ARG Drug Safety is committed to stakeholders throughout the entire life cycle of a clinical study.Tell Us About Your Study
Every detail, from expert management of SAEs and AEs to quality control, query resolution, and everything in between.
Present data based on sponsor preferences and make documents, including MedWatch, CIOMS, E2B, custom or standardized listings and XML documents.
We alleviate the burden of safety reporting by providing data and generating reports necessary for key regulatory requirements.
Based on global experience, we produced templates for generating custom project safety plans, and support sponsor plan templates.
We can configure your study in our safety database (Lifesphere Safety Multivigilance, formerly ARISg) or work in ARGUS or proprietary models.
Case and queries are tracked closely with proprietary application, Safety Metrics Tracker, which also produces reliable metrics for processing activities.
Our processes ensure 100% Sponsor awareness of all things safety related during a study. From developing custom reporting forms and plans to maintaining oversight of all adverse event reporting and documentation, we are your eyes and ears for Safety surveillance.
One of our sponsors requested ARG to provide data for the Data Safety Monitoring Committee for two trials.
The sponsor wanted to see the data in an innovative way that portrayed the sequence of events for subjects, rather than standard listings and SAE narratives.
We fulfilled these needs by transforming a complex matrix of SAEs experienced by subjects during the trial, into a series of concise, truncated summaries.
Through the diligent work of our Drug Safety team, we produced chronologically referenced, sequenced, and comprehensive “SAE stories.”
ARG went beyond simply producing data listings or individual SAE narratives by providing a much more profound story for each subject.
The consumable format of the summaries enabled the Data Safety Monitoring Committee to better understand and assess the progression of events experienced by the trial subjects.