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.  

• 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

• 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