Our Expertise
Timely reporting and management of serious adverse events (SAEs) in clinical trials is vital to patient safety, compliance and regulatory requirements. Your AMS team will provide medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out. Your AMS experts will ensure the clinical integrity of the trial subjects and provide safety accountability across the duration of the study, while acting as expert points of reference for both investigative sites and study team members.
Pharmacovigilance
AMS provides clinical trial pharmacovigilance services for drug safety monitoring and management of SAEs, Adverse Drug Reactions (ADRs), ADEs and other patient safety events as per clinical trial protocols. Our Clinical Trial Safety Associates work closely with our Clinical Data Managers to ensure timely processing and reporting of such events reported by clinical trial personnel, to follow up on resolution of data discrepancies, and to achieve timely and quality final reports of the event information.
Some of our surveillance services include:
Development and maintenance of a study-specific Safety Management Plan
Building sponsor specific, compound, and study level safety database
SAE notification via system alert emails and documentation
Case assessment, processing, and management
Electronic generation of regulatory reports (e.g., MedWatch/CIOMS forms, E2B files)
Electronic generation of patient narratives
Expedited reporting to regulatory agencies and investigators (for reporting to IRB/IEC)
Simple and streamlined annual safety updates for compounds/programs and individual studies
Performing integrated data analyses and generation of Integrated Summary of Safety (ISS) reports
Performing analysis of safety database, trending and signal detection for ongoing clinical trials and for post-marketing drug safety surveillance activities
Medical Monitoring
Our experienced physicians provide medical oversight and review for clinical studies. Their roles and responsibilities can be tailored for each client.
Such responsibilities are reviewed below:
24/7 availability to clinical sites for emergency safety issues
Site interactions for clarification or queries on protocol specifics or study conduct, such as inclusion/exclusion queries, concomitant medications, or adverse event management or reporting
Review of safety data on an ongoing basis to identify potential risks or safety signals
Review of safety listings to ensure accurate serious adverse event reporting
Review of SAEs with provision of causality assessments and regulatory recommendations
Coding reviews to ensure accurate and consistent data for the study and program
Participation in Data Safety Monitoring Boards or Safety Review Committees
Medical review of final study reports, DSURs, PSURs, RMPs, and dRMPs
Individual case report and aggregate safety reviews
We specialize in a variety of services and solutions.
