Overview
Patient safety doesn't stop at approval. We support your pharmacovigilance (PV) activities, including adverse event processing, signal detection, and risk management planning (REMS/RMP). We help you maintain a favorable benefit-risk profile throughout the product lifecycle.
Key Features
ICSR case processing
Signal detection and evaluation
REMS design and implementation
Safety database management
Our Process
1
Monitoring
Continuous surveillance of safety data.
2
Assessment
Evaluating signals for clinical significance.
3
Action
Updating labels or implementing risk minimization.
Project Complete & Deliverables Provided
Frequently Asked Questions
An ICSR (Individual Case Safety Report) documents a single adverse event. Reporting timelines depend on seriousness and expectedness: serious and unexpected events must be reported to FDA within 15 calendar days (7 days for fatal/life-threatening). Expected serious events get 15 days. Non-serious events go into periodic reports. We ensure your cases are properly assessed and reported on time.
Why Choose Us
- Patient safety protection
- Regulatory compliance
- Risk mitigation
- License maintenance
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Schedule ConsultationWhat Our Clients Say
"When our safety database flagged a potential cardiac signal, Adelphi's pharmacovigilance team conducted a rapid assessment, determined the signal was confounded, and prepared documentation that satisfied FDA's questions. No label change was needed, and we avoided unnecessary alarm."
Dr. Rachel Green
VP Drug Safety
Biotech Company
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