Services Bioavailability / Bioequivalence Studies Phase I Studies Clinical Data Management Biostatistics and Programming Medical Writing Clinical Laboratory Bioanalytical Laboratory Phase II-IV Studies Pharmacovigilance
Corporate Organogram Board Of Directors Chief Executive Clinical Operations Bioanalytical Operations Quality Assurance & Training Clinical Trials Business Development Finance, Purchase, HR, Admin & Information Tech.
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
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
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
Handling sponsor audits for assessment of FCRL’s facilities &
GCP / GLP compliance
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.
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
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