Case Processing & Reporting

Individual Case Safety Reports (ICSR) in Pharmacovigilance

ICSRs IN PHARMACOVIGILANCE

 

The collection and processing of Individual Case Safety Reports (ICSRs) is a fundamental component of the pharmacovigilance system.

Systems must be in place to ensure the collection and management of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) from interventional clinical trials. Furthermore, following authorisation, all suspected Adverse Drug Reactions (ADRs) must be collected, as well as reports of off-label use, misuse, abuse, medication errors, use during pregnancy, and other ‘special situations’ relevant to safe use of the medicinal product. This information must be collated from all sources including spontaneous reporting from patients and healthcare professionals (HCPs), global literature, contractual partners, post-marketing studies and other solicited data collection activities and company managed social media.

Requirements for ICSRs reporting

 

The National Competent Authorities of countries where products are undergoing clinical trials or are authorised have requirements for expedited reporting of ICSRs meeting certain criteria. Increasingly, reporting of ICSRs is performed electronically via transmission of an eXtensible Markup Language (xml) file following the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ICSR format
[(ICH-E2B(R2) or ICH HL7/ISO-E2B(R3) specification].


Within the European Union (EU), there are centralised requirements for reporting ICSRs from post-authorisation sources on an expedited basis including non-serious ICSRs occurring in the EEA to the EMA’s EudraVigilance database. ICSRs must also be collated for periodic reporting of aggregate reports, signal detection and risk management.

Adverse Events (AEs) Reports

QVigilance can meet all your needs for AEs handling for cases arising from all sources. This includes interventional clinical trials, non-interventional studies and other solicited activities, literature and spontaneous reporting in the post-marketing setting. We offer comprehensive management of cases, from receipt, data entry, coding, medical assessment and follow-up, through reporting to Competent Authorities, Ethics Committees/Institutional Review Boards and Investigators and exchange with partners.

Case Processing & Reporting Services


Case processing is performed by qualified and highly trained pharmacovigilance staff following clear and comprehensive internal procedures and using the best in class technology for safety information management, our validated Argus 8.1 database.

We offer the following case processing and reporting services:

  • Receipt and triage of initial and follow-up cases SAEs, AESIs, SUSARs, ICSRs, regulatory cases
  • Data entry
  • MedDRA coding
  • Narrative production
  • Analysis of Similar Events
  • 100% case quality control (QC)
  • Medical assessment
  • Case closure and locking
  • Generation and distribution of follow-up queries
  • Global expedited case reporting
  • EudraVigilance reporting using EV Web and E2B (R3) compliance
  • Reporting to Competent Authorities, Ethics Committees/Institutional Review Boards and Investigators
  • Reconciliation with external data collection partners (CROs, affiliates, partners, etc.)
NEEN TO OUTSOURCE YOUR ICSRs AND AEs HANDLING?

Get in touch with our Case Reporting specialist team!

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