Advancing Drug Safety with Innovative Digital Pharmacovigilance Solutions
Qinecsa are redefining drug safety with our technology-enabled, end-to-end pharmacovigilance services, designed to help pharmaceutical companies stay ahead in an evolving regulatory landscape.
Our Industry-Leading Drug Safety Technology Platforms
Best-in-class technology that integrate with the pharmacovigilance landscape to reshape business processes.
Reportum
Our automated case intake and follow up platform, Reportum, provides a centralized solution for multi-lingual data capture across all intake sources to increase efficiencies and standardize safety data intake and management.
HaloPV
Revolutionary platform for managing all drug safety processes comprehensively, from ICSR, submissions, Aggregates, signal, risk management, PSMF, and beyond.
Vigilance Workbench (QVW)
Our signal detection & management platform, Vigilance Workbench (QVW), spans the full spectrum of the signal management process to ensure no signals are missed and important signals are prioritized.
Our Comprehensive Pharmacovigilance Services
Supported by the highest caliber of medical and scientific staff to generate rapidly vital safety insights.
Case Management
Provides ICSR management, literature screening and review, data migration, medical review of ICSRs, and submissions.
Signal & Risk Management
Supports signal detection and management, benefit risk management (RMP, REMS), drug safety physician services, and regulatory responses.
Quality and Compliance
Delivers PV audit-as-a-service, QPPV services, Eudravigilance setup and maintenance, and PSMF setup and maintenance.
Clinical Safety Management
Manages SAE and SUSAR workflows, delivers drug safety and reporting training, and supports safety management plan development.
Medical Writing
Produces aggregate reports, supports protocol review, and delivers risk management reports.
Pharmacovigilance Consulting
Offers PV management consulting, PV benchmarking, regulatory intelligence, and pharmacovigilance training.
Local Pharmacovigilance
Provides LPPV and local safety officer support, local ICSR management, and local literature monitoring.
Medical Device Vigilance
Delivers complete materiovigilance and post-marketing surveillance support, including US 21 CFR Part 803 and EU MDR 2017/745 requirements.
Healthcare Analytics
Advances the science of signal detection, supports public health and regulatory agencies, and delivers complex customized analyses.
Medical Information Call Center
Provides a 24/7 multilingual call center for intake and follow up, including the design and maintenance of FAQs.
Quantitative Signal Detection as a Service
Turn pharmacovigilance data into actionable insights with proven statistical methods and expert-guided signal detection.
All Services
In this era of rapid evolution, Qinecsa’s unrivalled pharmacovigilance service offerings empower companies to adapt, ensure patient safety, and successfully support their invaluable product portfolios.
Who We Are
We are trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions.
From end-to-end pharmacovigilance and clinical safety support to signal and risk management, medical information, and advanced analytics, we help organizations build safer, more resilient operating models that perform under real-world pressure.
- Global safety specialists supporting pharma, biotech, med device, and public health organizations
- Technology-enabled services that improve consistency, control, and efficiency
- Deep scientific expertise across case, signal, risk, quality, and compliance workflows
- Practical, partnership-led support designed to scale with your needs
Trusted support, built for real-world drug safety
At Qinecsa, we combine scientific expertise and technology to support the way safety functions operate in practice, not just on paper.
We partner with your team to strengthen oversight, improve consistency, and help you stay inspection-ready as your portfolio, partners, and reporting demands evolve. Whether you need operational support, strategic guidance, or specialist insight, we help you move forward with greater control and confidence.
Talk to a PV Specialist
Innovation Spotlight
We have created industry-leading, end-to-end solutions for capturing, managing, and evaluating drug safety data more efficiently and accurately.
End-to-End Case Management
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.
Next Generation Literature Management
Our innovative literature screening merges expertise with automation for increased productivity and compliance. Designed to expedite compliance while enhancing productivity, it features industry experts and cutting-edge AI software.
Working with Reportum’s digital-first capabilities from the very start of our first product launch has ensured that we receive high quality adverse event and product quality data more efficiently—direct from sources such as consumers, healthcare professionals, and employees. The platform has enabled us to streamline our case intake process while delivering a strong ROI.
Additionally, Reportum’s scalability makes onboarding new partners, such as specialty pharmacies, seamless, keeping us agile and prepared for future portfolio and case volume
growth.
Christy Rathjens, MBA, RPhT
Sr. Director, Global Patient Safety, Aurinia Pharmaceuticals Inc.
Since partnering with Qinecsa in 2009, our joint team collaboration has steadily evolved into a strong and reliable working relationship. Their flexibility, proactive approach, and openness in discussions have been key to a smooth and dependable collaboration.
Head of Global Patient Safety
Gedeon Richter
Advancing Drug Safety Solutions to the Next Level
We partner with life science companies to strengthen safety, drive progress and help protect patients worldwide.