Full Service CROFull Service CRO

Cliantha is an independent global Contract Research Organization (CRO)

providing an integrated clinical offerings in Early Phase (Phase I/IIa), LatePhase (Phase II-IV), Bioequivalence (BA/BE), Clinical Endpoint Trials,Bioanalytical, Biosimilars, Oncology, Dermatology, Biometrics, and Personal

Healthcare services. Our services have science at its foundation developedthrough regular and systematic training of the Cliantha team.

Cliantha Research offers Biotech, Cosmetic, Generic, Personal Healthcare andPharmaceutical companies a comprehensive range of clinical research andsupport services. You will notice we use our legacy brand names: Cliantha

Research, Hill Top Research and Karmic Lifesciences, however, we operateas one company Cliantha. We have added and enhanced capabilities duringthe past 5 years in each of the companies to provide our sponsors with a

single, global research network.

About Us

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http://www.cliantha.in/http://www.cliantha.in/http://www.cliantha.in/http://www.hill-top.com/http://www.hill-top.com/http://www.hill-top.com/http://www.hill-top.com/http://www.hill-top.com/http://www.karmiclifesciences.com/http://www.karmiclifesciences.com/http://www.karmiclifesciences.com/

Cliantha locations

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EUROPE, SOUTH AMERICA AND SOUTH AFRICA EUROPE, SOUTH AMERICA AND SOUTH AFRICA THROUGH PARTNERSTHROUGH PARTNERS

CANADA

INDIA

St. Petersburg Ahmedabad Vadodara

Toronto

Winnipeg

Mumbai

New Delhi

Submissions

> 90% for US (FDA) and the EU (EMA)

Canada

India

Japan

South Africa

Russia

Australia

WHO

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GLOBALLY DIVERSEGLOBALLY 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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Government of IndiaFacilities 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 SpainInspected facility in Jan 2009 by MCC

Last Inspection in Nov 2015 by Austria(2 times)

Inspected facility in Feb & Mar 2013 by UK MHRA

Inspected facility in July 2013 by Thai MOH

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

Last inspection in Nov-Dec 2016 by USFDA(15 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 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

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

Date Inspection details

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

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Clinical Lab:

Last Inspection of Clinical Lab in Sep, 2015

Inspection of Clinical Lab in by ANVISA July, 2012

Last Inspection of Clinical Lab by NABL in Oct, 2016

Regulatory Inspections Clinical Trials

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Regulatory Agency Inspection Date Location Inspection Area

USFDA Feb 20 - 24, 2017Pune

(Multicentric Clinical Trial)Clinical

USFDA Jan 23 - 26, 2017Junagadh

(Multicentric Clinical Trial)Clinical

USFDA Nov 7 - 10, 2016Surat

(Multicentric Clinical Trial)Clinical

USFDA Aug 15 - 19, 2016Pune

(Multicentric Clinical Trial)Clinical

USFDA Aug 8 - 12, 2016Gandhinagar

(Multicentric Clinical Trial)Clinical

USFDA Aug 25 - 28, 2014Vadodara

(Multicentric Clinical Trial)Clinical

USFDA Jul 28 - 31, 2014New Delhi

(Multicentric Clinical Trial)Clinical

USFDA Mar 24 - 27, 2014Madurai

(Multicentric Clinical Trial)Clinical

USFDA Feb 24 - 27, 2014Nagpur

(Multicentric Clinical Trial)Clinical

Our Services

Clinical Trials BA/BE Studies Dermatology

PK Large molecules - PK & Immunogenicity

testing

PK, Biostatistics & Report Compilation

Clinical Laboratory

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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 Trials - Our Services

Clinical Operations

Medical Writing

Quality Assurance

Clinical Data Management

CTSM

BiostatisticsClinical

Laboratory

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Clinical Trials - Operational Experience

Completed and Ongoing Trials

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Conducted over 5000 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 250 analytical methods in biological fluids

28 LC/MS/MS (API 3000,4000, 5500)

ICP-OES for elemental analysis

Over 3 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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PK parameter estimation using WinNonlin

Statistical analysis using SAS software

Well experienced team of Biostatisticians, SAS Programmer, Report writer and Report Compilator

Experience in handling different crossover, Parallel, Partial replicate, Fully replicate, Steady state bioequivalence studies

Study data submission in CDISC standards

Report writing as per ICHe3 format.

Centralize report compilation as per eCTDstandards.

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, Coagulation, Clinical chemistry, Immunology, Serology, 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 ELISA based method development and

validation for Pharmacokinetic studies and immunogenicity of

Bio-similars. Validations done as per GLP, FDA, EMEA guidelines.

Methods validated:

Levothyroxine (Reference range - 3.500 ug/dL - 25.00 ug/dL)

Tri-iodo thyronine (Reference range 0.5 ng/ml - 20 ng/ml)

Erythropoeitin (Reference range is 3.5 600 mIU/ml)

Methods developed:

Bevacizumab (Reference range 2-200 g/ml)

Teriparatide (Reference range 20-230 pg/ml)

Rituximab (Reference range is 1.5 to 240 ug/ml in neat serum)

FSH

Darbaepoeotin

Trastuzumab

GCSF

Iron sucrose

Large molecules - PK

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Capabilities of detecting anti drug antibodies by three tiered evaluation approachwhich includes :

Anti drug antibody screening test Positive ADA confirmation test

Titration

Immunogenicity testing

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Biomarker testingOur biomarker menu of biomarker offerings include a range of therapeutic areas to include:

Cardiovascular Central nervous system (CNS) Metabolic disorders Inflammation Oncology

Biomarkers validated include

CD 34 for Peg G-CSF. Anti-factor IIa Anti-factor Xa Hep test TFPI for LMWH Hb, Hct, Reticulocyte count, ANC

Numerous vaccine studies also conducted

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 studys 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 clientArchiving

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 99-105106 -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

MilestonesFasting 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

Bioanalysisends

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 75C 15C

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 and Demo module)

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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http://www.cliantha.in/elearning/index.htm

Team

Vijay PatelExecutive Director 23 years Management experience

Naveen SharmaPresident20 years Research experience

Anita KaulVice President, Operations26 years Clinical experience

Hitesh ChauhanHead - Biometrics 16 years of Statistics & CDM experience

Anshul DograHead, Bioanalytical Lab 15 years Bioanalytical experience

Dr. Chirag ShahDirector - Late Phase Trials17 years of Research experience

Dr. Shaifali GuptaHead, Central Reference Lab16 years Pathology experience

Dr. Dharmesh DomadiaAssociate Vice President, Global Clinical Operations13 years Clinical experience

John L. CapicchioniChief Commercial Officer26 years of industry experience

Arpana PrasadHead, Quality Assurance18 years Research experience

Rahul NijhawanSr. Director - Early Phase15 years Research experience

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Nayan PrajapatiHead, Training9 years of Research / industry experience

Our Assets

Cliantha team700 and growingincluding 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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Thank You

www.cliantha.in

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