Business & Decision Life Sciences are the trusted partner as vigilance expert in Pharmacovigilance, Materiovigilance, Cosmetovigilance and Nutrivigilance. Our team of pluridisciplinary safety experts works closely together in the pre- and post marketing environment to provide operational set-up and follow up of safety activities, at a global or local scale with full traceability and a regulatory overview.
- Complete safety case report management (data entry, MedDRA and WhoDrug coding, Medical Review, narratives & submission) in various databases (Argus, ArisG, Safety Easy, …).
- Expertise in Clinical studies, literature and authorities’ cases (Eudravigilance, EMA/MLM).
- Safety reports writing like periodic reports (DSUR, PSUR, PBRER), authorities’ submission (HAS, EMA) and Risk Management Plans.
- Safety part of protocols, product information, and product overviews Writing.
- Medical literature review with screening (data bases, MLM and scientific journals), assessment, and case processing.
- Signal detection by submitting queries in vigilance and authorities’ databases, validating the signal, and then analyzing it.
- Quality control of all safety activities (quality check of cases, double check of narratives, …)
- Audit support from preparation to realization. Management of deviations and set-up of CAPAs.
- Medical information at 1, 2 and 3 levels, via our call center (H24/7D) and our teams. We manage declarant relationship (patient and health care practitioners).
Why choose us?
We have been supporting Life Sciences industries in the management of vigilance activities for several years already.
Our multiclient approach allows us to anticipate constraints & variations of charges linked to the life cycle of the drug. We advise our partners and customers in their strategic decisions and implementation.