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

2,500
Periodic safety reports
98
Accuracy rate
99.8
Submission compliance