Adverse Event (AE) Processing and Reporting
Adverse event reports are accurately documented, assessed, coded, and evaluated by our medical and professional staff. Individual case reports and periodic adverse drug experience reports are prepared and submitted to you and the FDA, and we retain all records in accordance with regulatory requirements.
- AEs are received from patients, consumers, and healthcare providers (HCP)
- Cases are managed through a 21 CFR 11 compliant database
- Follow-up is conducted as necessary with patient or healthcare provider
- Regulatory assessment for expectedness and seriousness is conducted by experienced professionals
- A physician evaluates all cases, including MedDRA coding
- Individual cases are submitted to FDA
Literature Surveillance
- Searches of the global medical and scientific literature are conducted
- Adverse Event cases identified in literature are processed and submitted
- Clients can assist in developing search strategy and profile
Aggregate Reports
- Periodic Adverse Drug Experience Reports (PADER) are written and prepared for submission
- All PADERs are reviewed by a physician with drug safety experience
- PADERs are submitted on behalf of clients
