Individual Case Safety Report (ICSR) Case Processing
Patient safety is one the highest priorities for every pharmaceutical and biotechnology company. Therefore, the pharmacovigilance (PV) team has the crucial responsibility to identify, collect, analyze and process Individual Case Safety Reports (ICSRs) with confidentiality and report to regulatory authorities within the stipulated timelines.
We deliver Case Processing Services leveraging our TOTALVigilance framework that is a cost-effective, flexible, and scalable solution designed to reduce manual effort through digitalization, automation, and real-time oversight. It combines expert knowledge, lean processes, and modern technology to deliver high-quality, compliant services. With adaptable service models and seamless integration into your existing systems and workflows, TOTALVigilance enhances operational efficiency, enables proactive oversight, and maximizes return on investment.
With over 15+ years experience, our PV Team has helped several pharma and medical device companies by high-quality ICSR case processing services by by capturing information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.
- Ensuring accuracy and completeness of information
- Drafting content as per latest regulatory guidelines
- Expert knowledge with schema files and validation procedures
- Timely E-Submission of safety reports in the ICH E2B(R3) format
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
At Techsol, we strive towards delivering high-quality services in preparing Individual Case Safety Reports (ICSRs) for the following categories of medicinal products.
> Branded and Generic Drugs
> Medical Devices and IVDs
> Biologics & Biosimilars
> Vaccines
> Cell and gene therapy products
> Combination products
Digital & Automated Case Processing Services with Realtime & Pro-active Oversight
Case Intake, Receipt & Triage
We have extensive experience in completing intake and receipt by capturing accurate information about all reported AEs, SAEs, SUSARs, ICSRs and other safety records got from the following sources:
- Phase I to Phase III Interventional & Non-interventional clinical trials
- Patient Registries, IITs, Compassionate use programmes
- Spontaneous AE / SAE Reports reported by HCPs and Patients
- Scientific Literature articles and databases (Medline, Embase)
- Health Authority & Legal Sources
> Activities We Perform:
- Daily tracking of all reported incoming cases from various sources in various formats
- Determine case validity and case type (solicited / unsolicited)
- Perform duplicate check and ensure completeness of required case elements
- Send case acknowledgement ID to the sender
Case Processing and Quality Review
Our Safety Associates process each case meticulously by completing the following actvities:
- Capturing reporter information, source, suspected medicinal product and patient information
- Review chronological correctness of AE related patient experiences
- Follow-up with the sender for missing medical information, incorrect data and source documents
Issues that We Resolve Through Quality Review
- Missing adverse events/special situations, co-suspect drugs, medical history, lab data
- Discordant data and medical coding errors
- Identifying incomplete information for narrative preparation, spelling errors and typos
- Missing or inconsistent medical assessment
Medical Review and Narrative Writing
As one of the most critical steps in ICSR case processing, our Medical Reviewers take utmost care to complete the following activities:
- Completing analysis of similar events based reported by the same sender
- Determining case relevance, seriousness and priority based on the potential harm to the patient
- Completing causality assessment and evaluating listedness / expectedness of the reported AE
- Completing Dechallenge and Rechallenge assessments
- Completing medical coding (MedDRA for AEs and WHO-DD for medicinal products)
- Authoring accurate case narratives by referencing patient’s medical history
Distribution & Regulatory Submission
We ensure timely submission of ICSRs to stakeholders and applicable Regulatory bodies by completing the following actvities:
- Sending timely information to Sponsors, Marketing Authorisation Holders for safety management
- Complete EudraVigilance reporting using EV Web and E2B (R3) compliance
- Inform Competent Authorities, Ethics Committees/Institutional Review Boards and Investigators
- Reconciliation with external data collection partners (CROs, affiliates, partners, etc.)
- Tracking acknowledgements on completed submissions for future follow-ups and reference
TOTALVigilance Services
End-to-End Pharmacovigilance Solutions
Latest Relevant Case Studies
December 29, 2022
Establishing an Integrated Global Drug Safety and Signal Management Cloud Solution
December 29, 2022
Argus Safety Cloud Implementation and Validation on Oracle Cloud for HUGEL Pharma
December 29, 2022
Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study
Latest Relevant Insights
August 30, 2021
Literature Screening – Process overview, challenges en-route and the scope for automation
