What are ICSR Case Processing Services?
Our services manage the full lifecycle of ICSRs, including intake, triage, MedDRA coding, narrative drafting, seriousness assessment, and E2B R2/R3 submissions, ensuring global pharmacovigilance compliance.
ICSR Case Processing for Global Compliance
Efficient and Precise Pharmacovigilance Solutions
At Indivirtus Healthcare Services Pvt. Ltd., our ICSR Case Processing service provides full lifecycle management of Individual Case Safety Reports for pharmaceutical and biotech companies. From intake to E2B R2/R3 submissions, we ensure regulatory compliance and signal detection readiness with expert triage, MedDRA coding, and validated systems.
Why is it Critical?
Efficient ICSR processing ensures patient safety, regulatory compliance, and accurate adverse event reporting, supporting signal detection and audit readiness.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led ICSR solutions, providing precise, compliant, and traceable case processing for global safety monitoring.
Our Expert ICSR Processing Approach
At Indivirtus Healthcare Services, our ICSR Case Processing services are led by certified pharmacovigilance specialists with global compliance expertise. We handle intake, triage, MedDRA coding, narrative drafting, seriousness assessment, and E2B R2/R3 submissions using industry-standard safety databases.
Our structured workflows ensure traceable and compliant case management, with follow-up actions and source reconciliation to support signal detection and regulatory submissions, aligned with ICH E2B, GVP Module VI, and FDA/EMA standards.
ICSR Case Processing Deliverables
Processed ICSRs (MedWatch, CIOMS, e2B XML): Fully compliant case reports.
MedDRA-Coded Adverse Events: Standardized coding for accuracy.
Case Narratives and Seriousness Justification: Detailed and compliant documentation.
Follow-Up Action Logs: Records of case follow-up activities.
Reconciliation Reports with Safety Database and Source Systems: Ensured data integrity.
Regulatory Compliance & Global Standards
Our ICSR Case Processing services align with stringent global pharmacovigilance standards, ensuring your documentation is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance safety and regulatory confidence.
- ICH E2B(R2/R3): Guidelines for electronic submission of safety reports.
- GVP Module VI: European standards for adverse event reporting.
- FDA 21 CFR Part 314.80: U.S. regulations for post-marketing safety reporting.
- EMA Volume 9A: European guidelines for pharmacovigilance processes.
Applications & Use Cases
Our ICSR Case Processing services are essential for pharmaceutical and biotech companies managing global pharmacovigilance requirements. Ideal for spontaneous and solicited case workflows, signal detection, and regulatory submissions, our solutions support patient safety. Key use cases include processing ICSRs for new drug products, supporting post-market surveillance, and ensuring compliance for global markets.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical and biotech companies, delivering expert-led ICSR processing solutions backed by certified pharmacovigilance specialists with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, efficient, and traceable ICSR management, driving regulatory success and patient safety.
Frequently Asked Questions
Frequently Asked Questions
What case types do you support in ICSR processing?
We handle both spontaneous and solicited case types, including clinical trial cases, literature reports, patient support program cases, and post-marketing spontaneous reports.
Do you support MedDRA version upgrades and dictionary management?
Yes, we support MedDRA version upgrades and use validated tools for dictionary version control and auto-recode functions as per MedDRA MSSO updates.
Can you process and submit E2B (R3) files through our safety database?
Absolutely. We integrate with safety systems like Argus, ArisG, and Veeva Vault to process and submit E2B files, including gateway communication when access is provided.
How is seriousness and causality assessed?
Our medically qualified team assesses seriousness and causality based on client SOPs, reference safety information (RSI), and global regulatory expectations.
How do you ensure case reconciliation accuracy?
We perform regular reconciliation between source systems (e.g., medical information, clinical, PV database) to ensure no case is missed or duplicated, with full traceability logs.
What do ICSR Case Processing services include?
Our services include intake, triage, MedDRA coding, narrative drafting, seriousness assessment, E2B R2/R3 submissions, follow-up, and reconciliation, ensuring PV compliance.
Who benefits from ICSR Case Processing services?
Pharmaceutical and biotech companies managing spontaneous or solicited ICSRs for regulatory compliance and signal detection benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with ICH E2B(R2/R3), GVP Module VI, FDA 21 CFR Part 314.80, and EMA Volume 9A, ensuring global pharmacovigilance compliance.
What deliverables are provided with the service?
Clients receive processed ICSRs, MedDRA-coded events, case narratives, seriousness justifications, follow-up logs, and reconciliation reports.
Can the ICSR processing services be customized for our needs?
Yes, our services are tailored to your specific drug products, PV workflows, and regulatory requirements, ensuring compliant and efficient processing.
How do the services support signal detection?
We provide accurate MedDRA coding, seriousness assessments, and reconciliation to ensure ICSRs are ready for signal detection and regulatory analysis.