Asgenia is your strategic partner in Pharmacovigilance for Clinical Trials. Safety, Compliance and Scientific Rigour for your Clinical Studies
In the increasingly complex and regulated landscape of clinical studies (Phase I-IV and Non-Profit), safety management is not just a regulatory obligation, but the pillar on which the success of the entire trial rests.
Entrusting Clinical Pharmacovigilance to a specialised partner means ensuring maximum protection for patients and data integrity, while optimising development time and costs. Asgenia acts as the right hand of your research team, offering tailor-made solutions and outstanding expertise.
End-to-End Clinical Pharmacovigilance Solutions
We provide flexible, comprehensive management of all the safety activities required during the conduct of a clinical trial:
Collection, triage, medical assessment, data entry and coding (MedDRA) of serious adverse events.
Expedited submission and reporting to Competent Authorities (via EudraVigilance/dedicated Gateways), Ethics Committees and Investigators, in full compliance with legal deadlines.
In-depth scientific review of cases by dedicated physicians and drafting of accurate clinical narratives.
Drafting, review and submission of Development Safety Update Reports (DSURs).
A round-the-clock on-call medical service for the prompt handling of medical emergencies and unblinding criteria.
Operational and scientific-regulatory management for Data Safety Monitoring Boards (DSMB) or Independent Data Monitoring Committees (IDMC).
Managing clinical safety in-house requires massive resources, constant updates and costly technological infrastructure. That is why our clients choose to outsource this crucial process to us:
The regulatory framework (from ICH-GCP guidelines to EMA and FDA regulations) is constantly evolving. Our team is continuously trained and kept up to date on the latest legislative provisions, protecting you from non-compliance, approval delays or penalties during inspections.
We don't just enter data into a database. Our strength lies in our ability to fully understand the science behind the molecule or device under study. Thanks to a team of expert Medical Reviewers, we provide a critical analysis of the investigational drug's tolerability profile.
Whether you are running a small Phase I bioanalytical study or a multicentre international Phase III trial, our structure adapts to your actual needs. We reduce your fixed costs by turning them into variable costs linked to the actual data volume of the study.
We use state-of-the-art safety databases, fully compliant with 21 CFR Part 11 and GAMP 5. This ensures maximum cybersecurity, data traceability (Audit Trail) and seamless integration with eCRF systems.
Every one of our processes is governed by strict Standard Operating Procedures (SOPs) and subject to continuous internal audits. We guarantee stringent performance metrics (KPIs) to ensure that every SUSAR report or DSUR is submitted with zero days of delay.
Unlocking the potential of your research, while protecting patients' lives.
Choosing Asgenia means choosing the peace of mind of a safe, compliant clinical trial with no surprises.
