Pharmaco Vigilance Digitalization

Digital & Data Expertise

Support your vigilance activities and digital transformation management

As a recognized expert int he field of Vigilance (pharmacovigilance, materiovigilance, cosmetovigilance; etc.) our squad of pluridisciplinary safety experts work closely together in pre- and post-marketing evironments. We are able to provide operationanl set-up and follow up on saftey activities, at global or local scale. With full traceability and regulatory watch, we provide:

  • Complete safety case reports management (data entry, MedDRA ans WhoDrug coding, Medical Review, Imputability, narratives, submission) in various databases (Argus, ArisG, Safety Easy, …).
  • Expertise in Clinical studies, spontaneous, Litterature and authorities’ cases (Eudravigilance, EMA/MLM).
  • Writing of different type of safety reports like periodic reports (DSUR, PSUR, PBRER), authorities’ submission (HAS, EMA) and Risk Management Plan.
  • Writing of safety part of protocol, product information, and product overview.
  • Medical literature watch with screening (data bases, MLM and scientific journals), medical review, assessment, and case processing.
  • Signal detection by submitting queries in vigilance and authorities’ databases, validate the signal, and then analyze it.
  • Quality control of all safety activities (quality check of cases, double check of narratives, …)
  • Accompagnement à la préparation et la réalisation d’audit et inspection, gestion des déviations et mise en place des CAPAs.
  • Medical information at 1, 2 and 3 levels, via our call center (24/7) and our teams. We manage declarant relationship (patient and health care practitioners).

We support Life Sciences industries in the management of vigilance activites for several years. Notre approche multiclient nous permet d’appréhender les contraintes et variations de charges liées à la vie du médicament. We advise our parteners and customers in their strategic decisions and implementation.

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