Functions of BSI CTMS
Say good bye to Excel and other stand-alone solutions. With BSI CTMS you have an instant overview of patient recruitment and randomization, milestones and activities, trial centers, costs, documents, medical and non-medical supply and all other relevant information and thereby enhance the efficiency our 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.
- Study data with high-level information such as type, subtype, therapeutic area, cost estimate, number of planned sites and patients
- Countries and regions
- Trial teams
- Involved organizations
- Patient enrollment plan
Investigators & sites
Search and find all information in one place with BSI CTMS. Select investigators and sites, set up site contracts and plan patient enrollment with this all-in-one software.
- Selection criteria
- Search for trial centers based on historic site and investigator performance
- Patient visit planning and status
- Train personnel at trial centers
- Contact management
- Address management with duplicate checking
Milestones & activities
Do you know where you are?
Track your milestones and activities and plan accordingly.
- Milestones and activity management on all levels, from product down to the individual patient
- Event-based updating of milestones, including notification
- Alerts and notifications and escalation
With BSI CTMS you manage your documents in the same software that you use to conduct your trials.
- Integrated eTMF
- Version control
- Process for creating and approving documents
- Document deadlines with alerting function
- Document templates, e.g. monitoring reports, correspondence
- Attach, link or save documents
Material & drugs
You can even administer medications and non-medical material in BSI CTMS so that you always keep track of your stock and the next shipment.
- Inventory planning and tracking of non-medical material
- Orders and shipments
- Drug shipment planning and tracking
- Inventory for drugs and non-medical material
- Global and local stocks
Say goodbye to paper! Complete the planning and execution of monitoring visits entirely in BSI CTMS.
- Guided processes for creation and review of MVRs (monitoring visit report)
- Plan and conduct monitoring visits
- Electronic signatures
- Offline monitoring
- Planning and tracking of patient visits and enrollment
- Patient enrollment graphs
- Source data verification (SDV)
- Tracking of deviations and violations of the trial protocol
You can easily configure individual evaluations and save them. All data in BSI CTMS can be used for this purpose.
- Personalized and global evaluations
- Evaluations of specific trial teams
- Ad-hoc evaluations
- Export to Excel, Word and PDF
- Personal cockpit with all to-dos for the individual user
- Alerts and notifications
Keep track of your clinical trial budget and costs. Carry out all financial activities directly in BSI CTMS.
- Budget planning
- ompare planned and actual costs
- Investigator payment tracking
- Payment of trial centers and suppliers
With BSI CTMS you stick to the rules without any difficulties. Our software is compliant with multiple regulatory requirements.
- 21CRF part 11 (electronic records and electronic signatures)
- EU Annex 11 Computerized Systems
- Developed and validated according to procedures based on GAMP5