www.cliantha.in
A leading global Life Science Company
History
© 2012 Cliantha Research Limited2
Founded BA Research India Limited, now renamed as Cliantha Research Limited
Inaugurated with 122 beds and 4 LC/MS/MS, Central Reference Lab accredited by CAP20042004
Inaugurated a new facility at Vadodara city (2 hour drive from Ahmedabad) with 200 beds and CAP accredited Path Lab
Bioanalytical lab upgraded to 13 LC/MS/MS
Introduced Transdermal clinical studies
20072007
Introduced a new facility in Ahmedabad with capacity of 100 beds
Introduced Clinical Data Management Services
Bioanalytical lab upgraded to 16 LC/MS/MS 20092009
Introduced patient based Clinical Trials (Phase II‐IV)
Bioanalytical lab upgraded to 18 LC/MS/MS 20102010
Cliantha Research acquired Hill Top Research; a leading CRO in USA and Canada specialized in Dermatology Rx and Personal Healthcare. For details log on: www.hill‐top.com
Established BA/BE services in Mexico City
ICP‐OES was added to Bioanalytical lab
20112011
The expertise, methodology and experience of our Clinical Trials team inspired us to launch a focused website: www.clianthatrials.com 20122012
© 2012 Cliantha Research Limited
CANADAWinnipeg
INDIAMexico CitySt. Petersburg Ahmedabad
Vadodara
3
© 2012 Cliantha Research Limited 4
Submissions and Sponsors
Accreditations & Inspections
© 2012 Cliantha Research Limited 5
Government Of IndiaFacilities inspected & approved by Drugs Controller General of India
Inspected facility in Nov 2006
Recent inspection in June 2012
Inspected and certified Cliantha facility in Mexico City in April 2012
Inspected facility in April 2011 Inspected facility in Jan 2009
Locations registered in September, 2012
Recent inspection in Oct 2011
Inspection of Diagnostic lab in Aug 2011
Inspected in Feb 2011
Recent inspection of Diagnostic Lab in July, 2012
Cliantha Research has been successfully inspected by following regulatory agencies:
© 2012 Cliantha Research Limited6
Regulatory Inspections History ‐ India
Date InspectionNov 06‐11, 2006 Ahmedabad HQ by ANSM (GCP & GLP)
May 14‐17, 2007 Ahmedabad HQ by USFDA (GCP)
Sep 20‐21, 2007 Ahmedabad HQ by USFDA (GCP, GLP & Stats)
Sep 15‐19, 2008 Vadodara by USFDA (GCP)
Jan 12‐13, 2009 Ahmedabad HQ by MCC (GCP, GLP & Stats)
Jun 17‐23, 2010 Ahmedabad HQ by USFDA (GLP & Stats)
Oct 18‐20, 2010 Ahmedabad HQ by WHO (GCP, GLP & Stats)
Oct 18‐22, 2010 Ahmedabad Sigma by USFDA (GCP)
Oct 25‐27, 2010 Ahmedabad HQ by USFDA (GCP)
Feb 9‐10, 2011 Vadodara by AGES (GCP)
April 11‐12, 2011 Vadodara by AEMPS (GCP)
April 13‐15, 2011 Ahmedabad HQ by AEMPS (GLP & Stats)
Oct 3‐7, 2011 Vadodara by USFDA (GCP)
Jun 19‐22, 2012 Ahmedabad HQ and Sigma by WHO (GCP, GLP & Stats)
All the three locations of Cliantha Research Limited are inspected & approved by Drug Controller General of India (DCGI)
Diagnostic Lab:
© 2012 Cliantha Research Limited7
Regulatory Inspections History ‐ India
Date InspectionSep, 2007 Cliantha HQ by CAP
Sep, 2008 Cliantha Vadodara by CAP
Sep, 2009 Cliantha Sigma by CAP
Sep, 2010 Cliantha Vadodara by CAP
Aug, 2011 Cliantha Sigma by CAP
Aug, 2011 Cliantha Vadodara by CAP
July , 2012 Cliantha Sigma by ANVISA
Cliantha facility in Mexico City has been inspected and certified by Cofepris in April 2012 and is now fully operational
© 2012 Cliantha Research Limited 8
Regulatory Inspections History – Mexico
© 2012 Cliantha Research Limited9
Our Services
Cliantha Trials BA/BE Studies Dermatology
Personal Healthcare Biometrics
Central Reference Lab
Cliantha Trials
Infrastructure setup to conduct global Phase I‐IV trials
1500+ GCP trained validated quality investigator sites in USA, EU and India
Therapeutic areas: Oncology/Hematology, Dermatology, Psychiatry, Cardiology, Diabetology, Ophthalmology and Gastroenterology
Combined team experience of more than 50 years in clinical trials
For more details log on to: www.clianthatrials.com
© 2012 Cliantha Research Limited10
Expertise in:
Global feasibility studies
Project management
Site management and risk based monitoring
Regulatory affairs
Supply management
Central lab services
BA/BE Studies
© 2012 Cliantha Research Limited11
Conducted over 1500 studies
9 clinical units, 400 beds, 12 ICU beds and 20 doctors
Central Lab accredited by CAP
55,000 healthy subjects database
Infrastructure includes freezers, cardiac monitors, secured pharmacy, controlled archives, and power backup
Bioanalytical
Labs in India and Mexico City
Over 180 analytical methods in biological fluids
21 LC/MS/MS (API 3000,4000, 5500)
ICP‐OES for elemental analysis
Over 1.5 million samples analyzed
©2012 Cliantha Research Limited12
Dermatology
Cliantha Research acquired Hill Top Research, which specializes in managing Phase I‐IV clinical trials with focus on Dermatology
Opportunity to execute studies in multiple locations with multiple climatic conditions in N. America and/or India
Established Global Interscorer variability
© 2012 Cliantha Research Limited13
Transdermal/Topical Bioequivalence
Contact Sensitization‐Human Repeat Insult Patch Test (HRIPT)
Cumulative Irritation (14 and 21 day studies)
Wear studies
Skin Blanching (Vasoconstriction studies)
Expertise in:
Personal Healthcare
Hill Top Research, with over 65 years experience in Personal Healthcare industry
Two locations with different climatic conditions and patient pool
Safety studies for OTC, cosmetic and personal healthcare products
© 2012 Cliantha Research Limited14
Expertise in:Phototoxicity
Photoallergy
Comedogencity
Skin care – anti‐aging, moisturizers, skin of color
Antiperspirants and deodorants
Personal Hygiene products
Baby care products
Feminine care products
Cosmetic products
Biometrics
Full service ‐ CDM, Pharmacokinetics and Statistics
Infrastructure based in India
eCRF and paper CRF – SAS PheedIT
Libraries ‐MedDRA, WHODD
WinNonlin® ‐ Pharmacokinetic analysis
SAS® ‐ Statistical analysis
Reports ‐ FDA, ICH E3, TPD, TGA formats
© 2012 Cliantha Research Limited15
Central Reference Lab
CAP accredited lab with state‐of‐the‐art facilities for multi‐centric Clinical Trials
Complete range of specialized tests with a test menu covering Hematology, Coagulation, Clinical chemistry, Immunology, Serology, Clinical Pathology, Flow Cytometry
Combines innovative R&D capabilities for developing and validating ligand binding assays for macromolecules for PK and immunogenicity studies
Capabilities to develop and validate an Assay to meet specific needs of a protocol
© 2012 Cliantha Research Limited 16
Quality Assurance (QA)QA team independently monitors all activities ensuring compliance to Protocol, SOPs, GCP, GLP and other regulations:
© 2012 Cliantha Research Limited 17
Project flow
© 2012 Cliantha Research Limited 18
Set-up weekly calls for regular study updatesSet-up weekly calls for regular study updates
Typical Timeline chart (Assumptions: No. of subject: 36, No. of periods: 2,Washout period: 7 days; Delivery in < 120 days)
Day 0 ‐7 8‐14 15‐21 22‐28 29‐35 36‐42 43‐49 50‐56 57‐63
Week W1 W2 W3 W4 W5 W6 W7 W8 W9
Project Confirmation
Protocol finalization
EC & BE NOC/T‐License
MD/MV (if applicable)
© 2012 Cliantha Research Limited19
Day 64-70 71-77 78-84 85-91 92-98 99-105 106 -113 114-120
Week W 10 W 11 W 12 W 13 W 14 W 15 W 16 W 17
IP Transfer
Clinical Phase completion
Bioanalysis
PK/Statistics
Draft report
Final report
Case study
Flawless fastest ANDA
First to File submission:
• Completed USFDA bio submission
study within a week
• Meticulous coordination between
the respective teams enabled to
accomplish perfect study and deliver
the data without compromising any
ethical standards
© 2012 Cliantha Research Limited 20
Milestones Fasting BE Study (n=36)
Fed BE study (n=36)
Clinic starts 04‐Apr‐2012 05‐Apr‐2012
Clinic ends 08‐Apr‐2012 09‐Apr‐2012
Bioanalysis starts
08‐Apr‐2012 09‐Apr‐2012
Bioanalysis ends
10‐Apr‐2012 10‐Apr‐2012
Final report 10‐Apr‐2012 10‐Apr‐2012
Team
© 2012 Cliantha Research Limited
Vijay PatelExecutive Director 21 years Management experience
Naveen SharmaChief Operating Officer17 years Research experience
Dr. Robert A. HarperPresident25 years Dermatology experience
Dr. Charu GautamDirector, Global Clinical Operations13 years Clinical experience
Anita KaulVice President, Global Quality Assurance 20 years QA experience
Rahul NijhawanAssociate Director, Global Project Management12 years Research experience
Arpana PrasadAssociate Director, Bioanalytical lab 15 years Bioanalytical experience
Anshul DograAssociate Director, Bioanalytical lab 12 years Bioanalytical experience
Dr. Simran SethiGeneral Manager, Medical Affairs13 years of Research experience
21
Dr. Shaifali GuptaHead, Central Reference lab11 years Pathology experience
Hitesh ChauhanAssociate Director, Biometrics 12 years of Statistics & CDM experience
Our Assets
© 2012 Cliantha Research Limited
Cliantha team700 and growing…including 20 doctors
Combined experience of over 50 years at leading pharma cos and CROs
22
Thank You
www.cliantha.in
© 2012 Cliantha Research Limited23
Top Related