Manage ICSR operations with confidence
Cencora provides end-to-end individual case safety report (ICSR) management across intake, triage, data entry, quality review, medical review, reporting, and archiving. Our teams support global and local case processing with structured workflows and operational governance.
You gain scalable support for post-marketing, clinical trial, literature, solicited, and non-interventional study cases, with technology-enabled processes designed to improve consistency, throughput, and compliance.
You gain scalable support for post-marketing, clinical trial, literature, solicited, and non-interventional study cases, with technology-enabled processes designed to improve consistency, throughput, and compliance.
Address ICSR workload pressures early
ICSR operations must keep pace with rising case volumes, varied intake sources, and strict reporting timelines. Cencora helps you reduce delivery risk with structured workflows, oversight, and trained safety teams.
Volume variability
Manage changing case volumes with scalable teams, phased ramp-up, and governance designed to maintain throughput, quality, and on-time submissions.
Manual process risk
Reduce errors, rework, and visibility gaps by replacing spreadsheet-dependent activities with structured, system-driven case processing workflows.
Reporting complexity
Handle global and local reporting requirements, partner exchanges, and reconciliations with coordinated tracking and compliance-focused oversight.
Comprehensive ICSR management support
You receive end-to-end ICSR management support across adverse drug reaction collection, triage, book-in, data entry, quality review, medical review, reporting, and archiving.
Cencora also supports contact center interfaces, medical information handoffs, product quality complaint intake, reconciliation activities, and workflow monitoring to help keep safety operations complete and compliant.
Cencora also supports contact center interfaces, medical information handoffs, product quality complaint intake, reconciliation activities, and workflow monitoring to help keep safety operations complete and compliant.
What we offer
Case intake and exchange
Collection, triage, and book-in from every applicable source, including partner and vendor case exchange, for complete, timely case capture.
Case processing and follow-up
Data entry, coding, narrative writing, and follow-up activities for post-marketing, clinical, literature, solicited, and special situation reports.
Medical review
Clinical assessment, causality evaluation, and company comment support from qualified medical professionals aligned to defined procedures.
Quality and governance
Independent review, completeness checks, error trending, and KPI reporting under defined governance to improve accuracy and reduce rework.
Submission and reconciliation
Reportability checks, submission tracking, negative acknowledgement resolution, and reconciliation with partners and safety databases to keep reporting on schedule.
Flexible engagement models
Full outsourcing, functional service provider (FSP), hybrid or co-sourcing, and project or surge support for global, regional, and local case processing.
Why choose Cencora for ICSR management
Built-in regulatory compliance
Global and local reporting rules are applied at every step, so cases reach authorities and partners complete and on time.
Inspection-ready case quality
Independent checks, error trending, and documented governance give inspectors a clear audit trail for every case you report.
Technology-enabled, scalable delivery
Validated workflow tools and automations that help global teams scale with case volumes, keeping throughput and timelines steady through ramp-ups and surges.
Expert insight
For busy safety teams, minimizing the manual tracking component of managing local PV activities can significantly improve data quality and consistency which, in turn, enhances overall audit-readiness and compliance.
— Iain Barnden
How automation increases efficiency and accuracy of local PV monitoring and KPI tracking
Related solutions
Clinical trial pharmacovigilance activities
Manage clinical trial safety activities with expert support for adverse event processing, safety writing, and compliant submissions across global studies.
Safety monitoring and signal detection
Strengthen signal detection and safety monitoring with tailored review, validation, assessment, and action support across your pharmacovigilance activities.
PharmaLex is now Cencora
ICSR management is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about ICSR management?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.