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.
Pharmacovigilance operations
Case processing
- ICSR and SAE case processing.
- Case intake, triage, data entry, and medical review.
- Follow-up and expedited reporting.
- Reconciliation.
Medical and safety writing
- Global clinical and post-marketing periodic reports.
- Analysis of similar events.
- Risk management reports.
- Protocol writing and review (safety sections).
Literature Management
- Search string design and maintenance.
- Global and local literature screening.
- Medical literature monitoring management.
- Article retrieval and assessment tracking.
Signal evaluation and risk management
- Signal management activities.
- Risk benefit analysis.
- Risk minimization activities.
- Drug Safety Monitoring Board representation.
ICSRs / year
~
1
million
Submission compliance
0
%
Aggregate reports / year
0
Aggregate reports / year
0
Countries
0
Languages
0