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cliantha.com

USA | CANADA | EUROPE | INDIA

Corporate Presentation

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About us

Global CRO providing comprehensive & integrated offerings

3 Continents, 4 Countries, 9 Offices

Steady core team backed by 1000+ dedicated full time experienced professionals across the group

Impeccable regulatory track record

Robust e-learning system

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Full

Service

CRO

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Global Footprints

CANADA • Winnipeg • Scarborough • Mississauga

USA • St. Petersburg • New Jersey

EUROPE • Portugal

INDIA • Ahmedabad • Delhi (NCR) • Vadodara • Mumbai • Hyderabad

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Milestones

Acquired Hill Top Research, North America

Acquired Karmic Lifesciences, India

Acquired Inflamax Research, North America

…pathways to

our growth

Initiated Clinical Trials

Established Clinical, Bioanalytical and Statistical services at Ahmedabad

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Centres of Excellence

Early phase

Late phase

Biometrics

Respiratory

Dermatology

Pharmacovigilance & Medical Services

Lab Services

Consumer Research

Tobacco Trials

eClinical

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Location Specific Services

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Global Regulatory Track Record

* Includes 34 Multicentric Sites (1: USA & 33: India)

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2 1 1

1 1 1

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Phase I & BA/BE Experience & Capabilities

Type of Study No. of Studies

Bioavailability & Bioequivalence (BA/BE) 5866

First-in-human (FIH) 31

Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) 27

Drug-Drug Interaction (DDI) 24

PK/PD 23

Food Effect 15

• 3 locations: Ahmedabad, Noida & Vadodara

• 12 clinical units, 513 beds, 14 ICU beds & 25 doctors

• Central Lab accredited by CAP • 55,000 healthy subjects

database

• 1 Location: St. Petersburg, FL 48 beds

• Utilize local central laboratory

• 1 location: Mississauga • 3 clinical units, 97 beds, 8 ICU

beds • Local central laboratory • 8,200+ HNV database • Access to special populations in

respiratory & allergy diseases • 13,500+ Total patient database.

Cliantha Research India

Cliantha Research USA

Cliantha Research Canada

MOUs with leading corporate hospitals & successful seamless execution of studies

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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

Phase Experience with Route of administration

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BA/BE- Bioanalytical - Small Molecule

Active participation in global bio-analytical events (like WRIB, APA etc)

• Two facilities:

• Ahmedabad (India) & Toronto (Canada)

• 450+ Bioanalytical methods in biological fluids

• Over 6 million samples analyzed

• 38 LC/MS/MS

• API 4000, API 5500,API 6500

• Front end Variants : HPLC & UFLC

• ICP-OES for elemental analysis

• Upright freezers (-70° C)

• Walk in freezers (-20° C)

• Digital temperature monitoring system.

• Dedicated Method development – Validation Lab

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PK, Biostatistics & Report Compilation

• 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

• Centralized report compilation as per eCTD standards.

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Clinical Trial Services

Clinical Operations

Supply Management

Biostatistics

Quality Assurance

Training

Project Management

Medical Affairs and Writing

Data Management

Central Laboratory

Regulatory

Pre-Study Feasibility

Pharmacovigilance

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Global Presence

• US, Canada and India:

– Physical presence in form of offices

– Presence of Project Managers & CRAs

– Capable to manage any Phase I-IV studies in the mentioned geographies

– Also pioneer in EEC studies for Allergic Rhinitis

• Europe:

– Presence across Central and South Eastern Europe through a strategic partner

– Project Manager in Portugal

• Russia:

– Presence in Russia through a strategic partner

• Asia Pacific:

– Presence across South East Asia and Australia through a strategic partner

• South Africa:

– Presence in South Africa and African continent through a strategic partner

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Late Phase - Clinical Trial Experience

• 71 studies across geographical locations

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Late Phase – Phase-wise & Regulatory Exp.

34 USFDA Inspections

CT Phase experience

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*33- India & 1- USA

Regulatory submissions

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Data Management

Nervous system disorders (3) Renal and urinary disorders (3) True test Patch (3) Blood and lymphatic system (2) Hepatobiliary disorders (2) Immune system disorders (2) Pain (2) Musculoskeletal (2) Hormone Replacement Therapy (1) Overall wellness (1)

Dermatology (17) Oncology (14) Endocrine and Metabolism (12) Psychiatric disorders (7) Ophthalmology (7) Gynecology (6) Infections and infestations (7) Vaccine (5) Cardiac disorders (4) Gastrointestinal disorders (4) Respiratory (4)

• End to end services for complete data management • 40+ experienced Data Manager/ Clinical Database Programmer • Proprietary Clinical data management platform “Code Angelo” 21 CFR part 11

compliant system, Medrio, Inform, SAS Pheedit, Acceliant, Oracle Clinical (OC-RDC), Medidata Rave, Amedon

• Experience: • Phase I-IV including BA BE & personal health care trials • Patient population ranging from 20 - 25000 • Study duration ranging from 1 month to 5 years • eCRF & paper CRF model • Different therapeutic areas:

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Biostatistics & Programming

• 40+ trained Biostatistician/SAS programmers

• Wide experience in various therapeutic categories

• 40+ trained Biostatistician/SAS programmers

• Wide experience in various therapeutic categories

Software: • Server SAS V9.4 • WinNonlin 6.4 • nQUERY Advance • R studio

Clinical trial and PHC Studies • All phases and BE clinical

endpoints

• DRC, VASO

• Adhesion / Irritation / Sensitization

• All Claim Studies stats

Deliverables • Sample size calculation /re-

estimation • Trial design/endpoint

evaluation • SAS Rando code

(permutated / adaptive) • Creation of SAP • Non-standard stats • SAS TLFs (dual programming) • ISS/ISE • IDMC data support • DSUR / IB / PV signal

detection SAS

CDISC Services • SDTM 3.2 • ADaM 1.1 • Define.xml 2.0

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CAP Accredited Central Lab Services

• Our service capabilities extend to support Multicentric Clinical Trials. • Microbial testing services extend for food, beverages, cosmetics, personal

care/home/surface care products.

Hematology

Clinical chemistry

Coagulation Clinical pathology

Immunology

Flow cytometry

Microbiology

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Large Molecule Services

The comprehensive lab services span from • Large molecule PK • Immunogenicity • Neutralization assay • Biomarker assessment • Cell culture lab services including PBMC

isolation, NK cell activity • Vaccine science

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Biosimilars Bioanalysis

• Team with expertise in method development and validation for Pharmacokinetic, immunogenicity and biomarker studies of Biosimilars.

• Validations are done as per GLP, FDA, EMA guidelines.

• The comprehensive lab services span from • Large molecule PK • Immunogenicity • Central lab testing biomarker assessment • Vaccine science • Cell Based assays (including neutralizing assays)

• Assay platforms

• ELISA

• CMIA

• Clot based assays

• Flow cytometry

• End point kinetic assays

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Pharmacovigilance Offerings

Medical Information Management System

Clinical Trial Safety Monitoring

Post Marketing Pharmacovigilance

Services

PV Support Services

• Patient Support Call Center

• Medical Inquiry Handling

• Categorizing Inquiries & Responding

• Inquiry Close Out

• SAE Processing & Reporting

• Safety Listing Review • Clinical Safety

Meetings • DSUR

• ICSR Processing • Literature

Monitoring • Aggregate Reporting • RMP, REMS • PSMF, XEVMPD • Product Label, CCDS

• Auditing & Inspection Support

• E-Training System • Quality

Management System

• Document Support • Consultation

Experienced MDs on board

Medicinal Products

Medical Devices

Human Vaccines

Cosmetovigilance Herbal Products/ Nutraceuticals

Veterinary Vigilance

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Personal Healthcare Capabilities

Safety / Sensitivity

Testing

Efficacy & Claim

Substantiation

Nutraceuticals, Dietary

Supplements

Home Care Functional

Foods

Skin Care & Anti-Aging

Oral Care, Hair Care,

Eye Care,

Deodorant & Antiperspirant

Testing

- St. Petersburg (USA) - Winnipeg (Canada)

- Ahmedabad, India

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Why Cliantha?

Various Therapeutic Areas Experience

• A team of veterans in most of the therapeutic areas

Consistent and Regular Training

• Robust e-learning system, only CRO with a dedicated and centralized training team

India, US and Partners in EU, South Africa and APAC Global

• International presence with extensive operations in North America and India

Audited by International Regulatory Authorities Integrity

• Facilities and sites successfully audited and inspected by both national and international regulatory bodies including FDA

Thank You