A FULL SERVICE GLOBAL CRO - · PDF fileCliantha is an independent global Contract Research Organization (CRO) providing an integrated clinical offerings in Early Phase (Phase I/IIa),

A FULL SERVICE GLOBAL CRO PHARMACOVIGILANCE SERVICES

© 2018 Cliantha

About Us

Cliantha is an independent global Contract Research Organization (CRO)

providing an integrated clinical offerings in Early Phase (Phase I/IIa), Late

Phase (Phase II-IV), Bioequivalence (BA/BE), Clinical Endpoint Trials,

Bioanalytical, Biosimilars, Oncology, Dermatology, Biometrics, Regulatory

Services and Personal Healthcare services. Our services have science at its

foundation 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.

© 2017 Cliantha. 02

hill-top.com

karmiclifesciences.com

inflamaxresearch.com

Cliantha locations


New Delhi

Mumbai

Ahmedabad

Vadodara

India

Portugal

Canada

Winnipeg

Toronto

New Jersey

St. Petersburg

Europe, Asia Pacific and South Africa through partners

Cliantha Full Service Global CRO


Cliantha Research Full Service Global CRO

EARLY PHASE (Phase I/IIa, BA/BE, PHC, EEC, PV)

BIOMETRICS (CDM, Biostatistics and CDISC)

Karmic Lifesciences

India North America Canada India North America

LATE PHASE (Phase II-IV, PK, TEQ, EEC)

India North America

Ahmedabad

Mumbai

St. Petersburg

Toronto

Ahmedabad

Mumbai

Toronto Ahmedabad 196 Beds, 28

LCMS/MS Clinical Lab Toronto

Inflamax

Research

100 Beds & EEC

Cliantha

Research

5 LCMS/MS

Winnipeg

PHC

Vadodara 200 Beds Clinical Lab

Noida 117 Beds Clinical Lab

St. Petersburg Hill Top Research 50 Beds & PHC

New Jersey Hill Top Research

100 Beds

Ahmedabad PHC - Karmic Lifesciences


Our Global Services

Early Phase & BA/BE

Bioanalytical, Small & Large Molecule Including Immunogenicity

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

Accreditations & Inspections


Safety for all


Pharmacovigilance Offerings


Medical Information Management System

Clinical Trial Safety Monitoring

Post Marketing Pharmacovigilance

System

PV Support Services

Medicinal Products

Medical Devices

Human Vaccines

Cosmetovigilance Herbal/Nutraceuticals Products

Veterinary Vigilance



Patient Support Call Center

Medical Inquiry Handling

Categorizing Inquiries & Responding

Inquiry Close Out



Clinical Trial Safety Monitoring

DSUR/PSUR

SAE Processing

Safety Management Plan (SMP)

SAE Medical Review

SAE Reporting

Safety Listing Review

Drug Safety Monitoring Board (DSMB)

Risk Management Strategies


Cliantha Experience for Clinical Trial Safety Reporting

Therapeutic Area by Percentage

Oncology

Gynaecology

Immunology

Dematology

Psychiatry

Gastroenterology

Nephrology

Respiratory

Urology

Rheumatology

Ophthamology

Cardiovascular

Neurology

35

13

52

0

20

40

60

Asia Europe USA

Percentage of submissions

Percentage of submissions

% of Trials Experience by Phase

Phase 1

Phase 2

Phase 3

Phase 4


Post Marketing Pharmacovigilance Services

Safety Data Exchange Agreement (SDEA)

Risk Management Plan (RMP)

Risk Evaluation & Mitigation Strategy (REMS)

XEVMPD

PSMF

Individual Case Safety Report (ICSR)

QPPV and LRPV Support

Aggregate Report

Product Labels /CCDS preparation


Flow of Activities in PV

Case Input

Regulatory Literature Spontaneous Clinical Trials

Case Intake

Validity Check Duplicate Check Triaging Database

Case Processing

Data Entry Quality Review Medical Review Case Closure

E2B XML MedWatch CIOMS Appendix-XI

Case Output

Case Processing Flow

Aggregate Reporting: Outcome Analysis

PSUR, PBRER,PADER, ACO RMP, REMS, PRAC Signal Management Activity


Regulatory Coverage


PV Safety Database

Regulatory Compliant Safety Solution –

used by CROs, drug companies & Consultancies

Customizable, dynamic

case workflow and User

friendly

20+ CROs and 65+

drug companies like GSK,

MSD, Novartis etc using

the database globally

Allows case processing for

drugs, devices, vaccines,

cosmetic and veterinary


Other PV Domains

Cosmeto-vigilance Herbal/Nutra-vigilance Veterinary vigilance

Prolific Experience >300+ cosmetics & herbal Studies

Knowledge of processing Undesirable Experiences (UEs) & Serious Undesirable Experience (SUEs) for

Cosmetic cases

Adheres to regulatory agencies like USFDA, EU, CDSCO & Health Canada

Team of subject matter experts capable of delivering high quality services


PV Support Services Auditing & Inspection Support

E-Training System

Quality Management System

Documentation Support (SOPs and Others)

Consultation

Head – Medical Services

Dedicated Account Manger

QPPV

Quality Review Team

Submission Team

Aggregate Report

(AR) Team

Medical Reviewer

Team

Case Management

Team


Functional Team @ Cliantha

Sponsor Business

Development Quality

Assurance

Large pool of short listed safety professionals CVs is available for easy recruitment


Service Modus Operandi

Authorization Based Model

Per molecule charge (Prefixed amount)

Monthly or quarterly invoiced

Covers routine PV services (ICSR, AR etc.)

Case Based Model

Per case charge, per report charge Monthly or quarterly invoiced

Applicable for all PV services or standalone

Full Time Employee (FTE) Model

Sponsor dedicated team for dedicated operation

Can work onsite and/or offsite

Customizable and/or efforts per man hour costing models as per sponsor’s requirement can be discussed


Sponsor Audit Process

Sponsor

Intimation for procurement/ assessment

audit

Cliantha’s QA Team

QA team will initiate the

process of Audit

Review of System

Docket inclusive of PV Ops, QA &

Training

Closeout/Client Specific requirements

Docket inclusive of PV Ops, QA &

Training


We believe in serving the BEST

A to Z of PV

services

Regulatory Compliant Systems

Years of Trust & relationship

Flexible and Customer

Centric Approach

Enthusiastic & experienced

team

Dedicated medical safety writers with expertise in drafting PSUR/PBRER, PADERs, RMPs, REMS, DSUR

Wide spread LRPV network & medical support

Strong regulatory intelligence system

Committed to continuous process improvements with more than 45 PV SOPs

Proficient in Pre & Post marketing PV obligations for Drug, Device, Vaccines

SUCCESS


Medical Writing & Regulatory Affairs

Medical Oversight Medical Writing Scientific Writing

Medical Overview of

the clinical trials

Training of Study

Teams and sites

SEC meetings at

DCGI

On site monitoring

Central Monitoring

Protocol

Clinical Study

Report

Informed Consent

Documents

Subject Diaries

eCTD Modules

Briefing documents

for regulatory

authorities

Manuscript writing

Conference abstracts &

Presentations

Medico marketing aids

and presentations

Meta-analysis

Web synopses

(Clintrial.gov, EU clinical

register etc)


Team

Vijay Patel

Executive Director

[email protected]

Naveen Sharma

President

[email protected]

Dr. Dharmesh

Domadia

Asso. Vice President– Global Clinical operations

[email protected]

Ali Bolat

Business Development

[email protected]

Rahul Nijhawan

Sr. Director - Early

Phase

[email protected]

Ravindra

Gandham


[email protected]

Dr. Ripal Gharia

Pharmacovigilance & Medical

Services

[email protected]

Atul Phatak


[email protected]

Tarun Jain

Business Development – Pharmacovigilance

[email protected]

Dr. Chirag Shah

Director – Late Phase

Trials

[email protected]

THANK YOU

© 2017 Cliantha.