Pharmacovigilance

Handling SAE/AE:

• Collection, collation and compilation of AE/SAE reports from the marketplace
• Adverse event (AE) and serious adverse event (SAE) narrative writing /data entry, logging, tracking, coding, assessment, case processing and follow-up
• Generation of safety data reports (SDRs)

Data Management:

• Establish database systems and standard operating procedures (SOPs) for each product to be monitored.
• Adverse Event, Serious Adverse Event (SAE) data collection and analysis
• Protocol design and implementation of post-authorization safety studies.
• MedDRA Coding

Medical Analysis/Review

• Clinical assessment reports of completed studies.
• Adverse event (AE) and serious adverse event (SAE) evaluations
• Analyze data to identify early signals proactively identifying safety issues.
• Search and evaluation of scientific literature (reports of published studies and studies on the product safety)

Regulatory Reporting

• Preparing Annual Safety Reports (ASRs) & Periodic Safety Update Reports (PSURs)
• Electronic Safety Reporting according to ICH E2B

For further information contact: info@adicro.com