Case Management
Qinecsa provides a complete and compliant operating model in support of clinical and commercial products.
Our experienced team delivers scalable, compliant, and robust pharmacovigilance services to clients.
Sustained, Consistent, and High-Quality Delivery
Engagements are led by pharmacovigilance experts who understand the requirements of regulators, client challenges, and the evolving landscape.
Service Flexibility and Scale
Tailored services to meet clients’ changing needs including flexibility to respond rapidly to project demands and deviations and achieve long-term client loyalty.
Cost Effective Services
Robust infrastructure with standardized processes supported by tools to monitor workflows, to deliver class-leading efficiency for clients.
End-to-End Case Management Services
ICSR Management
- ICSR and SAE case processing.
- Case intake, triage, data entry, and medical review.
- Follow-up and expedited reporting.
- Reconciliation.
Data Migration
- Secure, optimized data transfer.
- Led by experts in pharmacovigilance requirements.
- Flexible services adapt to client needs.
- Cost-effective solutions with high efficiency.
Literature Screening & Review
- Search string design and maintenance.
- Global and local literature screening.
- Medical literature monitoring management.
- Article retrieval and assessment tracking.
Medical Review of ICSRs
- Expert medical review ensures highest drug safety.
- Accurate coding to appropriate MedDRA terms.
- Detailed causality assessment of patient data.
- SOP-driven comments summarize causality conclusions.
Submissions
- Handles electronic and manual ICSR submissions.
- Verifies accuracy and completes expedited reporting.
- Distributes ICSR packages per SDEA obligations.
- Tracks and reports compliance metrics.
Read Our Case Study
Discover how we supported our client’s case processing activities during the COVID pandemic.
Proof in Numbers
Qinecsa is a leading global provider of end-to-end pharmacovigilance solutions. Our team of pharmacovigilance specialists leverage technology solutions to deliver all aspects of global case management for both clinical and post-marketing products.
ICSRs / year
~
0
million
Submission compliance
0
%
Aggregate reports / year
0
Monthly citation reviews
0
Countries
0
Languages
0
Advancing Drug Safety Solutions to the Next Level
We’re working with life science companies to drive progress and continue protecting lives.
