Fortis Clinical Research Ltd.,Fortis Clinical Research Ltd.,(FCRL)(FCRL)

Be a leading provider of quality clinical research services from India

to facilitate the drug development efforts of the global pharmaceutical industry.

VisionVision

FCRL ProfileFCRL Profile

Established: April 2005

Location: Sunflag Hospital, Faridabad (HR)

Space: 19,000 sq ft.

Infrastructure: Clinical wards, pharmacy, bioanalytical

labs, archives, IT, QA

Operational: 29th Sept 2005

ServicesServicesBioavailability /

Bioequivalence Studies

Phase I Studies

Clinical Data Management

Biostatistics and Programming

Medical Writing

Clinical Laboratory

Bioanalytical Laboratory

Phase II-IV Studies

Pharmacovigilance

Corporate OrganogramCorporate Organogram

BoardOf Directors

Chief Executive

Clinical Operations

Bioanalytical Operations

Quality Assurance

&Training

Clinical TrialsBusiness

Development

Finance, Purchase,

HR,Admin &

Information Tech.

MD (Microbiology): JN Medical College, AMU, AligarhTeaching experience: All India Institute of Medical Sciences,

New Delhi, 12 yearsTraining: 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 ExecutiveDr Ashok Rattan

Name Dr Deepak Chilkoti Ms Shireen Rao Mr KK Singh Ms Meenakshi Bakshi

Designation Head: Clinical Head: Bioanalytical Head: IT Head: QA and training

Academic background

MBBS, MD M.Pharm MBA information MSc (Biochem)

Experience ~ 4 yrs  ~ 13 yrs ~ 16 yrs ~ 13 yrs

In FCRL Since Jul ’08 (2nd stint)

Since Jan ’05 Since Oct ’08 Since Oct ’04

Key Personnel

The Work ForceDepartment Existing Positions

Clinical 28

BioAnalytical 33

Quality Assurance 8

Business Development 3

Clinical Trials 6

IT & Instrumentation 4

General Administration 10

   

Total 92

The Current FacilityThe Current Facility

Designed for conducting BA/BE studies in healthy human volunteers:

Clinical Pharmacology Unit (8500 sq ft)

Bioanalytical Laboratory (4500 sq ft)

Support Services (6000 sq ft)

Clinical Pharmacology UnitClinical Pharmacology UnitInfrastructure

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

Biometrics VDMSBiometrics VDMS

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 LaboratoryBioanalytical Laboratory

Bioanalytical LaboratoryBioanalytical Laboratory More than 115 validated methods including methods for premium molecules

More methods in development and validation stage

All processes 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

Pharmacokinetics & StatisticsPharmacokinetics & Statistics• Statistical design and analysis of protocol for:

Pre-clinical

Bioequivalence and

Phase I, II, III studies

Sample size estimation

• Randomisation - Block, Stratified, Blinded

• Statistical Analysis Plan (SAP)

• Supportive analysis - Interim, Post-hoc and Exploratory analysis

Medical WritingMedical Writing

Protocols / Investigator's brochure

Integrated Clinical Study Reports

Clinical / non-clinical sections of common technical document (CTD)

Abstracts, manuscripts and poster presentations

Quality AssuranceQuality 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

Audits / ApprovalsAudits / Approvals

DCGI (India)Approval to conduct BA BE Studies with new drugs granted on 13th 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.

Study Description

– Type: Single dose, Multi-dose, Steady-state, Dose escalation– Design: Pilots, 2-way, 3-way and Replicate Pivotals

Formulations I nvestigated

– Tablets: Immediate release, Sustained release, Extended release, Modified release

– Dispersible Tablets: Mouth dispersible tablets, Dispersible tablets for suspension

– Capsules: Capsule as a whole dose and after dispersing in apple sauce

– Suspensions: Pre-constituted and re-constituted

Bioavailability / Bioequivalence Studies

138

95

0

20

40

60

80

100

120

140

Bioavailability / Bioequivalence Studies

More than 230 studies conducted

South Africa2

Australia10

EU37

USFDA4

Brazil17

Canada3

Others22

Bioavailability / Bioequivalence StudiesMore than 90 pivotal studies conducted

Successfully conducted Phase-I study on H1N1

Australia Brazil Bulgaria Canada Denmark Eastern Europe Finland France Germany Hungary India

I taly I reland Netherland Norway Poland Portugal Romania South Africa Spain USA UK

Report SubmissionReport Submission

Hospital NetworkFortis Escorts (28) Wockhardt (10)

Laboratory Network (57 Labs, 1200 Collection centres)Laboratory Network (57 Labs, 1200 Collection centres)Excellent Pan India Logistics to move IP and samples from and to clinical sitesExcellent Pan India Logistics to move IP and samples from and to clinical sites

Pan India Presence

Chairpersons of Therapeutic Advisory BoardClinical Trials

Therapeutic areaChairperson 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

Fortis / Escorts Hospitals Network (28)Fortis / Escorts Hospitals Network (28)

Fortis / Wockhardt Hospitals Network (10)Fortis / Wockhardt Hospitals Network (10)

Thank You…!Thank You…!