Argint has a very strong medical team in-house consisting of 17 MDs with various specialisations. Our physicians provide medical support to the project team and can assume the role of reactive medical monitor on specific studies.
Argint's chosen partner for pharmacovigilance services is ProductLife UK Ltd. Argint has a proven track record of collaboration with ProductLife over many years and we subcontract their PCV services for clients as needed.
- Maintenance of the product safety database (fully validated safety database system which is E2B and 21 CFR Part 11 compliant)
- Individual Case Safety Reports processing for Serious Adverse Events (SAEs)
- Medical Monitoring and Medical assessments of SAEs
- Full Serious Adverse Event case management (SAE processing, SUSAR submissions)
- Developmental Safety Update Reports (DSURs)
- EudraVigilance registration and maintenance
- Un-blinding and global regulatory reporting
- ICSRs, monthly line-listings, annual safety reports and periodic safety update reports
The Medical Monitoring Plan provides a comprehensive review of procedures and practices to be conducted by the Medical Team during the course of the study. Medical monitoring ensures that medical data generated from the trial are valid and reliable, and the early recognition, identification and reporting of issues impacting on patients' health and well-being are maintained for the duration of the trial.
The role of medical monitor is divided into two distinct functions: proactive and reactive medical monitoring.
Argint's own medical personnel assume the 24/7 reactive medical monitoring function. Argint assigns experienced physicians to the study team and calls from investigators relating to the protocol, procedures, eligibility or safety issues are directed to the assigned Argint study physicians. Received calls are directed to the physicians assigned to the study who are both familiar with the study and the indication. Questions related to predefined issues are escalated to the client as agreed and as defined in the Medical Monitoring Plan.
ProductLife UK Ltd., Argint's chosen partner for medical monitoring support, provide the proactive medical monitoring service which includes:
- Review the eligibility requirements and any violations
- Review of safety signals
- Review of Frequently Asked Questions (FAQs)
- Monthly review of all AE's in a study and perform on-going safety trend analysis and signal detection
- Monthly review of all SAE’s in a study and perform on-going safety trend analysis and signal detection
- Review laboratory listings and other trial data to identify safety risks ensuring compliance with actions recommended in the protocol