Vigilazierta is a groundbreaking pharmacovigilance database, fruit of collaboration between AZIERTA, leader in science-project management and consultancy, and GMV, a leading company in healthcare software development and technology.
Vigilazierta is software for drug and health-product safety management and support during clinical trials. It is based on E2B and the MedDRA standards, enabling users to classify create, review, maintain and submit pharmacovigilance data in a swift and secure way to competent authorities and other third parties.
Vigilazierta offers many different options for submitting reports, either through a gateway or by exporting/importing XML files or emailing them as attachments.
Vigilazierta facilitates the creation of CIOMS and Medwatch forms, lists for periodic safety reports, signal analyses and also includes a case review scale.
Vigilazierta is born as a complete, trailblazing database complying with all current recommendations, directives and regulations on the online notification of adverse reactions under the GAMP specifications.
Vigilazierta can be used in many different computing environments so it offers the added value of great flexibility in its use and also helps to cut client costs.