Study Startup and Oversight

Immediately start tracking site startup activities, study milestones and view alerts for key items. More specifically:

• Integrated site startup tracker comes standard with activities from site selection through enrollment
• Quickly customize the startup tracker per your team, Sponsor requirements, or study needs (like Excel!)
• Easily apply the customized startup tracker across studies for consistency across your SSU teams
• Use Study Milestones to track dates and dependencies; view chart and dashboard progress
• Manage site essential documents per eTMF model and track progress of site startup document packets
• Utilize action items and alerts for team members prioritizations

Monitoring Activities

Manage site visits across studies, visit report completion progress, track study documents, and oversee monitoring plan adherence. More specifically:

• Calendar site visits, view team member vacations, and assess team resourcing across studies
• Manage visit report drafting to approval; run Visit Report Metrics report for monitoring plan compliance
• View site documents, track collection/review/approval status, perform ongoing TMF reconciliation
• Prioritize items required for activation; utilize document expiration alerts to proactively manage renewals
• Easily manage site personnel contacts in one place including supply addresses, study roles, contact details
• View comprehensive action items across teams and studies; trend protocol deviations across sites

Subject Management

Assess study recruitment efforts against targets, trend screen failures and protocol deviations, and track subject details by visit. Manage enrollment activities by cohort and protocol version and utilize standard data import features to automate your tracking needs. More specifically:

• Manage ICF signature, screening, enrollment/randomization, ET and/or completion dates
• Manage visit schedule changes associated with protocol amendments and study design criteria
• Oversee subject compliance with protocol visit windows, completion of protocol procedures and data entry needs
• Review and triage protocol deviations arising from electronic visit reports
• Utilize EDC integration to populate subject records, visit details and support site payment activities
• Quickly customize the tracking view to support additional protocol specific needs

Site Contracts and Payments

Define investigator contract templates by country, currency and fee types. Manage fixed fee and subject-based contracts and use the built-in invoice generation features. Additionally:

• Define and manage subject based contracts which include the item name, item fee, overhead fee, holdback amount, and associated study visit(s);
• Define and manage fixed fee contracts for routine items such as EC submissions, lab setup and staffing
• Manage multiple contracts per site for cohort studies and protocol amendments
• Assess subject payments against contract fees for screening and enrollment records and per visit detail
• Set items for full payment, partial payment, holdback payment or ad-hoc payment
• Generate detailed invoices to accompany site payments and/or support Sponsor reimbursement requests
• Manage invoicing activities against payments made and/or funds received
• Run standard CTMS finance reports across one or more studies

Additional Benefits

• Create new studies based on existing studies for consistency within the same Sponsor
• Customized trackers can be utilized across studies to strengthen and standardize workflows
• System picklist values may be customized to meet your needs
• Admin users may facilitate subscription changes directly within the application without the need for assistance from the CTMS vendor
• Global teams may collaborate across studies with appropriate data view and CTMS Account type settings
• Sponsors may be invited into the CRO workspace by study and with appropriate portfolio data views
• EDC integrations may be established for different EDC systems and studies

Document Management

CTMS includes an integrated eTMF! Pick from the DIA reference model, the SimpleTrials model or a build-your-own eTMF model. Utilize document tracking features, file upload capabilities or both.

• Use different TMF models to accommodate Sponsor needs
• Set essential documents required for activation, study closure and items requiring EC approval
• Quickly and consistently track document status, version and date, expiration date and status
• Manage protocol amendments or country-specific items
• Reuse custom TMF structure and definitions for other studies
• Post documents via single or multi-file upload; use zip download for Sponsor TMF return at study end
• Add and order folders to support company documents, team documents, study or site-specific items

Electronic Visit Reports (EVRs)

Design EVR templates, specify appropriate EVR approvers, and author and approve EVR reports directly in the CTMS. View outstanding reports and oversee completion metrics for compliance with the monitoring plan. Utilize reminder and workflow alerts to guide on-time approvals. Specifically:

• Quickly create EVR templates per Sponsor requirements or internal templates
• Annotate CRA completion instructions directly in the template
• Easily setup Q & A sections, specify appropriate response, and indicate when a comment is required
• Build EVR templates using tables such as action items, deviations, IP review, ICF and data review, SAEs, and screening and enrollment
• Include confirmation and follow-up letters as EVR attachments to facilitate review and approvals
• Associate final EVR templates to studies for immediate use
• Use in-app and email alerts for EVR drafting through final approval; use alerts to manage due and nearly due reports for compliance with monitoring metrics
• Final approved e-signed reports and associated attachments are automatically posted in the eTMF

Contact Management

Manage a comprehensive contact database of sites, sponsors, teams and vendors. Visualize records associated with multiple studies and manage global contact details in one place. Additionally:

• Site and contact record import comes standard and with built-in templates
• Manage multiple addresses per site to designate supply shipment versus business addresses
• Manage title, phone, email and physical address for consistency across studies
• Track site staff changes, study roles, CRA-site associations and generate CTMS account invitations
• Specify team members authorized to approve EVRs created within CTMS
• Run CTMS roster reports for sites and teams for one or more studies

Dashboards, CTMS Reports and Exports

• 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
• Custom columns added in application views are available in CTMS Reports