What is SimpleCTMS?
SimpleCTMS is a Clinical Trial Management System (CTMS) designed to offer the benefits of a CTMS without the extensive upfront financial and resource commitments associated with traditional enterprise systems. It provides early-stage drug developers with a scalable and cost-effective solution to enhance the management, performance, and study startup costs of clinical trials. The system supports large, interdisciplinary global teams or small studies and teams, offering features such as multi-study and portfolio management, well-defined user groups, and support for both blinded and unblinded user types.
The platform runs in standard web browsers, is portable for future studies, and supports 21 Part 11 compliance. It includes secure cloud hosting in the US from a validated provider, with a Software-as-a-Service model that covers monitoring and maintenance. Designed by clinical experts and built by technology experts, it is backed by a quality system using validated software processes. Support includes a dedicated client manager, technical assistance from clinical software experts, online video training, and optional customized training and professional services.
Features
- Easy to Use: Flexible and customizable interface
- Web-Based: Runs in standard web browsers
- Scalability: Supports large global teams or small studies
- Portability: Portable for future studies
- User Management: Well-defined user groups and support for blinded/unblinded users
- Multi-Study Management: Handles multiple studies and portfolio management
- Compliance: Supports 21 Part 11 regulations
- Hosting: Secure cloud hosting in the US from a validated provider
- Support: Dedicated client manager and technical support from experts
- Training: Online video training and optional customized services
Use Cases
- Managing clinical trials for early-stage drug developers
- Improving study startup costs and performance in clinical research
- Supporting interdisciplinary global teams in clinical studies
- Handling multi-study and portfolio management in clinical trials
- Providing compliance with 21 Part 11 regulations for clinical data
