Pharmacovigilance and Medical Monitoring Services
Changing regulatory environments and an increasingly litigious climate have converged. Biopharma innovators must practice exceptional risk management now more than ever.
Our mission is to provide our clients with a division of safety professionals that can comply with global regulations, operate under GVPs and exceed expectations for safety services. By supporting the safety of our subject’s through superior pharmacovigilance expertise and employing experienced professionals, we help support our clients with the successful and safe delivery of a product. Drug safety is integrated into our functional service groups which allows ARG to better serve our clients as a resource from clinical trial development through all phases of a product life-cycle. We utilize known and validated systems as well as innovative processes to obtain and maintain accurate, up-to-date and complete safety information which helps ensure unbiased scientific safety information is available to all stakeholders.
We combine the efforts of physicians and drug safety personnel with innovative systems and operational infrastructure to ensure excellence, transparency and reliability in clinical trial execution. Using the CTMS, TrialVista®, we effectively track and report safety metrics. In addition, we employ the clinical safety case management software ARISg® to manage SAE reporting. ARG is capable of supporting the unique safety needs of products and devices through our technological versatility and knowledge.
As new methodologies emerge and regulations change, it is becoming crucial to increase efficiency while maintaining accuracy to assist in assessing the benefit-risk characteristics of a new therapy. ARG provides leading technology and experienced professionals with the knowledge to apply these solutions to your unique therapies. Our comprehensive understanding of the latest global regulatory environment will ensure the safety of your biologics, compounds, or devices are accurately reported and managed in a way that withstands regulatory scrutiny.