SCAD RMS (Regulatory Management System)
SCAD RMS (Regulatory Management System) is a fully-integrated, web-based solution that focuses on the constructs needed to effectively manage and monitor the regulatory side of a clinical trial and meet the business management and operational requirements of a Clinical Research Organisation’s Regulatory Affairs Department.
Based on the extremely powerful and flexible “Swift Channel Application Development” technology framework (SCAD Framework), the SCAD RMS system offers the flexibility required to more effectively manage, monitor and control regulatory affairs over multiple trials and countries from a single application system.
SCAD RMS provides a platform and repository for the collection and management of regulatory documentation, the compilation and submission of clinical trial application dossiers and subsequent tracking of the regulatory correspondence through to clinical trial end. Powerful document management, document generation, automated communications and workflow capabilities ensure efficiencies by way of reducing administrative time and efforts in the compilation of clinical trial applications and ongoing tracking of the clinical trial process, thereby minimizing errors and duplication, streamlining regulatory processes and ensuring consistency over all projects.
The SCAD Framework technology enables changes to the system to be implemented very quickly, easily and economically as most changes are simply data configuration related as opposed to code changes and its robust design, scalability and security make it the ideal platform for configuring systems for organisations of any size.
Key features and benefits of the SCAD RMS solution include:
- The alignment of IT systems with business needs, including the ability to adapt rapidly to changing business processes and regulatory compliance needs
- The provision of a single view of a trial including consolidated and fully integrated information related to the sponsor, trial, trial countries and country competent authorities (all trial related data including documentation in one place)
- The provision of a single view of the business including consolidated and fully integrated management information related to key performance areas across the enterprise
- Ease of use resulting in minimal user training and enhanced user satisfaction with greater accuracy, consistence and productivity
- System Administrator managed “tooltips” and “help”
- Secure, flexible role based access to authorized content and functionality from anywhere where there is internet access
- Integrated document management including version control (document uploading, downloading and viewing at the click of a button)
- Powerful workflow capabilities enable the streamlining and automation of regulatory processes to improve accountability, accuracy, efficiency and control, e.g. emails and other notifications such as SMS can be automatically triggered by business rules
- Document generation provides for the auto-population, generation and emailing of documents from pre-defined templates, e.g. compilation of application dossiers, payment requests and cover letters
- Powerful and easy to configure MI reporting and real-time metrics
- Low bandwidth and infrastructure requirements (low capital investment and ongoing costs)
- The ability to integrate with other internal and external systems if necessary