Data Management

We provide comprehensive data management services for clinical trials across all phases of clinical development, ranging from first-in-man to international, late phase trials.  Our experienced data management team has a track record of delivering high-quality, CDISC-compliant data, on time, using validated 21 CFR part 11-compliant systems and processes.  We believe that the key to a successful trial is clear communication combined with the flexibility to meet the requirements of our clients, and our team, led by your trial’s lead data manager, will work with you to meet your expectations and objectives.  Your lead data manager will ensure that, from design through to database lock, your clinical trial data are in safe hands.

View our Data Management brochure.

Our clinical data management services include:

  • EDC/paper study set-up & management:
    • CRF design (paper or eCRF), using tried and tested templates developed in collaboration with clinical staff over > 25 years
    • High-quality databases, verified by review and user acceptance testing
    • Rapid database deployment:  ‘go-live’ before first dose, and agile response to protocol amendments
    • Regular status reports and custom reports
  • Data Management Plan (DMP)
  • CRF annotation & review, applying CDASH and CDISC (Clinical Data Interchange Standards Consortium) standards
  • Data validation specifications
  • Edit check programming and testing
  • Rapid data entry and processing
  • Query Management
    • Rapid query resolution through active management
    • Availability of remote data review
    • Detailed audit trails to maintain data integrity and compliance with ICH Good Clinical Practice (GCP)
  • Medical coding using MedDRA and WHO DDE:
    • Medical history
    • Adverse events
    • Medication
  • Data reconciliation & transfer:
    • Reconciliation of (S)AEs and protocol deviations
    • Reconciliation and transfer of laboratory data and of PK, and other externally-provided electronic data
  • Data management consultancy