Data Management

Our experienced team of Data Managers are on-hand to advise and support all aspects of data capture and analysis from CRF design through to database lock. We have extensive experience in all phases of trials and work closely with both the clinical and reporting teams to ensure the highest quality data. We are part of Medrio's Partner Program (Medrio is a fully functional yet affordable electronic data capture system), and can offer cost-effective solutions to suit all needs.

Our services include:

  • Cross-functional biometrics team plans
  • EDC, paper CRF and hybrid options
  • Risk-based monitoring
  • IWRS
  • CDASH standard datasets
  • Database build and validation
  • Data entry
  • 3rd party vendor oversight and data transfer planning
  • Extensive edit checking
  • Clinical Team and Site training, mentoring and support with EDC
  • Site metrics for CRF completion and Query Resolution
  • Continual Quality Control review including audit trail logging
  • MedDRA and WHODrug coding
  • AMP, cell therapy studies, Observational, Device and Marketing studies