Pharmacovigilance & Medical Services

  • Pharmacovigilance
  • Medical Services

Pharmacovigilance

Our Pharmacovigilance Services

Highlights of Cliantha PV capabilities

Domains Catering

Medicinal Product
Medical Devices
Human Vaccines
Cosmetovigilance
Herbal/Nutraceuticals Products
Veterinary Vigilance

Solutions delivered with integrity at every stage of product development

Development Phase PV Plan/RMP SAE/ADR/MDR Management Medical Review Risk-Benefit Evaluation DSUR/IND Report Safety Monitoring Board Integrated Safety Summary PSUR Post Authorization Safety Studies Signal Detection
Phase I
Phase II
Phase III
Marketing Authorization
Post Marketing

1. Medical Information Safety Management

Flow of Medical Inquiry Handling
Multi-Channel Medical Information Handling
  • Compliant with: telephone, email, fax and letter, social media platforms.
  • CRL can also design, create and host a medical information website or portal for your company or individual products.
Multilingual Call Handling Services
  • Compliant with English, French, Hindi, Gujarati etc. Other languages can be supported by utilizing an in-line translation service.
Query Management System
  • Frequently Ask Questions (FAQs) and Standard Response Document creation and maintenance
  • Adverse Event and Product Quality Complaint Handling according to client specific operational guidance documents
Out of Hours Service Provision
  • In addition to covering standard business hours of operation, CRL can provide a 24 hour service, 365 days a year if required, ensuring you a round-the-clock medical information service

2. 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

Safety Management Plan (SMP) Preparation

DSUR (Development Safety Update Report)/ASR (Annual Safety Report)

Experience of Clinical Trial Safety MonitoringExperience of Clinical Trial Safety MonitoringExperience of Clinical Trial Safety Monitoring
Phase of Study Indications/Molecules Total Number of patients
Phase I Peg-GSCF, Erythropoietin, Darbepoietin, Bevacizumab, Trastuzumab etc. 536
Phase II NSCLC 70
Phase III NSCLC, DLBCL, MBC, NHL, mCRC, Solid Tumors, CML, Anemia of Cancer, Fibroid, Functional Dyspepsia, COPD, Hypertension, 2300
Clinical Equivalence Acne, Osteoarthritis knee, Scabies 4350
Patient based PK study Schizophrenia, MBC, Parkinson’s disease, Epilepsy, HIV, RA, CML 560
Our Expertise
  • Leaders in oncology & biosimilars
  • Phase I-IV, Patient based PK & CE studies
  • Clinical Trial Safety Management experience for USFDA, EMEA, DCGI etc
  • Expertise of handling the safety profile of 7800+ patients across various studies

3. Post Marketing Pharmacovigilance Services

1. Literature Management
  • Review by Medically qualified personnel
  • Peer review and quality review
  • 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
Literature Review Activity
  • Setting of RSS string in Pubmed/Embase
  • Dedicated e-mail ID for literature hits receipt
  • Hits evaluated on weekly basis by Medically Qualified Person
  • Assessment of Full Text requirement
  • Valid ICSRs as per regulatory requirement and client conventions will be transmitted to case processing team
  • Quality check of entire process on ongoing basis
  • Maintenance of tracker and folders on ongoing basis
  • Quality Assurance review of entire process as per Audit Planner
2. ICSR Management
  • Unique Offerings:
  • Validity Check of ICSR by Medically Qualified Personnel before ICSR generation in database
  • Triaging by Medically Qualified Personnel
  • Independent Quality Check of 20% ICSRs each month
  • Periodic updates to the client as per requirement
ICSR Project Management
  • Understanding Client Requirements
  • Mapping of regulatory requirements for case submission
  • Identification of the core team & training on client conventions
  • Setting of targets and tracking mechanism
ICSR Database Flow
Case Input
  • Spontaneous cases
  • Literature
  • Solicited (Clinical Trials/Registry/PMS etc.)
  • Regulatory
Case Intake
  • Validity Check
  • Duplicate Check
  • Book – in to Database
  • Triaging
Case Processing
  • Data Entry
  • Quality Review
  • Medical Review
  • Case Closure
Case Output
  • CIOMS - 1
  • E2B R2 & R3 xml
  • Med watch 3500A
  • VAERS
3. Aggregate Reports
  • DSUR (Development Safety Update Report)/IND Annual Report/ DASR (Development Annual Safety Report) – Periodic reports required during clinical development
  • PADER (Periodic Adverse Drug Experience Report) – Post marketing periodic drug safety reports required for USFDA as per 21CFR 314.80 and 600.80
  • PBRER (Periodic Benefit Risk Evaluation Report) – ICH E2C(R2) format
  • PSUR (Periodic Safety Update Report) – EMEA format
  • ASR (Annual Safety Report) – Health Canada
  • Integrated Safety Summary (ISS)
  • Addendum to Clinical Outcomes (ACO)
Our Strengths:
  • Methodical Writing Processes
  • Robust quality review
  • Effective benefit risk assessment
  • Compliant and thorough reports
4. Risk Management Activities
  • Risk Management Plans (RMP)
    • Risk minimization measures
    • Post Authorization Safety Studies (PASS)
    • Surveillance Studies
    • Risk Evaluation & Mitigation Strategy (REMS)
    • Proposed REMS strategy
    • Shared REMS documents
5. Signal Management
  • Signal Detection – Qualitative and Quantitative
  • Signal Validation – Compliant with regulatory requirements
  • Fueled by Regulatory Intelligence
  • Thorough medical and QPPV review
6. Label Management
  • Company Core Datasheets (CCDS)
  • Company Core Safety Information (CCSI)
  • Package Insert – PI
  • Summary of Product Characteristics – SmPC
Our Expertise
  • Preparation of Label
  • Updation of Label
  • Label schedule management
7. Pharmacovigilance Master File
  • PSMF – Pharmacovigilance System Master File
  • PVMF – Pharmacovigilance Master File
  • PSSF – Pharmacovigilance Sub-system Master File

e-PSMF software – effective tool to maintain Pharmacovigilance System Master File

Read more

8. Agreements
  • Safety Date Exchange Agreements
  • Legal Representative Agreements
9. Additional Region-specific Services

EMEA

EudraVigilance product management - xEVMPD
European Union-qualified person for pharmacovigilance (QPPV)
In-country pharmacovigilance services, including national contact persons (RP)/QPPVs

India

PVOI – Pharmacovigilance Officer In-charge


4. Pharmacovigilance Support Services

Auditing & Inspection Support
  • Third Party Audit support for your PV system
  • Support during PV inspections
Training
  • Training for sales and marketing staff for safety reporting
  • Training for in-house staff on Good Pharmacovigilance Practices (GVP)
  • Customized training for Literature Management, ICSR processing and Aggregate report writing
  • Online and Onsite options
Consultation
  • Development of pharmacovigilance system
  • Standard Operating Procedure (SOP) development

Representative

Dr. Ripal Gharia
AGM, Pharmacovigilance

Medical Services

Medical Oversight

  • Medical Overview of the clinical trials
  • Training of Study Teams and sites
  • SEC meetings at DCGI
  • On site monitoring
  • Central Monitoring – identifying risks and its mitigation

Medical Writing

  • Feasibility survey reports, disease demographics from India and other territories
  • Protocol
  • Clinical Study Report
  • Informed Consent Documents
  • Subject Diaries
  • Case Report Forms
  • Patient support aids

Regulatory Writing

  • Investigational Medical Product Dossier (IMPD)
  • Investigator Brochure (IB)
  • Clinical & non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities
  • IND, 505(b)(2) and pre-EMEA meeting briefing packages
  • Product Monographs
  • Executive Summary for DCGI submission and SEC presentation
  • Web synopses (Clintrial.gov, EU clinical register, CTRI etc)

Scientific Writing

  • Publication Support
  • Peer-reviewed Publications (from publication planning to journal/ congress submissions)
  • Abstracts, posters (content and layout), slide-sets, conference coverage
  • Medico Marketing Support
  • Flash cards, Detail aids, Leave Behind Leaflets (LBLs), Brand Lexicon
  • Newsletters
  • Drug Brochures/Product Monographs
  • Booklets/Compendiums
  • Patient educational materials
  • CME Slides/Abstracts
  • Training Documents
  • Online Learning/ Training modules
  • Patient Materials