pharmacovigilance-drug-safety
In Xertz, we understand the significance of safety monitoring and safety reporting practices. Our dedicated high qualified team helps our clients to achieve this by quality programs and processes. Our services will help you to meet the regulatory standards and mitigate risk of compliance issues

We offer a comprehensive and tangible Pharmacovigilance and safety monitoring services from early development support through post-approval initiatives.

Services

  • Adverse event tracking
  • Signal detection and trend analysis
  • Literature reviews and medical narratives
  • Preparation of ICSR, PADER/PAER and PBRER
  • WHODD and MedRA Coding
  • Med Watch/CIOMS form generation
  • Regulatory submissions
  • SAE reconciliation
  • Legacy case transfer
  • Global Expedited Case Reporting
  • Case Narratives
  • Medical Monitoring
  • Risk Management
  • Monthly compliance and status reporting
  • Study documentation review and update, including protocol and IB

Specialties

  • Neurology
  • Oncology
  • Ophthalmology
  • Cardiovascular
  • Dermatology
  • Hematology
  • Infectious Diseases
  • Urology
  • Respiratory
  • Endocrinology, etc

Expertise

  • Best in class technical team.
  • Over 10 years of experience in the areas of Pharmacovigilance/Drug Safety.
  • Security and Safety of data managed as per Regulatory standards (Part 11, HL7, etc).
  • Argus Safety, @ris global, Clintrace, Cares, WHODD, MedDRA, etc., expertise.
  • 6 years of average experienced professionals as trainers, supervisors and Project leads.
  • Coders experienced in working on multiple coding platforms.
  • Handled submissions across the Globe.
  • Our average associate experience is about 3 years
  • Best in class QA with accuracy rates 98%+

Medical Analysis

  • AE and SAE evaluations.
  • MedDRA and WHO-DD Coding.
  • SAE narrative writing and Medical writing.
  • Causality and Labeling Assessments.
  • Physician medical review and signal detection.
  • Literature reviews and summaries.
  • Updating CCDS and other Core documents.

Regulatory Reporting

  • Expedited Reporting (ICSR): Generation of MedWatch3500A/CIOMS I forms
  • Preparation of periodic/aggregate safety reports
  • Prompt notification of potential expedited IND, alert,and suspected unexpected serious adverse reaction(SUSAR) reports via E2B and Paper mail