Case Processing & Reporting

PM Clinical provides customers with a complete portfolio of drug safety and risk Mmanagement services for the collection, monitoring, assessment and analysis of drug safety information and the detection of new adverse events. Using our network of resources, we can provide cost efficient data entry and case collection as well as expert quality control consultancy and reporting to the appropriate authorities.

Case Collection & Data Entry

  • Coding
  • Narrative Writing
  • Medical Review
  • Follow-up & Query management
  • Case approval & reporting to Eudravigilance and to any competent authority (EU/non-EU)
  • Report

Periodic Reporting

  • Preparation of PSUR/DSUR according to ICH format with document QC and submission report
  • PSUR/DSUR Calendar development and maintenance
  • Tracking System for KPIs
  • Trend Analysis
  • Preparation of listings and distribution to involved Investigators
  • Preparation and ad hoc safety reporting

LITERATURE SCREENING, SIGNAL DETECTION & RISK MANAGEMENT PLANS

  • Weekly searches of worldwide scientific literature according to key search parameters
  • Performing searches of local scientific journals
  • Full management of ICSR
  • Ad hoc statistical analysis and data mining
  • Preparation and management of Risk Management Plan (RMP)