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DM-Encompass has been continually refined over the past 20 years to provide clients with a user-friendly system that is validated according to 21 CFR Part 11 principles, including unique login credentials, role-based security, encrypted transfer and secure storage of data, investigator sign-off for authenticity and a comprehensive audit trail. The framework of DM-Encompass and generic functionality is validated; however, customization requires additional validation. DM-Encompass incorporates tracking, data entry, file upload and reporting features in one system to easily generate triggers and reports to monitor quality indicators identified during risk assessment, as well as to prompt for items requiring follow-up. The tracking module captures the subject’s consent preferences (e.g., main protocol, ancillary studies, or contact for future studies) and generates subject-specific visit checklists that reflect the assessments required for collection. Data entry of the checklists into DM-Encompass creates triggers regarding required data entry of CRFs, upload of media, transfer of specimens and Source Data Verification. Media, such as an ECG file, is linked to the subject’s visit/assessment, and upon upload, is renamed using a standard naming convention. Media files can also be flagged for review by an expert reviewer. Media and associated metadata are securely transferred for analysis and archival. DM-Encompass tracks the life cycle of specimens and associated metadata from collection to final storage.

Features of DM-Encompass
  • Subject, media and specimen tracking throughout the investigation life cycle
  • Checklists to record evaluations or CRF panels completed at each study visit
  • Ability to upload source documents (e.g., Consent/Assent Form, redacted laboratory or other clinical finding reports, images) for regulatory compliance and subsequent SDV
  • Ability to randomize 1) subjects into treatment groups based upon pre-specified stratification criteria or 2) clinical information requiring SDV utilizing risk-based monitoring approaches
  • User-friendly data entry interface that reflects appearance of CRFs and source documents
  • Custom coding that requires SDV prior to advancing the subject forward in the protocol
  • Automated validation checks and triggers to flag items or events requiring follow-up based on risk assessment
  • Real-time reporting listing data elements requiring clarification or subjects requiring follow-up
  • Use of electronic signatures to document authenticity of source documentation and information entered by study investigators
  • Audit log, data lock and role-based security

DM-Encompass and its corresponding processes results in:

     ✔  High recruitment, retention and visit compliance rates
     ✔  Low lost-to-follow-up and withdrawal rates
     ✔  High assessment completion rates
     ✔  High quality data
     ✔  Clinical staff engagement facilitated by site monitoring performance indicators
     ✔  Effective and efficient monitoring
     ✔  Reduced cost