Clinical Data Management

Our clinical data management team is guided by industry standards and strictly adheres to the Good Clinical Data Management Practice (GCDMP) guidelines.

We use the Medrio EDC system as the primary data collection and management tool supported by rigorous internal Standard Operating Procedures.

Our key deliverables include:

  • eCRF design

  • Database design, validation and user acceptance testing

  • Edit check programming and testing

  • Data review and cleaning

  • Data coding for adverse events, medical history and concomitant medications

  • External data import and reconciliation

  • SAE reconciliation

  • Custom status reports for during the life of the study.

Our processes are supported by:

  • Clinical Data Management Plan

  • Data Validation Checks

  • SAE Reconciliation Plan

  • External Data Transfer and Reconciliation Plan

  • Database Lock Checklist.

Our goal is to shorten the data management set up and delivery timelines, whilst maintaining data integrity by using systems and processes that are compliant with global regulatory requirements, including the ICH guidelines and 21 CFR Part 11.​