Say goodbye to Excel and other stand-alone solutions. With BSI CTMS you have an instant overview of milestones and activities, patient recruitment and randomization, risk based site monitoring and issue tracking, budgets, contracts and actual costs, trial master file (eTMF), medical and non-medical supply and all other relevant information and thereby enhance the efficiency of your trial management. Together with industry experts, BSI extends the functionality release-by-release.
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
Search and find all information in one place with BSI CTMS. Select investigators and sites based on post-study site assessments, experience and capabilities, set up site contracts and plan patient enrollment with this all-in-one software.
- Set up a post-study site questionnaire
- Search for trial centers based on historic site and investigator performance
- Track patient recruitment
- Patient visit plan and track the status of the patient visits
- Track and train personnel at trial centers
- Manage site contracts
- Address management with duplicate checking
Do you know where you are? Plan and track your study, country and site milestones and activities.
- Milestones and activity management on all levels, from product down to the site
- Event-based automatic updating of milestones
- Alerts and notifications, and escalation
- Personal dashboard with activities and tasks to be performed – BSI CTMS tells you what to do next!
With BSI CTMS you manage your documents within the integrated trial master file (eTMF) in the same software that 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
- Set up of document plan and document tracking Upload, link or save documents
- Document deadlines with alerting function
- Set up of your own document templates, e.g. for monitoring reports and follow-up letters
- Download of individual documents or the complete trial master file with meta data cover page for each document
- Optional PDF/A document conversion on download
- Document viewer
Say goodbye to paper! Complete the planning and execution of monitoring visits entirely in BSI CTMS.
- 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
- Automatic creation of follow-up letters
- Offline monitoring
- Planning and tracking of patient visits and enrollment
- Tracking of paper CRFs
- Source data verification (SDV)
- Tracking of risks, issues, protocol deviations and (S)AEs
Learning Management System (LMS)
- Create document trainings for your study and site teams
- Notifications about outstanding trainings to end users
- Confirmation of executed training using electronic signature
- Track required trainings among internal and external study team members
- Comprehensive training reporting
You can randomize and track your complete medical and non-medical study material in BSI CTMS in order to keep track of your various stocks, orders and the next 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 on e.g. low stock or delayed shipments
Keep track of your contracts with sites and other vendors for your clinical trials.
- Setup and track site and vendor contracts
- Link contracts to master agreements
Keep track of your clinical trial budget and costs. Carry out all financial activities directly in BSI CTMS.
- Create budget proposals to the sponsors
- Plan and track a study and site budget based on activities
- Compare planned and actual costs
- Track investigator payments
- Invoice tracking
- Sunshine act reporting
BSI CTMS empowers every user with our unique flexible reporting functionality. Create your own personal reports using all available data in BSI CTMS by pure configuration and export the data to Word or Excel. Or simply use the out-of-the box reports.
- 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