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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
Cliantha locations
© 2017 Cliantha. 03
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
© 2017 Cliantha. 04
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
© 2017 Cliantha. 05
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
© 2017 Cliantha. 06
Safety for all
© 2017 Cliantha. 07
Pharmacovigilance Offerings
© 2017 Cliantha. 08
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
© 2017 Cliantha. 09
Medical Information Management System
Patient Support Call Center
Medical Inquiry Handling
Categorizing Inquiries & Responding
Inquiry Close Out
Medical Information Management System
© 2017 Cliantha. 10
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
© 2017 Cliantha. 11
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
© 2017 Cliantha. 12
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
© 2017 Cliantha. 13
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
© 2017 Cliantha. 13
Regulatory Coverage
© 2017 Cliantha. 14
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
© 2017 Cliantha. 15
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
© 2017 Cliantha. 16
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
© 2017 Cliantha. 17
Functional Team @ Cliantha
Sponsor Business
Development Quality
Assurance
Large pool of short listed safety professionals CVs is available for easy recruitment
© 2017 Cliantha. 18
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
© 2017 Cliantha. 19
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
© 2017 Cliantha. 20
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
© 2017 Cliantha. 21
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)
© 2017 Cliantha. 22
Team
Vijay Patel
Executive Director
vijay@cliantha.in
Naveen Sharma
President
nsharma@cliantha.in
Dr. Dharmesh
Domadia
Asso. Vice President– Global Clinical operations
ddomadia@cliantha.in
Ali Bolat
Business Development
abolat@cliantha.in
Rahul Nijhawan
Sr. Director - Early
Phase
rnijhawan@cliantha.in
Ravindra
Gandham
Business Development
rgandham@cliantha.in
Dr. Ripal Gharia
Pharmacovigilance & Medical
Services
rgharia@cliantha.in
Atul Phatak
Business Development
aphatak@cliantha.in
Tarun Jain
Business Development – Pharmacovigilance
tjain@cliantha.in
Dr. Chirag Shah
Director – Late Phase
Trials
cshah@cliantha.in
THANK YOU
© 2017 Cliantha.
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