Capturing signals from varied sources to assure safety of the product to regulatory authorities

Data collected from the clinical trials may be limited to assure the safe use of the product after the product is authorized. The sponsors are required to collect signals from spontaneous reports, clinical studies, and scientific literatures.

Signal management process includes the following activities:

• Signal detection
• Signal validation
• Signal confirmation
• Signal analysis and prioritization
• Signal assessment and recommendation for action

The processes adopted by the APCER Signal Management team involves in-depth review and medical assessment of safety data. This is undertaken by a dedicated team of healthcare professionals, including physicians, under close supervision and oversight of experts.

We follow robust signal management processes to meet global and local regulatory requirements. We support sponsors in wide-ranging activities covering signal detection from multiple sources, signal validation, and signal analysis and prioritization.

We also offer the following specialized services:

• Integration of legacy data and gap analysis
• Standalone signal notification as applicable
• Submission of validated signals through various channels as applicable
• Handling of regulatory recommendations
• Preparing responses for requests/queries received from the health authorities
• Creation and review of signal management procedures
• Workshop/Training on signal management process
• Process set-up support on MAH oversight/implementation process