Pharmacovigilance System Master File
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.
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 yet 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.