Unified eClinical Solution

We 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.

Clean Data for Clinical Management

The Data Management Timeline Starts Early
and Moves Forward with Constant Thinking

Clinical Data Management Timeline

Data Review Tools Take All Forms.
At Axiom, We Focus on Ensuring that Any Aspect of the Data Can Be Easily Accessed and Reviewed.

Clinical Data Management Tasks

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

Better decisions. Shorter timelines.
Unified Technology. Unmatched Service.