Clinical Data Management 

OUR TEAM’S EXPERTISE

Clinical Data Management Support:

  • Comprehensive Data Support:
    • Our clinical data management team is equipped to assist with all data capture and analysis aspects.
  • Efficient Data Collection and Delivery:
    • We guarantee the efficient collection and delivery of top-quality data.
  • Software Expertise:
    • Our team possesses expertise in various software solutions.
  • Partnerships with Data Management Platforms:
  • Tailored Solutions:
    • Our clinical data managers are dedicated to providing the optimal solution for your clinical trial.
  • One-Stop Data Management Hub:
    • We serve as a single destination for all your data management activities.

HOW WE HELP YOU

Explore our clinical data management services

  • Consulting services
    • Strategic program planning
    • Protocol review
    • EDC selection
  • Case report form (CRF) design
    • Incorporating the latest SDTM implementation guides
  • Database services
    • Design, development, and maintenance
  • Data validation
    • Programming and testing
    • Including edit check and manual review specifications
  • Data management
    • Data entry
    • Data cleaning and query management
    • Medical coding using WHODrug & MedDRA dictionaries
    • Serious adverse event (SAE) reconciliation
    • Management and integration of local laboratory reference ranges with CRF data
    • Integration, verification, and reconciliation of external electronic data
  • EDC (Electronic Data Capture) services
    • Selection and end-user training
  • Database finalization
    • Locking and archival
    • Database transfer

Our Consultative Approach

  • Consultative Data Management:
    • Our clinical data management team offers a consultative approach to data management tasks.
  • Goal-Oriented Understanding:
    • We comprehend your objectives and offer constructive feedback.
  • Process Flexibility:
    • Our processes are adaptable and can be tailored to your specific needs.
  • EDC Solution Selection:
    • Our clinical data managers can identify the most suitable Electronic Data Capture (EDC) solution for your requirements.
  • Phase-specific Planning:
    • We can create a comprehensive plan for each project phase.
  • Guidance and Support:
    • Our clinical data management team assists in demystifying data management components and guides key interim stages, ensuring successful project completion.

Data Managers

  • EDC System Certification:
    • Our data managers hold certifications in a minimum of one EDC system.
  • Database Build Expertise:
    • We possess a deep understanding of database build considerations and are equipped to assist with your data management requirements.

 

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