Data Management Approach
Axiom’s DM approach is designed to ensure that the resulting data is accurate, scientifically credible, and was thoroughly reviewed against the protocol, GCP and therapeutic requirements.
This is achieved through a multi-threaded approach prior to study launch and during the study operational phase.
Data Management Plan Development
These tasks represent the key areas that Axiom focuses on when developing a DM Plan:
- Client Discussions on Protocol, Data Management Plan Structure
Regular discussions to ensure the protocol/therapeutic requirements are understood and the approach to the DM plans reflects the study needs. - Research / Review of Therapeutic Area
Team review of therapeutic area by lead data manager and supporting team members - Interactive Development of DM Plan
Plan development with regular iterations to client for review/discussion
Incorporation of lessons learned from previous studies / DM Plans - Review of Con Meds / Other Agents
Review of con meds / other agents that are permitted and/or prohibited by study subjects - Test Case Scenarios
Development of test case scenarios
Possible review of retrospective subjects to test against DM plan
Data Management Operations – Live Study
These tasks represent the key elements that Axiom focuses on to ensure high quality, scientifically credible study data:
- Live Data Review against DM Plan:
Ongoing data review based upon data entry and key milestones - Automated Edit Checks for System Data review
System review of key data points with results reported to Data Manager - Site Communication for Queries, Missing Information & other DM items
Ongoing site communication for DM related tasks
Regular client reporting for DM activities - Live Data Management Plan: Ongoing Review / Changes
Regular DM Plan reviews and possible changes - Update Discussions with Client on DM Plan Changes
Updates with clients on possible DM Plan changes, notations, and critical items to flag