Study Startup Tracker 


SimpleCTMS Study Startup Planning and Tracking features are flexible to be as comprehensive or as light as you need. It's all included with our CTMS offering. Features include:

Milestone Planning at the Study, Country and Site Level

  • Set milestone dates at the study and country level.  Use our study milestones template or customize the milestones.
  • Target site activations & SIV planning and tracking.
  • Target enrollment planning at the study, country and site level.
  • FPI Planning super-tracker combines key activities from activation, regulatory, IRB/EC and enrollment.
  • Country identification and selection based on regulatory agency timelines and submissions.

 Study Milestones screenshot shows customizable view with country level trending (click to enlarge).

Site Selection Activities

  • Pull sites from the CTMS contacts directory (by region, investigator specialty, IRB type or site type).  
  • Import sites/investigators from an existing data source (e.g. spreadsheet), or integrate with IWRS, external investigator database, etc.
  • Key document tracking, e.g. non-disclosures, surveys, budgets, etc.
  • Integrate CRA visit calendar for assigned and swat teams.
  • Consolidated CRA areas for information and document sharing.

Regulatory Document Tracking

  • Set regulatory document collection requirements at the study or country level.
  • Track collection and review status by document and version.
  • Identify outstanding required documents.
  • Upload and manage document files.  Electronically sign your uploaded documents for 21 CRF Part 11 support.
  • Email alerts to notify key team members of document collection and expiration activity.

Screenshot of the Reg Doc tracking view (click to enlarge)

IRB/EC Tracking

  • Plan and define IRB/EC approval needs for each site, or multiple sites covered by a central IRB.
  • Track submission status and meeting status by document.
  • Track approvals for updated documents such as protocol amendments.

Detailed Enrollment Planning

  • Enrollment targets can be planned on a monthly basis per-country and per-site.
  • Planning for high enrolling sites and countries.

Screenshot of a startup metrics report

Contract, Budget & Payments Management

  • Independent tracking of budgets and contracts.
  • Tracking of different site contract types.
  • Plan and track budgets, fixed-fees and per-subject fees.
  • Track fixed and per-subject payments.
  • Vendor contract status and monthly cost planning.

Analytics, Reports & Visualizations

Reports, Charts and Rosters include:

  • Site dashboard with charts and data visualizations
  • Site and Investigator Rosters
  • Site Activations and SIV Progress Report
  • Critical SIV Milestones Report
  • Regulatory Document Comments and Approvals Report
  • Mapping of sites, including global view and drill down to local/street level.

 

Screenshot of interactive site map (click to enlarge).

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