Say Goodbye to Excel and Other Standalones
With the BSI CTMS you have an instant overview of all milestones and activities, patient recruitment and randomization status, risk-based site monitoring including feasibility portal, and issue tracking. You can -manage your sites and Investigators, the trial master file (eTMF), medical and non-medical supplies, and all other relevant information. You’re enhancing the efficiency of your trial management in a single glance. Even better? With frequent updates and re-releases, you stay up to date with all top industry regulatory requirements and necessities.
Study Design
Individually set up the requirements of your clinical trials entirely in BSI CTMS according to the study protocol.
- Flexible study data setup with high-level information for phase 1…4 trials, such as, therapeutic area, cost estimate, number of planned sites and patients
- Group trials below products and indications (deceases)
- Regions and Countries and regions
- Milestones and activity plans
- Risk based monitoring plan
- Trial teams
- Involved organizations
- Patient enrollment plan
Investigators & Sites
The BSI CTMS helps you find all the information you’re looking for in one place. Select investigators and sites based on post-study site assessments, experience and capabilities. You can also set up site contracts and plan patient enrollment directly in the system.
- Prepare and send out feasibility questionnaires to potential new sites
- Search for trial centers based on historic site and investigator performance
- Track patient recruitment
- Plan patient visits and track their status
- Track and train personnel at trial centers
- Manage site contracts
- Manage addresses and check for duplicates
- Manage and track entire communication threads with the sites
- Set up a post-study site questionnaire to evaluate their performance
Milestones & Activities
Always know where you are in the process: plan and track your study, activities, and country/site milestones.
- Milestones and activity management on all levels, from product to site
- Event-based automatic updates for milestones
- Alerts and notifications, with escalation
- Personal dashboard with activities and tasks to be performed. The BSI CTMS tells you what’s next on your list!
Trial Master File (eTMF)
With the BSI CTMS, you can manage your documents within the integrated Trial Master File (eTMF). This takes place in the same software you use to conduct your trials.
- Integrated eTMF with full support of your eTMF structure or the TMF Reference Model
- Controlled trial master file access for all study partners e.g. sponsors and sites
- Process workflow for creating, reviewing, approving and electronically signing documents
- Version management for documents
- Document plan set up and tracking: upload, link or save documents
- Document deadlines with alert function
- Customized document template creation, ex.: for monitoring reports and follow-up letters
- Individual document download— or, download the complete trial master file with metadata cover page for each document
- Optional PDF/A document conversion on download
- Document viewer
Risk-Based Monitoring
Complete monitoring visit planning and execution entirely in the BSI CTMS. Say goodbye to piles of extra paper!
- Set up a risk-based monitoring plan (RBM) according to ICH GCP E6 R2
- Plan and conduct monitoring visits
- Workflow process for creation, review and approval of MVRs (monitoring visit report), including electronic signatures
- Automatically create pre-confirmation and follow-up letters
- Offline monitoring
- Plan and track patient visits and enrollment
- Track paper CRFs
- Source data verification (SDV)
- Track risks, issues, protocol deviations and (S)AEs
Learning Management System (LMS)
The BSI CTMS includes an integrated Learning Management System (LMS) to simplify training and help your team hit the ground running.
- Create document training programs for your study and site teams
- Send notifications regarding outstanding trainings to end users
- Confirm completed training with an electronic signature
- Track required trainings among internal and external study team members
- Comprehensive training reporting
Trial supply management (RTSM)
You can randomize and track your complete medical and non-medical study material in BSI CTMS to keep track of your various stocks, orders and upcoming shipments.
- Manage medical and non-medical study material
- Set up a study material plan for a trial
- Manage and track orders and shipments
- Create delivery notes
- Manage global and local stocks and warehouses
- Enhanced alerting functionality: ex. low stock or delayed shipments
Contracts and Invoices
Keep track of your contracts and invoices with sites and other vendors for your clinical trials.
- Create and track site and vendor contracts
- Link contracts to master agreements
- Plan and track all incoming invoices from sites and vendors
Finances
Monitor every aspect of your clinical trial budget and costs. You can carry out all your financial tracking activities directly in the BSI CTMS.
- Create budget proposals for sponsors
- Plan and track study and site budgets based on activities
- Compare planned and actual costs
- Track investigator payments
- Invoice tracking
- Sunshine act reporting
Reporting
BSI CTMS empowers every user to create customized reports with our unique, flexible reporting functionality—with no extra permissions needed. Configure your reports using all available data in the BSI CTMS in a couple easy steps and export the data to Word, Excel or PowerPoint. Want to save time? Use our pre-established reporting options for added convenience!
- Adapt the object dashboards to your needs
- Create general reports for all users or specific user groups
- Create, manage and export personal reports
- Create a trial overview PowerPoint report for management
