BSI CTMS (Clinical Trial Management System)
With BSI CTMS, you have a clear overview of all the activities required for managing your clinical studies and overseeing their performance.
Functionalities such as milestone & activity tracking, patient recruitment overview, risk-based site monitoring, issue tracking, budgets & contracts, offers a one-stop shop for enhancing overall trial management efficiency.
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BSI CTMS stands out with an intelligent interface, intelligent data visualization, and user-friendly functions tailored for pharmaceutical, biotech, CROs as well as academic sponsors.
The system’s intuitive interface helps to streamline daily work and continuously evolves to meet market demands through close collaboration, making it a versatile and adaptable software application.
- Study Design
- Site and Investigator Management
- Enrollment Tracking
- Reporting
- Integration with other systems
- Financial Management
- Study Timeline and Milestones
- Trial Supply Management
- Risk-based Site Monitoring
BSI CTMS Factsheet
Discover BSI CTMS in just 2 pages.
Clear, concise, and packed with compelling insights.
What Clients say about BSI CTMS
1. How does your CTMS help ensure compliance with regulatory standards?
BSI CTMS provides a full audit trail capturing the details required by GxP requirements. The audit trail is visible for the end users on almost all dialogs and system admins can create extensive audit trail reports within the admin view.
The system is also compliant with the 21 CR Part 11 for electronic records and signatures, and access to data can be restricted on a granular level.
2. Can the system integrate with our existing tools and adapt to our specific workflows?
BSI CTMS can integrate with external systems by using its REST API (standard data loader/provider). If the external system is not able to call the REST API, file-based interfacing is also possible. In general, BSI is flexible regarding the technologies used for interfacing and has past experience using web services (SOAP/REST), file imports, message queues, database links and proprietary technologies.
BSI also has standard interfaces in place with several external eClinical systems, e.g. Veeva eTMF, Merative EDC, Greenlight Guru Clinical, LedgerRun etc., which can be implemented fast and efficiently.
3. What measures are in place to ensure data security and privacy?
BSI Information Security Management System as well as the cloud service provider (AWS) are ISO 27001 certified guaranteeing the security of your data. Additionally, data processing agreements are signed to ensure contractual liability for ensuring data integrity, recoverability, availability etc.
On a system level, BSI CTMS provides role-based access, which allows the definition of individual user access, showing data on a as-needed basis.
4. What support and training are included during implementation and ongoing use?
As part of the implementation, BSI offers extensive key user & system admin training to equip the customer with the knowledge to maintain their system independently and train the end-users. If needed, BSI can also support with training the end-users.
After go-live, BSI will conduct monthly support meetings to discuss challenges, change requests, future release etc.
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