Services & Solutions

Data Management

Our mission is constant data quality improvement and clinical trials management process optimization to help you manage your trials in the most efficient way.



  • CRF/eCRF design
  • Automated checks specification
  • Database development
  • Database validation
  • UAT in EDC systems
  • Management and reconciliation of
    e-transferred data: central labs, central readers, etc
  • Clinical database transfers: interim, final
  • Query generation and resolution
  • Medical coding
  • AE and SAE reconciliation
  • Database lock
  • SAS datasets
  • Data export in any format
  • CDISC SDTM standard

Advantages

  • Total control of your trial from eCRF design to final data export

  • Various reports generation

  • Database setup and data verification with manual and automated tools

  • Detailed eCRF design in accordance with study protocol

  • Team of data management specialists with profound experience in clinical trials

  • Quick adjustments to protocol alterations

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EDC & IWRS

Use EDC and IWRS system to gain total control of your data. Increase data quality while reducing risks and costs on randomization, data capture and management with Electronic Data Capture and IWRS system. Data capture and management within e-system.

  • Fully managed Cloud Hosting
  • Back-up and risk mitigation
  • Unlimited number of users at no extra charge
  • Unlimited help desk support
  • Trainings for DM staff, CRAs and Investigators
  • Generation of standard and project-specific reports
  • Fully-integrated accessible audit trail
  • Study Build, Data Capture & Data Integrity
  • Self-service unlimited mid-study changes
  • Self-service management of users, studies and sites
  • Paper CRF visualization
  • Viewing, updating, querying and locking data
  • Configurable DM and clinical operations workflows
  • Comprehensive graphical representation of forms' statuses
  • Data validation
  • Ability to track SDV
  • System supports all types of randomization

To learn more about the system, follow this link

Advantages

  • The system is validated and 21 CFR Part 11 compliant

  • Constant project progress control in real time

  • Data security: secure data storage in qualified data centers, data backups, access control to the system

  • EDC&IWRS system significantly saves time, efforts and financial resources in comparison to IVRS and paper CRF usage

  • Individual system adjustment for each study

  • User-friendly system does not require advanced technical skills. Access to the system from any device at any time

Have a question? Please get in touch!

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