Drug Safety

Are You Looking for Drug Safety Services from a CRO that Will...

Take a collaborative, cross-functional approach for best results?

Configure databases for reconciliation with your safety database?

Streamline data and reporting so you can focus on other things?

ARG Drug Safety is committed to stakeholders throughout the entire life cycle of a clinical study.

Tell Us About Your Study

What do ARG’s Drug Safety Services Include?

End-to-End Case Processing

Every detail, from expert management of SAEs and AEs to quality control, query resolution, and everything in between.

Customized Data Presentation

Present data based on sponsor preferences and make documents, including MedWatch, CIOMS, E2B, custom or standardized listings and XML documents.

Relieved Burden of Safety Reporting

We alleviate the burden of safety reporting by providing data and generating reports necessary for key regulatory requirements.

Safety Management Plan Generation

Based on global experience, we produced templates for generating custom project safety plans, and support sponsor plan templates.

Safety Database Flexibility

We can configure your study in our safety database (Lifesphere Safety Multivigilance, formerly ARISg) or work in ARGUS or proprietary models.

Metrics Tracking

Case and queries are tracked closely with proprietary application, Safety Metrics Tracker, which also produces reliable metrics for processing activities.

Meet an ARG Drug Safety Specialist

Todd Fisher

Drug Safety Manager

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.

Why Choose ARG for Your Drug Safety Needs?

Customer Service Oriented Success through focus on relationships, sponsor conventions and regular communication.

Strong Connections Above average Drug Safety-to-MM ratio, enabling work with internal and external MM vendors.

No Single Staff Assignments Multiple individuals to a study, giving sponsors more access to ARG support and expertise.

EDC Database Configuration Reduces sponsor reporting burdens, eliminates outside data collection, speeds up reporting time.

Cross-Functional Communications TrialVista platform for cross-functional awareness and responsiveness for site level communications.

Safety Tracking Mechanism Hosts all sponsor needs, forecast and remind of due dates, and produces metrics reporting.

Case Study: Demonstrating Flexibility Towards Unique Sponsor Needs

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.

Want to chat with ARG about your specific drug safety needs?

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