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24 September 2019 Articles

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. Once an Investigator has registered an adverse event (AE) in the electronic data capture (EDC) system as serious (SAE), MainEDC immediately alerts the project team about the event as well as the persons who are in charge of drug safety. The alert comprises a PDF copy of the completed eCRF page.

Therefore, employees of organizations that conduct clinical trials, can 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. The update aimed to improve quality, drug safety, and efficacy purposes. 

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Supporting fully digital SAE reporting, MainEDC lets shorten terms for the safety data submission and decrease the amount of mistakes. Moreover, in case an SAE related information update has occurred in the eCRF, the team will get a new notification containing up-to-date information. 

Having said the above, MainEDC is a perfect tool that allows companies who conduct clinical trials, have continuous monitoring of safety profile as well as effectively manage pharmacovigilance workflow within the organization. This enables the increased responsibility of the organization for the safety and quality of pharmaceutical products and timely response whenever necessary.