Cliantha Corp PPT

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

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© 2012 Cliantha Research Limited 4

Submissions and Sponsors

Accreditations & Inspections


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:


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:


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


Regulatory Inspections History – Mexico


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


Expertise in:

Global feasibility studies

Project management

Site management and risk based monitoring

Regulatory affairs

Supply management

Central lab services

BA/BE Studies


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


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


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


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


Quality Assurance (QA)QA team independently monitors all activities ensuring compliance to Protocol, SOPs, GCP, GLP and other regulations:


Project flow


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)


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


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


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

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Dr. Shaifali GuptaHead, Central Reference lab11 years Pathology experience

Hitesh ChauhanAssociate Director, Biometrics 12 years of Statistics & CDM experience

Our Assets


Cliantha team700 and growing…including 20 doctors

Combined experience of over 50 years at leading pharma cos and CROs

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Thank You

www.cliantha.in


Documents

Cliantha Corp PPT