Get notifications of submissions of SAEs and SUSARs in real time, and enable instant translation submission for forms coming from international sites.
Decrease in CEC adjudication time
Decrease in endpoint and package processing time by CRO
Decrease in translation turnaround time
Decrease in shipping costs
Collect and store cases received (ADRs, medical information, product complaints, non-case calls)
in a 21 CFR Part 11 compliant, validated, web-based global database.
Turn your hard copy PSMF documentation into a centrally stored, real-time accessible online file, available to regulatory inspectors, global teams, and approved partners.
Comply with the EMA’s GVP requirements outlined in Module II.