MainEDC™ COVID-19 Pack

Data Management 365 urgently releases MainEDC™ COVID-19 Pack, a validated solution that supports clinical research in a pandemic environment.  

• Remote Monitoring with direct Source Data upload by Investigators ( Photo, Scan)
• Emergency changes due to possible deviations from original protocol
• Isolation of clinical sites
• Work from home 
• Process continuity support
• Accelerated start of COVID-19 projects

For all our current customers, MainEDC™ COVID-19 Pack extension is free! 

Our offer:

• Tools for implementing FDA* guidelines for clinical trials during COVID-19 Pandemic**. 
• Full remote monitoring capability
• 24×7 from any device
  • Instant access by the project team to the data entered by investigators
  • Secure remote monitoring mode – Source Documentation Review Tool
  • Project monitoring via recurring Email reports
  • Paperless project support 
  • Validated electronic signatures
  • QA support for research processes 

• Keep your staff and Investigators informed at all times – Documents and Study News share tool (Email, SMS).
• Sponsors awareness (ALCOAC)
  • Tools: Dashboard + KPI Report + Advanced Report Tool with 40 Predefined Reports
  • Real-time data export to SDTM/SAS/XML/XLSX/CSV
  • WHODrug, MedDRA, ATC, ICD coding and Auto-coding within the system 

• Quickly start your COVID-19 study  
  • Extended support
  • Full or partial project cloning 
  • Online eCRF approval in the system, without extra paperwork 
  • Instant implementation of protocol amendments

• Quickly update your study according to new requirements
  • Dynamic design support
  • Full control over Visit schedule 
  • Fast transition to EDC in projects running on paper CRF
  • Protocol and Informed Consent Form versioning support
  • Study paths support 
  • Hybrid study model maintenance
• Deviations control
  • Protocol Deviations Tracker according to the New FDA Guidelines*

• Reshape monitoring
  • RBM Dynamic settings 
  • SDV at any level:
    • Field, Page, Visit, Subject, Site, Country
    • Flexible rules for verification based on Site KPI, Confidence Interval, Country/Area Rules, Investigator Assessment
    • Selection of Critical data for verification, review and approval
• Integration with 17 labs and 24 software vendors, full integration with Flex Databases CTMS
• We will help you reconfigure your system to suit new life scenarios 

Our experience:

• Over 1,000 clinical trials on platform
• 32 studies with Central Monitoring
• 114 studies with Risk Based Approach 
• 109 studies with partial SDV
• 218 studies without MV
• 100% of our clients use RBM-driven KPI Report
• 2 projects on COVID-19 already being configured with eCRF, randomization and logistics 

We offer our validated solution:

• Compliance: GCP E6 R2, SAMP 5, 21 CFR Part 11, GDPR, HIPAA
• Validation: 36 QA, IT and Software Development Audits
• Security: 9 qualified Data Centers worldwide 
• Advanced clustering, replication and backup procedures
• Audit trail based on blockchain technology 
• 5 patents

MainEDC™ COVID-19 Pack will be included in the weekly release on March 25.

To rebuild your project or to start a new project, please contact us 

* FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

** For more materials, please contact us Your Team Data Management 365