Secure the Management of Serious Adverse Events

We provide comprehensive management of serious adverse events occurring during clinical trials in compliance with international regulatory requirements.

Nos équipes assurent :

• collection, prioritization, duplicate checks, registration, and data entry of SAEs (Serious Adverse Events)
• medical and regulatory assessment of cases
• causality assessment and expectedness analysis
• identification of SUSARs (Suspected Unexpected Serious Adverse Reactions)
• follow-up management and case completeness
• expedited reporting (Day 7 / Day 15) through EudraVigilance
• notifications to competent authorities and Ethics Committees when required

Strict management of regulatory timelines combined with fully traceable and inspection-ready safety data processes.

Strengthen the Quality and Consistency of Your Safety Data


The quality of safety data relies on reliable data collection and effective communication with investigative sites.


Atessia Vigilances supports:

• pharmacovigilance query management related to eCRF data
• targeted follow-up activities for critical safety data
• communication with investigators and clinical sites
• coordination with CRA, data management, and medical teams
• centralization of safety information

A structured approach designed to improve the quality, consistency, and completeness of safety data.

Produce Robust and Compliant Safety Reports


Sponsors are required to ensure continuous monitoring of the benefit-risk profile of their clinical studies.

Our experts support the preparation of:

• DSURs (Development Safety Update Reports) in compliance with ICH E2F
• Periodic safety reports
• Cumulative pharmacovigilance data analyses
• Signal detection activities benefit-risk evaluations

Robust reports aligned with international standards and ready for submission to health authorities.

Secure Your Projects from the Earliest Development Stages


Clinical trial safety must be integrated from the earliest stages of development.


Atessia Vigilances supports sponsors with:

• drafting and review of protocol safety sections
• contributions to Investigator’s Brochures
• implementation of clinical trial pharmacovigilance procedures
• drafting of SAE Report Forms
• development of Safety Management Plans
• strategic regulatory compliance consulting

Regulatory expertise designed to secure your safety strategy from the design phase of your clinical studies.

Anticipate EMA, ANSM, and International Health Authority Expectations


Clinical pharmacovigilance inspections require robust organization and strong documentation oversight.


Our teams support:

• pharmacovigilance and GCP documentation reviews
• gap assessments and audit readiness activities
• preparation for EMA and ANSM inspections
• remediation of processes and documentation
• preparation of teams and safety systems

A proactive approach designed to sustainably reduce your regulatory risk exposure.

• documented procedures
• full activity traceability
• adapted quality controls
• workflows aligned with regulatory requirements
• safety governance compliant with international standards

• the Clinical Trial Regulation (CTR)
• ICH guidelines
• Good Clinical Practices (GCP)
• EMA and ANSM requirements