Medidata CTMS™

Enterprise-Grade Trial Management Tools

Centralized trial management tools can help study managers effectively deploy critical resources, proactively address performance issues and streamline operational workflows—representing huge opportunities for budget savings and timeline reductions.

The challenge is getting there quickly and cost effectively, without lengthy, risky implementation projects or costly, disruptive upgrades.

Medidata CTMS™ takes a fresh approach to providing tools that can make a significant difference in your operations today, with a broad and flexible platform to support the business challenges of tomorrow.

  • If you are still managing your studies with spreadsheets, Medidata CTMS offers cost-effective modules to streamline key processes such as Site Payments and Monitoring Visits with proven ROI.
  • If you are outsourcing study operations, Medidata CTMS can provide your project managers and executives with real-time visibility into milestones and metrics.
  • If your current, legacy CTMS is not delivering, Medidata CTMS can help you focus IT investments on upgrading immediate needs first.

Medidata’s enterprise-grade range of modular trial management capabilities include:

Study Planning

  • Timeline and milestone planning
  • Study projections, including predicted recruitment

Study Startup

  • Investigator, site selection and management
  • Investigator and site assessments

Study Conduct

  • Vendor and contact management
  • Mass communication via mail merge
  • Shipping exports and supplies management

Study Management

  • Milestone and recruitment tracking
  • Subject, visit, CRFs and query tracking
  • Subject exemptions and deviations tracking
  • SAE tracking
  • Alerts and notifications, including SUSARs

Financial Management

  • Investigator contracts and payments
  • Timesheet and Expenses

Monitoring

  • Monitoring visit reports
  • Full offline/remote client
  • Upload modified data to CTMS

Regulatory Compliance

  • Essential document tracking
  • IRB/ethics committee submissions tracking
  • Regulatory authority approval tracking

Interoperability

  • Out-of-the-box integration with Medidata Rave® EDC
  • Integration to any EDC, IVRS, CTMS, financial or data-mart/OLAP system and MS Project/Excel
  • AS2, SFTP and CDISC ODM compliant data sharing