News

20 March 2020 News

MainEDC COVID-19 Pack

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

  • 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 operation capability

  • 24x7 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

 
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