Data Management Oversight & Support
Data Management Oversight & Support is a core service that ensures accurate, timely and complete data entry from sites, vendors and systems into the appropriate clinical databases (Electronic Data Capture, laboratories, etc.).
It directly impacts data quality, regulatory compliance and the timeline to database lock, making it a valuable service to Sponsors and CROs.
Our data collection support services reduce delays and strengthen data integrity from day one.
Support Your Study with Clean, Timely Data.
Data management oversight & support typically encompasses the following components:
Data Oversight & Data Quality Planning
- Develop of Data Management Plan, Protocol Deviation Plan and Data Quality Plan
- Manage regular data quality reviews
- Agree and monitor data entry Key Performance Indicators (KPIs)
- Manage review of data trends (e.g., Frequency, Type and Severity of Reported Adverse Events)
eCase Report Form (eCRF) & Electronic Data Capture (EDC) System Setup
- Support design, testing and validating eCRFs
- Crosscheck data points against protocol endpoints
- Provide input on data flow, visit structure and edit checks
- Support User Acceptance Testing (UAT) and feedback collection
- Coordinate EDC vendors (e.g., Medidata Rave, Veeva, Oracle)
Site-Level Data Entry Support
- Track site data entry status (per visit, per subject)
- Send reminders to sites for outstanding data
- Train site staff on EDC systems and query resolution workflows
- Troubleshoot access or entry issues
Vendor Data Integration Support
- Track incoming data from labs, imaging, or ePatient Reported Outcome systems
- Reconcile third-party data feeds with EDC
- Coordinate vendor tech teams, minimising integration updates or delays
Query Management
- Track site data entry vs. monitoring progress
- Track open/closed queries by site
- Support sites with clarifications or re-entry
- Highlight recurring data issues to clinical and data teams
- Identify sites which are outliers in data entry and may require additional support
Data Monitoring & Quality Checks
- Conduct data completeness audits
- Track missing pages/visits
- Analyse data entry lag time
- Summarise site performance based on data quality