Data integrity in aggregate reporting: Ensuring accuracy and reliability
Aggregate reports provide periodic review of safety data in a global and cumulative way instead of looking at individual cases. While the concept is simple, the process can become complex to manage. To understand the benefit–risk profile of a product, the process requires the collection and assessment of safety data as well as handling the necessary aggregate reports across a product’s lifecycle in various markets.
The Med Communications Pharmacovigilance (PV) team provides complete end-to-end management of all aggregate report types, including:
- Assisting clients with templates
- Handling data retrieval/requests
- Managing the review process
- Managing timelines to facilitate the contributions of each stakeholder
- Assuring compliance with submission deadlines
- Analyzing the data
- Drafting the content of the required reports by retrieving the necessary data and listings from the safety database
Our PV team will use their expertise and all available tools to assist clients with forecasting the reports required for each market and product and with planning the appropriate reporting periods, data lock points, and submission dates for each regulatory authority. Contact us to learn how we can meet your aggregate reporting needs: 877-477-0977 or https://medcommunications.com/contact-us.
