Your partner in patient safety at every stage in the product lifecycle
Accelagen provides high quality clinical safety and pharmacoviligence services that span every phase of a product’s life.
From the development stage through to post-market monitoring, we take a patient-first approach that emphasises adverse reaction monitoring and reporting. Our experienced team devises meaningful insights from safety data, informing investigational understanding as well as a product’s long-term safety profile.
- Individual case safety report (ICSR) collection
- Medical review of ICSR and signal detection
- Risk Management Plan and Australian Specific Annex preparation
- Ongoing literature review and monitoring
- Development of safety data exchange agreement
How we work
Shaping early adverse event knowledge
Our robust safety data management and regular reporting delivers detailed adverse event knowledge throughout the product development phase and in preparation for regulatory submissions.
Detailed post-market monitoring and pharmacovigilance
We put in place effective processes to identify, collect and evaluate safety data post-market, expertly informing any changes to your products adverse event profile.
Safety and pharmacovigilance
case studies
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