24 September 2019
Pharmacovigilance process gets easier with MainEDC™ by DM 365
The delivery speed of the adverse event notification is a part of the pharmacovigilance process quality. When an adverse event (AE) is registered in the electronic data capture (EDC) system as serious (SAE)
, MainEDC™ by DM 365 functionality triggers sending an immediate notification
about the event to the project team as well as to the persons who are in charge for drug safety and adverse event monitoring.
Therefore, employees of organizations that conduct clinical trials, may promptly start handling, processing, and preparation of relevant documentation for the pharmacovigilance process and its further submission to regulatory authorities, which is required by current regulations. For example, to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) that, starting from September 2019, has launched a renewed database aiming to improve quality, drug safety, and efficacy purposes.
Having fully digital SAE reporting
, MainEDC™ lets shorten terms for the safety data submission and decrease the amount of mistakes.
Moreover, in case an information update or change occurs for the SAE via the eCRF, the team will get a new notification containing up-to-date information.
As a result, MainEDC™ is a perfect instrument that lets companies who conduct clinical trials, have continuous monitoring of safety profile as well as effectively manage pharmacovigilance workflow within the organization in order to increase the responsibility of the organization for safety and quality of pharmaceutical product and timely response whenever necessary.