COSMOS eVault is the clinical trial industry’s ultimate companion, consolidating safety reporting, acknowledgments, and compliance monitoring into one powerful, user friendly platform. Say goodbye to scattered documents, manual processes, and anxiety filled compliance checks COSMOS has your back. This purpose built solution harmonizes workflows, automates complex processes, boosts efficiency, and ensures your study is perpetually audit ready. Real Time Safety Record Management With COSMOS eVault, sites and monitors have instant, real time access to essential safety documents, streamlining compliance across multiple sites in various country. This seamless automation drastically reduces administrative burdens, enhances compliance, and ensures that investigators and sponsors are always prepared for inspections without breaking a sweat. Thanks to our integrated platform, once an investigator acknowledges a safety report, it automatically archives into the electronic regulatory binder rBinder, eliminating tedious manual uploads and downloads. Safety Letter Acknowledgement Simplified COSMOS built in automated distribution system sends precise notifications regarding safety events including adverse events, serious adverse events SAEs, and suspected unexpected serious adverse reactions (SUSAR’s) or Vaccine Adverse Event Reporting System (VAERS) directly to the relevant stakeholders. Robust and scalable document management COSMOS eVault is a scalable and customizable SaaS solution designed for secure, compliant document management.
By eliminating overdistribution and duplicate alerts, the platform ensures clarity and easy access to critical safety information, thus keeping your study inspection ready at all times. An embedded quality assurance workflow automatically oversees the lifecycle of each document, saving considerable time and dramatically reducing manual errors. With both short term and long term storage options, COSMOS accelerates your clinical document processing, enhancing workflow efficiency, and maintaining compliance standards without compromising patient safety.
The role based user account access 21 CFR Part 11 compliant electronic signatures COSMOS eVault Your Compliance Guardian. COSMOS eVault simplifies the complexities of document distribution and compliance monitoring, significantly easing site burdens and cutting costs. Reduce unnecessary distribution costs COSMOS sophisticated safety reporting tools eliminate redundant safety letter distribution, ensuring stakeholders receive only relevant, legally compliant documentation. This approach significantly reduces costs, streamlines investigator training, and enhances user experience. This targeted approach prevents unnecessary overdistribution and simplifies access to vital safety information. Regain control stay globally compliant COSMOS Safety reporting solutions empower CROs and sponsors by ensuring tailored safety report distribution aligned with country specific regulations.
Significant cost savings effective safety reporting is traditionally a hidden but substantial cost. Continuous regulatory monitoring ensures that every study site, anywhere in the world, remains inspection ready and compliant. Enhanced Compliance and cost efficiency our robust automated tracking system guarantees timely, secure, and compliant document distribution. COSMOS addresses this directly, streamlining the distribution process to achieve significant budgetary savings. By eliminating manual processes, COSMOS Safety reporting solutions enhance efficiency, compliance, and patient safety keeping your clinical trials running smoothly and securely
End of Study Document Management (EOS)
Optimizing Clinical Data Management Distribution Expenditure COSMOS seamlessly integrates with electronic data capture EDC, IWRS, and eCOA systems, ensuring secure, automated data transfer and precise allocation to study sites. It expertly distributes critical safety documents among investigators, sites, and authorized personnel while providing real time monitoring and acknowledgment reporting.
Key Features of COSMOS eVault Automated and manual file transfers from IWRS, eCOA, or EDC systems Built in QA workflow for meticulous data management automated distribution and acknowledgment tracking timely automated alerts and reminders to study sites. The role based user account access 21 CFR Part 11 compliant electronic signatures COSMOS eVault Your Compliance Guardian. COSMOS eVault simplifies document distribution and compliance monitoring complexities, significantly easing site burdens and cutting costs. Reduce unnecessary distribution costs.