Portfolio Management

Manage content that relates to multiple studies such as calendar events, contact and organizational records, documents and Electronic Visit Report (EVR) templates. Run CTMS reports in common formats for single or multiple studies. Additionally:

• Quickly view study recruitment efforts against targets
• Access alerts for study milestones, action items, document expirations, and electronic visit reports
• View and manage calendar events for site visits, team vacations and general events across all studies
• Organize folders to support company, team, and study documents; view documents and tracking details
• Look-up organizations and contact records for sites, vendors, IRBs and affiliates; efficiently manage contact details and addresses; view records associated with multiple studies
• Generate CTMS Reports and define custom reports

Site Monitoring & Electronic Visit Reports

Establish standard electronic visit report templates (EVRs) for team and CRO use, assess compliance against monitoring plan timelines, and view details of individual visit reports. Additionally:

• Easily setup EVR templates using Q and A sections, integrated tables for action items and protocol deviations, and include completion instructions for consistency across CRA authors
• Associate final EVR templates to studies for immediate use
• Specify team members authorized to review and approve EVRs
• Utilize built-in EVR workflows and alerts for EVR drafting through final approval
• Assess site trends for protocol deviations, enrollment and screen failures
• View final approved EVRs and associated attachments in documents folder by site and visit

Financial Management

Establish contract templates by country for international studies, multiple contracts per site for protocol versions and track progress of fixed fee payments for EC submission activities. Utilize the generate invoice feature to support site payment details and manage financial activities for check runs for monthly investigator payments. Additionally:

• Setup contracts to include item fees, overhead, holdback and associations with subject visits per protocol
• Manage data and visit completion status for consideration of full and partial payments
• Utilize side-by-side subject visit detail and contract detail to assess payments due
• Manage contract updates for protocol amendments, fee changes and cohort studies
• Generate detailed invoices by site with fixed and subject fees to accompany payments
• Track invoice and payment progress by site and study; run CTMS finance reports for one or more studies

Reporting, Exporting and Dashboards

Utilize exports within a specific tab and view, run CTMS reports with performance metrics and view dashboards for relevant visualizations. Additionally:

• Study specific views support data exports in common formats including Excel
• Dashboards provide visualizations for site selection, startup progress and recruitment efforts
• CTMS reports come standard and can be run across studies for site and team rosters, study and site planning activities, calendar and visit tracking, documents, subjects and financial details
• Customize CTMS reports for additional fields, display order and cross-study reporting needs.

Study Startup and Oversight

Manage study milestones, site selection and startup activities and action items associated with studies. Additionally:

• Import sites and contacts utilizing built-in templates
• Utilize comprehensive startup tracker out of the box or customize by adding or removing columns; use search/sort/filters to highlight study delays
• Refine study milestones including start/end dates and dependencies; utilize chart and dashboard views to prioritize efforts
• Manage site contact records for communication details, study roles, IP and supply shipment addresses, and CRA-site associations
• Assign and track action items and utilize in-application and email alerts

Document Management

CTMS includes an integrated eTMF that supports the DIA reference model, SimpleTrials model or build-your-own model! Set the eTMF model to be utilized per study, upload files and/or track key details for site essential documents.

• Add and order folders to support company documents, team documents, study or site-specific items
• Use standard views, exports and reports to prioritize documents needed for site activation, IRB/EC submission and study closure
• Perform TMF reconciliation activities during the course of the study per built-in tracking features
• Quickly and consistently track document status, version and date, expiration date and expiry status
• Manage protocol amendments or country-specific items consistently for participating sites
• Post documents via single or multi-file upload; use zip download for full TMF
• View final e-signed electronic visit reports and attachments within the site-specific folder

Subject Management and Integration

View progress with screening and enrollment, details of subject visits and assess protocol deviations. Manage subject enrollment by protocol, cohort and visit schedule. Assess subject visits for determination of site payments. Setup and implement EDC integration directly within the CTMS. Additionally:

• Utilize standard subject import feature with built-in template
• Manage key dates such as ICF signature, screening, randomization, ET and/or completion
• Assess and triage protocol deviations reported via EVRs, data reviews and other sources
• Track and trend screen failures, compliance with protocol visit windows and completion of protocol required activities
• Efficiently manage multiple protocol visit schedules due to protocol amendments, cohort studies or complicated study designs
• Establish EDC integrations to populate subject records, visit details, and support site payment activities.

Additional Benefits

• Invite CRO vendors, team members and sites to create accounts and directly manage associated data
• Customize system picklists to meet your needs for study nuances
• EDC integrations may be established for different EDC systems and studies
• Admin users may facilitate subscription changes directly within the application without the need for assistance from the CTMS vendor
• Customized trackers can be utilized across studies to strengthen and standardize workflows
• eTMF structure, essential document definitions and study milestones may be standardized and utilized across future studies