Pharmacovigilance & Safety Reporting
& Safety Reporting
One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings during pharmacovigilance to all applicable regulatory authorities. Many clinical trials are now being conducted across multiple countries and languages and as a result the safety reporting process has become even more complex.
Trial Interactive's technology can help alleviate the time and language burdens associated with safety reporting. We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace. With the ability to quickly and securely collect, track, translate, and share safety data from investigative sites with internal and external stakeholders, the safety reporting process is radically accelerated.
SAFETY DATABASE HOSTING
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.
Compliant with the EMA’s GVP requirements outlined in Module II.
Contact us to learn more about our pharmacovigilance and safety reporting solutions