Who we are
We are trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies to the right safety solutions.
Our Services
Supported by the highest caliber of medical and scientific staff to generate rapidly vital safety insights.
___ 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
___ Pharmacovigilance consulting
- PV management consulting
- PV benchmarking
- Regulatory intelligence
- Pharmacovigilance training
___ Local pharmacovigilance
- LPPV and local safety officer
- Local ICSR management
- Local literature monitoring
___ MI Call center
- 24/7 multilingual call center
- Call intake and follow up
- Design & maintenance of FAQs
___ Healthcare analytics
- Progress the science of signal detection
- Support public health & regulatory agencies
- Perform complex customized analyses
Our Technology
Industry-leading technologies that integrate with the pharmacovigilance landscape to reshape business processes.
Reportum platform
Reportum is a unified adverse event platform managing both digital and analogue initial and follow-up reports across global sources and languages.
CVW platform
The Commonwealth Vigilance Workbench (CVW) signal detection platform spans the full spectrum of the signal management process to ensure all potential signals are tracked with clear prioritization.
Find out more
Advancing drug safety solutions to the next level.
We’re working with life science companies to drive progress and continue protecting lives.
