Pharmacovigilance

Pharmacovigilance

Cliantha PV capabilities
  • A to Z of PV services
  • Regulatory Compliant Database
  • Years of Trust & relationship – Science and integrity
  • Flexible and Customer Centric Approach – Customer First
  • Enthusiastic & experienced team – Our People are our treasure
  • Remote Audit Support for Clients – eDocument Viewer Management System
  • Easily Approachable Pharmacovigilance System Master File – ePSMF
  • Strong Regulatory Intelligence System
Domains Catering
  • Medicinal Product

    Medicinal
    Product

  • Medical Devices

    Medical
    Devices

  • Human Vaccines

    human
    vaccines

  • Cosmetovigilance

    Cosmetovigilance

  • Herbal Product

    Herbal/Nutraceuticals
    Products

  • Veterinary

    veterinary
    vigilance

We cater Pharmacovigilance requirement for every stage of product development.
  phase
01
phase
02
phase
03
phase
04
PV/Risk Management Plan icon1 icon1 icon1 icon1
SAE/ADR/MDR Management icon1 icon1 icon1 icon1
Medical Monitoring icon1 icon1 icon1 icon1
Definition of Safety Profile/ Benefit-
Risk Assessment
icon2 icon2 icon2 icon2
Development Safety Update Report icon4 icon4 icon4  
Data Pooling/Data Monitoring Boards icon1 icon1 icon1 icon1
Pooled Analysis   icon4 icon4 icon4
Integrated Analyses of Safety/ Efficacy     icon3  
Periodic Safety Update Reports       icon4
Post-Authorization Studies       icon4
icon1

Occurs
throughout

icon2

Occurs at non-
specified intervals

icon3

Occurs
once

icon4

Occurs at specified
intervals

Medical Information Safety Management
  • Patient Support Call Center (Set up of Toll Free Number for counties like US, Canada, India) etc
  • Inquiry Handling and segregation in product inquiry, product complaint and adverse event
  • Response of Queries appropriately
Clinical Trial Safety Management
  • Safety Management Plan (SMP) Preparation
  • SAE Processing
  • SAE Medical Review
  • Safety Listings Review
  • Drug Safety Monitoring Board (DSMB) Handling
  • Risk Management Strategies
  • DSUR (Development Safety Update Report)/ASR (Annual Safety Report)
PV Support Services
  • Auditing & Inspection Support
  • E-Training System
  • Quality Management System
  • Documentation Support (SOPs and Others)
  • Consultation
Post Marketing Pharmacovigilance Services
Adverse event (AE) management
  • Intake
  • Triage
  • Case processing (Cliantha or client-provided database)
  • Medical Coding
  • Narrative development
  • Medical review
  • Follow-up collection
  • AE reconciliation with call center
Safety database services
  • Database setup, implementation and maintenance
  • Data migration
Literature Management
  • Review of articles for inclusion in ICSRs, aggregate reports and signal detection
  • Review of local literatures and translations
  • Literature search -Toxicology reports
    • Medical devices
    • Product development programs
    • Mitigation of medical practices lawsuits
Individual case reporting
  • Post-approval (e.g., (S)ADR, SUSAR) reporting to regulatory authorities
Aggregate report management
  • Development (e.g., PBRER, EC2-R1 PSUR, PADER)
Signal management
  • Detection
  • Validation
  • Evaluation
  • Tracking
Region-specific Services
  • EudraVigilance profile management
  • European Union-qualified person for pharmacovigilance (QPPV)
  • In-country pharmacovigilance services, including national contact persons(RP)/QPPVs and local literature surveillance
Risk Management Activities
  • Risk Management Plans (RMP)
  • Risk Evaluation & Mitigation Strategy (REMS)
Product Labels
  • CCDS/CCSI
  • PI, SmPC etc
Agreements
  • Safety Date Exchange Agreements
  • Legal Representative Agreements
E2B R2-R3 Conversion
  • Conversion of cases from R3 to R2 format and vise a versa
  • Selection of valid and non-valid cases

Regulatory Inspections

Goverment of India Facilities inspected & approved by Drugs Controller General of India
Last inspection in Nov 2015 by
Austria (2 times)
Inspected facility in Nov 2006 by
ANSM
Inspection facility in jan 2009 by
MCC
Last inspection in March 2017 by
USFDA (17 times)
Last inspection in April 2017 by
UK MHRA (2 times)
Last inspection in March 2013 by
WHO (3 times)
Inspected facility in July 2013 by
Thai MOH
Last inspected by Ministry of Health of Turkey in April 2013
Inspected facility in April 2011 by
Spain