Aggregate Reports Writing
Ensure high quality, submission-ready safety reports
What we offer
End-to-end management including content collaborations, authoring, review, and timely availability of high-quality submission-ready aggregate reports. We extensively use AI/ML technologies to optimize efforts, ensuring timely availability of safety documents
Who is it for
Heads of drug safety and pharmacovigilance teams
Why it’s important
Plan and track safety reporting in real-time
Ensure timely submissions to HAs
Evaluate risks and benefits accurately
How we deliver
Process
Our aggregate reporting and safety documents authoring team comprises experienced medical writers and healthcare professionals with deep medical knowledge and a good understanding of global safety practices.
We provide end-to-end support from managing global reporting calendars, coordinating with contributors, authoring, medical and quality review for a range of documents. This includes Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, Canadian Annual Summary Reports, and Safety Update Reports.
What makes us different
Interdisciplinary team of medical writers
NLU and NLP technologies contextualized for PV to maximize automation
Understanding of global regulatory/safety practices
Resources
