Data Management

datamanagementWe think about studies differently.

We don’t count the number of edit checks. Nor do we bill for each query issued.

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.

DM Approach

dm_flow

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

DM 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
Flat Rate pricing is key to staying on budget when it comes to your data management services.