Pharmacovigilance and Safety

Explore how we plan and monitor patient safety throughout your clinical trial and ensure that the proper safety procedures are in place.

Our primary concern at ExperTrials is the patient.

To ensure patient protection as well as data integrity, our staff provides site level safety services through Adverse Events (AE) and Serious Adverse Events (SAE) monitoring and reporting, thorough review of efficacy endpoint data.

Our Safety & Pharmacovigilance services include :

SAEs/SUSARs monitoring

Patient narratives

Annual safety reports and DSURs

Interim safety listings

SAEs reconciliation

Participation in Safety Advisory Board

Clinical trial risk management

Coding (MedDRA, WHO Drug) of adverse event information

The accurate and timely capturing and reporting of SAE is a critical component of a successful trial. Ensuring proper safety reporting procedures to sites, Ethics Committees and competent regulatory authorities is of utmost importance in protecting subjects/patients as well as the integrity of the clinical study results. Therefore, ongoing safety analyses and reporting are vital and require vigilant attention to ensure all SAE are reported in accordance with ICH-GCP and local regulations.

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