chief Executive Clinical Operations Bioanalytical Operations Quality Assurance & Training Clinical Trials Business Development Finance, Purchase, HR, Admin & Information Tech.
  • 6. MD (Microbiology): JN Medical College, AMU, Aligarh Teaching experience: All India Institute of Medical Sciences, New Delhi, 12 years Training: Dundee Institute of Technology, Scotland, CDC Atlanta and NIH, USA MHH, Hanover, Germany Drug Discovery: Director, Infectious Diseases, Ranbaxy Work Experience: Clinical Microbiologist and administrator Experienced in PK/PD of antibiotics, Running of Quality systems in Drug Discovery, Diagnostic Laboratory for World Health Organization in the Caribbean, CAP and NABL accredited Lab in India Ph D students guided or co guided: 40 Research Papers published : >100 International Patents : 10 Profile of Chief Executive Dr Ashok Rattan
  • 7. Key Personnel Since Oct ’04 Since Oct ’08 Since Jan ’05 Since Jul ’08 (2nd stint) In FCRL ~ 13 yrs ~ 16 yrs   ~ 13 yrs ~ 4 yrs Experience MSc (Biochem) MBA information M.Pharm MBBS, MD Academic background Head: QA and training Head: IT Head: Bioanalytical Head: Clinical Designation Ms Meenakshi Bakshi Mr KK Singh Ms Shireen Rao Dr Deepak Chilkoti Name
  • 8. The Work Force 92 Total     10 General Administration 4 IT & Instrumentation 6 Clinical Trials 3 Business Development 8 Quality Assurance 33 BioAnalytical 28 Clinical Existing Positions Department
  • 9.  
  • 10. Clinical Pharmacology Unit
    • Infrastructure
    • Volunteer screening area
    • 78-beds
    • 2-bed ICU
    • Pharmacy
    • Phlebotomy and nursing stations
    • Synchronized electronic clocks
    • Dining and recreation area
    • Sample separation room
    • Biometric VDMS
  • 11. Biometrics VDMS
  • 12.
    • Infrastructure
      • Sample Processing Lab 1
      • Sample Processing Lab 2
      • (for light-sensitive molecules)
      • Walk-in cold room
      • UPS Room
      • Instrumentation
      • LC/MS/MS 7
      • Deep Freezers 5
      • Cold Room 1
      • Centrifuges 7
    Bioanalytical Laboratory
  • 13. Bioanalytical Laboratory
      • More than 115 validated methods including methods for premium
      • molecules
      • More methods in development and validation stage
      • All process es are as per GCP/ GLP
      • Method Validation is in compliance with USFDA guidance
      • Routine performance of Incurred Sample Reproducibility
      • Determination of two or more analyte in a single run
      • Sensitivity level achieved as low as 25 pg/ml
  • 14. Pharmacokinetics & Statistics
    • Statistical design and analysis of protocol for:
      • Pre-clinical
      • Bioequivalence and
      • Phase I, II, III studies
      • Sample size estimation
    • Randomisation - B lock, S tratified, B linded
    • Statistical Analysis Plan (SAP)
    • Supportive analysis - Interim, Post-hoc and Exploratory analysis
  • 15. Medical Writing
      • Protocols / I nvestigator's brochure
      • Integrated Clinical Study R eports
      • Clinical / non-clinical sections of common technical document
      • (CTD)
      • Abstracts, manuscripts and poster presentations
  • 16. Quality Assurance
      • GCP / GLP audits (In-process, Retrospective & System Audits)
      • Vendor audits (Pathology Labs, X-ray units, Caterers etc.)
      • Handling regulatory inspections (National & International)
      • Handling sponsor audits for assessment of FCRL’s facilities &
      • GCP / GLP compliance
  • 17. Audits / Approvals DCGI (India) Approval to conduct BA BE Studies with new drugs granted on 13 th January 2006. AFSSAPS (France): Approved - based on Feb ’08 audit. ANVISA (Brazil) Approved as a GCP-compliant site for clinical, bio-analytical and statistical support for BA/BE studies based on audits in March 2006, August 2007 and in August 2009.
  • 18.  
  • 19. Bioavailability / Bioequivalence Studies M ore th a n 230 s tudies conducted
  • 20. Bioavailability / Bioequivalence Studies M ore th a n 90 pivotal s tudies conducted Successfully conducted Phase-I study on H1N1
  • 21.  
  • 22. Hospital Network Fortis Escorts (28) Wockhardt (10) Laboratory Network (57 Labs, 1200 Collection centres) Excellent Pan India Logistics to move IP and samples from and to clinical sites Pan India Presence
  • 23. Chairpersons of Therapeutic Advisory Board Clinical Trials Therapeutic area Chairperson Attachment Cardiology Prof U Kaul Escorts Critical care Dr A Varma Escorts Gynae Prof S Mittal, AIIMS Dermatology Prof N Khanna, AIIMS ID Prof TD Chugh BL Kapoor Rheumatology Prof A Kumar FHVK Oncology Prof V Raina, AIIMS Gastroenetrology Dr A Choradiya FHN PBL Prof K Varma SGRH Patient safety Prof U Gupta FHN Device Related Prof H Singh, IIT
  • 24. Fortis / Escorts Hospitals Network (28)
  • 25. Fortis / Wockhardt Hospitals Network (10)
  • 26. Thank You…!