Who We Are
Capabilities
___ Case management
- ICSR management
- Literature screening and review
- Data migration
- Medical review of ICSRs
- Submissions
___ Signal & risk management
- Signal detection and management
- Benefit risk management
- RMP
- REMS
- Drug safety physician services
- Regulatory responses
___ Quality and compliance
- PV audit-as-a-service
- QPPV services
- Eudravigilance setup and maintenance
- PSMF setup and maintenance
___ Clinical safety management
- SAE and SUSAR management
- Drug safety and reporting training
- Safety management plan
___ Medical writing
- Aggregate reports
- Protocol review
- Risk management reports
___ MI call center
- 24/7 multilingual call center
- Call intake and follow up
- Design & maintenance of FAQs
___ Local pharmacovigilance
- LPPV and local safety officer
- Local ICSR management
- Local literature monitoring
___ Pharmacovigilance consulting
- PV management consulting
- PV benchmarking
- Regulatory intelligence
- Pharmacovigilance training
___ Healthcare analytics
- Public health surveillance
- Government agency services
- Technology for public health
___ Technology platform
Industry-leading technologies that integrate with the pharmacovigilance landscape to reshape business processes.
Capabilities
Case management
- ICSR management
- Literature screening and review
- Data migration
- Medical review of ICSRs
- Submissions
Signal & risk management
- Signal detection and management
- Benefit risk management
- RMP
- REMS
- Drug safety physician services
- Regulatory responses
Quality and compliance
- PV audit-as-a-service
- QPPV services
- Eudravigilance setup and maintenance
- PSMF setup and maintenance
Clinical safety management
- SAE and SUSAR management
- Drug safety and reporting training
- Safety management plan
Medical writing
- Aggregate reports
- Protocol review
- Risk management reports
MI call center
- 24/7 multilingual call center
- Call intake and follow up
- Design & maintenance of FAQs
Local pharmacovigilance
- LPPV and local safety officer
- Local ICSR management
- Local literature monitoring
Pharmacovigilance consulting
- PV management consulting
- PV benchmarking
- Regulatory intelligence
- Pharmacovigilance training
Healthcare analytics
- Public health surveillance
- Government agency services
- Technology for public health
Technology platform
CVW platform
Reportum platform
Reportum is a unified adverse event platform managing both digital and analogue initial and follow-up reports across global sources and languages.
Advancing drug safety solutions to the next level.
We’re working with life science companies to drive progress and continue protecting lives.
What our clients are saying
"Reflecting on the conversation I am not sure I emphasized thanking you enough for all your/team contributions last year and continuing this year in support of our program. Without your support we would not have been where we are right now"
Head of Safety
US small pharma
"You have become an integral part of our operations. It's often said that people make a business, and in this case, it holds absolutely true, much appreciated!"
CMO
Large pharma
"Your ability to recruit people quickly and adapt on the fly is very much appreciated. I look forward to working with your team."
Clinical Safety Officer
Mid-size Pharma
Latest news
Introducing the Qinecsa PV Insights Network – connecting peers for practical drug safety solutions
Empowering leaders in small pharma and biotech with responsibility for drug safety We are thrilled to announce the launch of the Qinecsa PV Insights Network, an initiative designed specifically for pharmacovigilance (PV) leaders in small pharma and biotech companies...
Join Qinecsa at World Drug Safety Congress US, 18-19 October, Boston
We are thrilled to be heading back to Boston to attend the World Drug Safety Congress US, which brings together 1000+ top leaders and stakeholders in biopharma to discuss the key challenges they are facing in pharmacovigilance and device safety. Our team of...
Join Qinecsa at World Drug Safety Congress Europe, 4-5 October, Amsterdam
Our team is delighted to once again be attending the World Drug Safety Congress Europe, which brings together 1500+ key thought leaders to explore key challenges in pharmacovigilance. From exploring the use of big data and AI in pharmacovigilance, examining...