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 :
Annual safety reports and DSURs
Interim safety listings
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.