Full Service CRO

Cliantha is an independent global Contract Research Organization (CRO) providing integrated

clinical offerings in Early Phase (Phase I/IIa), Late Phase (Phase II-IV), Bioequivalence (BA/BE),

Clinical Endpoint Trials, Bioanalytical, Biosimilars, Dermatology, Respiratory, Allergy, Biometrics,

Pharmacovigilance and Personal Healthcare services. Our services have science at its foundation

that is developed through regular and systematic training of the Cliantha Team.

Cliantha offers Biosimilar, Biotech, Cosmetic, Generic, Personal Healthcare and Pharmaceutical

companies a comprehensive range of clinical research and support services. You will notice we

use our legacy brand names: Cliantha Research, Hill Top Research, Inflamax Research and

Karmic Lifesciences, however, we operate as one company – Cliantha. We have added and

enhanced the capabilities during the past 6 years in each of the companies to provide our

sponsors with a single, global research network.

About Us

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Cliantha locations

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EUROPE, SOUTH AMERICA AND SOUTH AFRICA THROUGH PARTNERS

CANADA

INDIA

St. Petersburg Ahmedabad Vadodara

Toronto

Winnipeg

Mumbai

New Delhi New Jersey

Cliantha locations

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Ahmedabad Clinic (196 Beds)

Bioanalytical Lab Clinical Lab Clinical Trials Personal Healthcare Pharmacovigilance Clinical Data Management

Vadodara Clinic (200 Beds)

Clinical Lab

Noida (Delhi) Clinic (117 Beds)

Clinical Lab

Mumbai Clinical Trials

Clinical Data Management

Hill Top Research New Jersey Clinic (100 Beds)

Hill Top Research

St. Petersburg Clinic (48 Beds)

Personal Healthcare

Cliantha Research Toronto Bioanalytical Lab

IVRT Lab

Inflamax Research Toronto Clinic (100 Beds)

Environmental Exposure Chambers

Hill Top Research Winnepeg Personal Healthcare

USA Canada India

Submissions

• > 90% for US (FDA) and the EU (EMA)

• Canada

• India

• Japan

• South Africa

• Russia

• Australia

• WHO

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GLOBALLY DIVERSE

Global Clients and Submissions

Experience with Route of administration

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Injection

Oral

•Tablet (IR, ER, DR, OD, EC)

•Capsule (Soft Gel, MR)

•Chewable Tablets

•Suspension

•Granules

•Sublingual

Rectal

Transdermal

Vaginal

Pulmonary

Accreditations & Inspections

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Accreditations & Inspections

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Government of India Facilities inspected & approved by Drugs Controller General of India

Inspected facility in Nov 2006 by ANSM

Last inspection in March 2013 by WHO (3 times)

Inspected facility in April 2011 by Spain Inspected facility in Jan 2009 by MCC

Last Inspection in Nov 2015 by Austria (2 times)

Last inspection in April 2017 by UK MHRA (2 times)

Inspected facility in July 2013 by Thai MOH

Facilities inspected & approved by Ministry of Health of Turkey in April 2013

Last inspection in March 2018 by USFDA (18 times)

Regulatory Inspections History – India

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All the four locations of Cliantha Research Limited – Ahmedabad HQ, Ahmedabad Sigma, Vadodara & Noida are approved by Drug Controller General of India (DCGI)

Date Inspection details

March 05 – 09, 2018 Noida (Clinical)

March 20 – 23, 2017 Ahmedabad HQ (Clinical)

March 14 – 17, 2017 Ahmedabad Sigma (Clinical)

Nov 28 – Dec 2, 2016 Vadodara (Clinical)

April 25 – May 3, 2016 Ahmedabad HQ (Bio-Analytical)

Jan 18 – 22, 2016 Ahmedabad HQ (Clinical)

Mar 23 – Apr 03, 2015 Ahmedabad Sigma(Clinical)

Aug 18 – 22, 2014 Vadodara (Clinical)

May 19 – 23, 2014 Ahmedabad HQ (Clinical & Bio-Analytical)

Jan 20 – 24, 2014 Ahmedabad HQ (Clinical)

June 24 – 28, 2013 Vadodara (Clinical)

Oct 03 – 07, 2011 Vadodara (Clinical)

Oct 25 – 27, 2010 Ahmedabad HQ (Clinical)

Oct 18 – 22, 2010 Ahmedabad Sigma (Clinical)

June 17 – 23, 2010 Ahmedabad HQ (Bio-Analytical & Stats)

Sept 15 – 19, 2008 Vadodara (Clinical)

Sept 20 – 21, 2007 Ahmedabad HQ (Clinical, Bio-Analytical & Stats)

May 14 – 17, 2007 Ahmedabad HQ (Clinical)

USFDA Inspections

Regulatory Inspections History – India

Date Inspection details

April 24 – 28, 2017 Ahmedabad HQ and Sigma by UK MHRA (Clinical & Bio-Analytical )

Nov 03 – 05, 2015 Vadodara by AGES (Clinical)

July 15 – 18, 2013 Ahmedabad HQ Thailand MoPH (GLP)

April 09 – 11, 2013 Ahmedabad HQ and Sigma MoH Turkey (GLP & GCP)

Mar 19 – 22, 2013 Ahmedabad HQ and Vadodara by WHO (Clinical, Bio-Analytical & Stats)

Feb 25 – Mar 01, 2013 Ahmedabad HQ and Sigma by UK MHRA (Clinical, Bio-Analytical & Stats)

June 19 – 22, 2012 Ahmedabad HQ and Sigma by WHO (Clinical, Bio-Analytical & Stats)

April 13 – 15, 2011 Ahmedabad HQ by AEMPS (Bio-Analytical & Stats)

April 11 – 12, 2011 Vadodara by AEMPS (Clinical)

Feb 09 – 10, 2011 Vadodara by AGES (Clinical)

Oct 18 – 20, 2010 Ahmedabad HQ by WHO (Clinical, Bio-Analytical & Stats)

Jan 12 – 13, 2009 Ahmedabad HQ by MCC (Clinical, Bio-Analytical & Stats)

Nov 06 – 11, 2006 Ahmedabad HQ by ANSM (Clinical & Bio-Analytical)

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Other Inspections

All the four locations of Cliantha Research Limited – Ahmedabad HQ, Ahmedabad Sigma, Vadodara & Noida are approved by Drug Controller General of India (DCGI)

Regulatory Inspections History – India

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Date Inspection details

Jan, 2018 Noida by CAP

Oct, 2017 Sigma by NABL

Sep, 2017 Sigma and Vadodara by CAP

Oct, 2016 Sigma by NABL

Sep, 2015 Sigma and Vadodara by CAP

Sep, 2013 Sigma and Vadodara by CAP

July, 2012 Sigma by ANVISA

Aug, 2011 Vadodara by CAP

Aug, 2011 Sigma by CAP

Sep, 2010 Vadodara by CAP

Sep, 2009 Sigma by CAP

Sep, 2008 Vadodara by CAP

Sep, 2007 HQ by CAP

Last Inspection of Clinical Lab in Jan, 2018

Inspection of Clinical Lab in by ANVISA July, 2012

Last Inspection of Clinical Lab by NABL in Oct, 2017

Clinical Lab

Regulatory Inspections – Clinical Trials

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Regulatory Agency Inspection Date Location Inspection Area

USFDA Jan 16 – 18, 2018 Omaha, Nebraska, USA (Multicentric Clinical Trial) Clinical

USFDA Dec 11 – 13, 2017 Mumbai (Multicentric Clinical Trial) Clinical

USFDA Dec 04 – 08, 2017 Bangalore (Multicentric Clinical Trial) Clinical

USFDA Nov 15 – 18, 2017 Ahmedabad (Multicentric Clinical Trial) Clinical

USFDA Feb 20 - 24, 2017 Pune (Multicentric Clinical Trial) Clinical

USFDA Jan 23 - 26, 2017 Junagadh (Multicentric Clinical Trial) Clinical

USFDA Nov 7 - 10, 2016 Surat (Multicentric Clinical Trial) Clinical

USFDA Aug 15 - 19, 2016 Pune (Multicentric Clinical Trial) Clinical

USFDA Aug 8 - 12, 2016 Gandhinagar (Multicentric Clinical Trial) Clinical

USFDA Aug 25 - 28, 2014 Vadodara (Multicentric Clinical Trial) Clinical

USFDA Jul 28 - 31, 2014 New Delhi (Multicentric Clinical Trial) Clinical

USFDA Mar 24 - 27, 2014 Madurai (Multicentric Clinical Trial) Clinical

USFDA Feb 24 - 27, 2014 Nagpur (Multicentric Clinical Trial) Clinical

Our Global Services

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Early Phase & BA/BE

Bioanalytical, Small & Large

Molecule including Immunogenicity

and cell culture lab services

Late Phase/Multicenter

Clinical Trial Management

Pharmacovigilance & Medical Services

Clinical Laboratory (Asia)

Dermatology Specialty Testing

Environmental Exposure Chambers

Asthma, Allergy, Dry-eye syndrome

Biometrics - PK, PD, DM,

Biostatistics, Report Writing

Biologic and Biosimilar Program

Plan Development and

Program/Project Execution

Our Therapeutic experience: Oncology/Hematology, Dermatology, Psychiatry, Diabetology, Cardiology, Ophthalmology and Gastroenterology.

Clinical Data Management & Statistical solutions for a wide range of Therapeutic areas.

Key strengths:

Experience in complex late phase (I-IV) clinical trials, PK studies in patients and clinical data management services

Expertise in project management, site management, medical affairs, regulatory affairs, Clinical Trials Supply Management (CTSM) and Central lab services

Robust working relationship with more than 1500 + GCP trained investigators across various therapeutic areas

Team members bring along combined experience of > 100 years

Rich experience across various therapeutic areas with Paper and EDC studies

We have strong presence in USA, Canada, Europe(through partner) and India

Clinical Trials

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Clinical Operations

Supply Management

Biostatistics

Training

Quality Assurance

Medical Affairs and Writing

Data Management

Central Laboratory

Regulatory

Clinical Trials - Our Services

Clinical Trials - Operational Experience

Completed and Ongoing Trials

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Conducted over 4000 studies

12 clinical units, 513 beds, 16 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

BA/BE Studies

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Facility in India is well-equipped with a Bioanalytical Lab focusing on method development, validation and subject sample analysis using validated analytical methods

Over 350 analytical methods in biological fluids

28 LC/MS/MS (API 4000, 5500)

ICP-OES for elemental analysis

Over 4 million samples analyzed

Bioanalytical

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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

Dermatology

Expertise in:

Transdermal/Topical Bioequivalence

Contact Sensitization- Human Repeat Insult Patch Test (HRIPT)

Cumulative Irritation (14 and 21 day studies)

Wear studies

Skin Blanching (Vasoconstriction studies)

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Well experienced team of Biostatisticians, SAS Programmers, PK Scientists, Report writers and Report Compilators.

Experience in handling different clinical studies like Crossover, Parallel, Partial replicate, Fully replicate, Steady state, Two-stage bioequivalence studies and in-vitro bioequivalence studies.

PK/PD and statistical analysis using Phoenix® WinNonlin® and SAS® software.

Report writing as per ICH E3 format.

Study data submission in CDISC standards

Centralize report compilation as per eCTD standards.

PK, Biostatistics & Report Compilation

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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, Clinical chemistry, Immunology, Clinical Pathology, Flow Cytometry

Has stringent quality control programs in place and is strictly compliant with all applicable regulations.

Automated system from bar coding to bi-lateral interfacing of results to minimize any kind of clerical error.

Clinical Laboratory

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Team with expertise in method development and validation for Pharmacokinetic, immunogenicity and biomarker studies of Bio-similars. Validations are done as per GLP, FDA, EMEA guidelines.

Assay platforms

ELISA

CMIA

Clot based assays

Flow cytometry

End point kinetic assays

With our knowledge and experience comes the ability to work de novo, transfer and fully develop a client initiated assay and transfer a fully validated client assay.

Biosimilar bioanalysis

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We have the capabilities of detecting anti drug antibodies by three tiered evaluation approach.

• Screening assay

• Confirmatory assay

• Neutralization assay (Cell based assay)

Cell culture lab for detection of neutralization antibodies.

Our biomarker offerings include a range of therapeutic areas to include:

Numerous vaccine studies have also been conducted

Immunogenicity and biomarker testing

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• CVS • CNS • Metabolic disorders

• Inflammatory markers • Oncology

Quality Assurance (QA)

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

Confirms compliance to: Protocol, SOPs & Regulatory guidance

System & vendor audits

Ensures audit of each study’s source data

Revisions of Standard Operating procedures are scrutinized by QA

Resolution of regulatory queries

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Project inquiry followed by Feasibility

Assessment

Cliantha signs agreement

Protocol preparation Client approval of

protocol

IEC/DCGI approval of protocol

Subject screening

Clinical Phase: Subject housing, dosing, sampling,

discharge, ambulatory samples

Sample analysis

CDM, PK & statistical analysis

Draft report to client Final report to client Archiving

Project flow

Set-up weekly calls for regular study updates

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Day 0 -7 8-14 15-21 22-28 29-35 36-42 43-49

Week W1 W2 W3 W4 W5 W6 W7

Project Confirmation

Protocol finalization & EC Approval

BE NOC/T-License

MD/MV (if applicable)

Typical Timeline chart

(Assumptions: No. of subject: 36, No. of periods: 2,Washout period: 7 days; Delivery in < 113 days)

Day 50-56 57-63 64-70 71-77 78-84 85-91 92-98 99-105 106 -113

Week W8 W9 W10 W11 W12 W13 W14 W15 W16

IP Transfer

Clinical Phase completion

Bio-analysis

PK/Statistics

Draft report

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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

• This product is approved by USFDA

Case study - 1

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

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Challenges Planning and Execution

• Sublingual administration of IP with observation up to 10 minutes to ensure proper dosing.

• Dedicated doser and supervisor for each subject.

• Every minute blood sample collections till peak level of Cmax (10-15 minutes).

• Dedicated phlebotomist for each subject with standby phlebotomist.

• Centrifugation within 2 minutes of sample collection

• Dedicated centrifuge machines for each time point arranged near to collection area with standby.

• Plasma samples to be immediately shock frozen in a Ethanol/dry ice bath –75ºC ± 15ºC

• Arrangement of racks containing dry ice / Ethanol with attached data logger for continuous temperature monitoring at the sample separation site.

• Specially treated glass tubes for plasma and overseas shipment

• Procured from Bioanalytical facility and shipped in specially designed Armcool boxes and wrapped to avoid breakage.

Case study - 2

Nitroglycerine study: (Tmax: 6-7 minutes)

Extensive Planning and coordination with different dept for Manpower and Infrastructure.

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Challenges Planning and Execution

• 17 days housing duration • Identification of specific pool of volunteers

• Diet equilibrium period with fluid intake • Specific meal menu to meet the daily intake of

Potassium, Sodium and Calories) and fluid intake (3,000 to 5,000 mL/ day) requirements

• Urine collection at different time interval

• Different size of urine pot, Jar, container with specific labeling

• Critical IP administration procedure (i.e Four/ Eight capsule administration with/ without apple sauce)

• Trained dosers and detailed discussion of IP administration procedure with volunteer

Case study - 3

Potassium Chloride (KCL study): 17 days housing study with diet equilibrium period

Extensive Planning and coordination with different dept for Manpower and Infrastructure.

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Why Cliantha?

Steady core team since inception

Robust e-learning system, only CRO with a dedicated and centralized training team (Get a sneak peek: Training process)

International presence with extensive set-up in North America and India

Facilities successfully audited and inspected by both national and international Regulatory bodies

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Team

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Vijay Patel Executive Director 26 years Management experience

Naveen Sharma President 23 years Research experience

Anita Kaul Vice President, Operations 28 years Clinical experience

Hitesh Chauhan Head - Biometrics 18 years of Statistics & CDM experience

Anshul Dogra Head, Bioanalytical Lab 17 years Bioanalytical experience

Dr. Chirag Shah Director - Late Phase Trials 18 years of Research experience

Dr. Shaifali Gupta Head, Central Reference Lab 17 years Pathology experience

Dr. Dharmesh Domadia Associate Vice President, Global Clinical Operations 15 years Clinical experience

Arpana Prasad Head, Quality Assurance 20 years Research experience

Rahul Nijhawan Sr. Director - Early Phase 17 years Research experience

Nayan Prajapati Head, Training 9 years of Research / industry experience

Our Assets

Cliantha team 700 and growing…including 20 doctors

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

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Facilities - India

Cliantha, HQ; Ahmedabad

Cliantha, Vadodara

Go Back

Cliantha, Sigma; Ahmedabad

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Cliantha, Noida

Facilities – USA and Canada

Go Back

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Hill Top Research, St. Petersburg, FL

Facilities – USA and Canada

Go Back 35

Hill Top Research, Toronto, ON Hill Top Research, Winnipeg, MB

Hill Top Research, Neptune, NJ Hill Top Research, Canada

Thank You

www.cliantha.in

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