REALTIME EREG/EISF – for sponsors & cros
Centralize Regulatory Oversight Across Every Site
Simplify regulatory management across sites and studies with one connected system that gives your team greater visibility, keeps documentation organized, and helps maintain inspection readiness.
Drive site adoption
Give sites an easier way to manage regulatory work with flexible workflows, training, and support.
Simplify site workflows
Help sites organize documents, automate routine tasks, and keep regulatory files inspection-ready.
Strengthen site oversight
Monitor site activity and regulatory documentation remotely with greater visibility across studies.
Streamline Collaboration
Connect sponsors, CROs, sites, and investigators through secure, centralized workflows.
Access self-service monitoring and visibility with effective site collaboration.
Remote monitoring, decentralized trials, and remote ISF review as an option for any trial.
Activate sites to support their investigators anytime, anywhere, for inspection-ready regulatory and site files.
Remotely manage all stakeholders and documentation throughout the clinical trial life-cycle and clinical trial portfolio.
BUILT FOR SITE ADOPTION
Make eISF easier for sites to use.
Rapid start-up & site adoption, without the need for additional study build. Create any type of study and ISF with documentation and automation templates. Â
Easily transition eISF control to any site, anywhere, with built-in training, validation, and support, and an option to function as a TMF or Site Portal for standardization.Â
Enable sites to qualify, initiate, and support investigators and study teams from any location in minutes with role-based automation of delegation, credentialing, training, and access to the most current protocol version, all from a mobile clinical portal.Â
Ensure sites maintain file organization with folders, keywords, and naming conventions that are always up to date.Â
Rapidly and accurately collect and prepare site documents with site collaboration and eTMF integration options to DIA, and other reference models, available out of the box. Â
CONNECTED SITE OVERSIGHT
Streamline collaboration across every site.
Activate investigators, monitor site activity, and manage regulatory workflows securely from one connected system.
RealTime’s eReg/eISF solutions are Part 11, GCP, SOC2, HIPAA, and GDPR compliant.Â
Share documentation from your IRB, email, vendors, labs, facilities, sites, and more. Â
ISFs remain up to date with most current sponsor-provided documentation while eliminating redundant efforts for site document distribution.Â
