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Clinical safety & pharmacovigilance

Qinecsa provides a complete and compliant operating model in support of clinical and commercial products.

Our established and proven 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.

Literature Management

Search string design and maintenance.
Global and local literature screening.
Medical literature monitoring management.
Article retrieval and assessment tracking.

Integrated 

Medical and safety writing

Global clinical and post-marketing periodic reports.
Analysis of similar events.
Risk management reports.
Protocol writing and review (safety sections).

Signal evaluation and risk management

Signal management activities.
Risk benefit analysis.
Risk minimization activities.
Drug Safety Monitoring Board representation.

~1 million

ICSRs / year

> 99%

Submission compliance

> 900

Aggregate reports / year

> 80,000

Monthly citation reviews

43

Countries

> 175

Languages