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.

Study design

Individually set up the requirements of your clinical trials entirely in BSI CTMS according to  the study protocol.

  • Products
  • Indications
  • Study data with high-level information such as type, subtype, therapeutic area, cost estimate, number of planned sites and patients
  • Countries and regions
  • Milestones
  • 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
  • Recruitment
  • 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

Documents

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

Monitoring

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

Reporting

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

Finances

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
  • Invoicing
  • Payment of trial centers and suppliers

Compliance

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