Clinical Data Management

We facilitate the efficient collection and management of your clinical data so you can maximize its value and make better-informed decisions. We do this in a collaborative, transparent way so you can feel confident in the process.

Flexible, global services

We offer flexible Electronic Data Capture (EDC) and study management software options and EDC implementation best practices. Our experts review the specific needs of each protocol to tailor a best-in-class solution for your study.

Combining the latest technologies with our collective knowledge and expertise, we’re equipped to identify and resolve any data discrepancies, proactively identify data trends, and ensure the highest data quality.

Service models are customized to your need, whether full-service, FSP, or hybrid, and we’ll flex to your operating needs. We can bring our own processes and SOPs or adapt to yours and we can staff projects to cover any time zone or study need.

Data management expertise

We combine our collective knowledge and the latest innovations in clinical technology to bring you the most reliable datasets to advance your drug product.

We’ve built dedicated global data management, clinical programming and testing groups comprised of over 150 individuals averaging 18+ years of drug development experience each.

We’ve managed over 350 data management projects and understand the importance of having clean and reliable data to back up your clinical findings and lead your trials to success.

Our data management services include:

  • ECRF design/database development across multiple platforms
  • CDISC/CDASH data standards development
  • Third-party reconciliation management
  • Biomarker data management
  • Medical coding
  • IXRS testing and validation

Data management and clinical programming

Start-up

  • Design eCRFs
  • EDC configuration and testing
  • User acceptance testing
  • Data management plan
  • eCRF completion guidelines
  • Set up third-party data transfers
  • Set up coding
  • Secure file exchange

Maintenance

  • Continuous data quality review
  • Issue resolve queries across medical coding, medical monitoring and biostat reviews
  • Data reconciliation across central labs and SAE
  • Documentation maintenance
  • Subjects ready for ‘soft lock’

Close-out

  • Checklist and internal sign-off to confirm that:
    • All data has been collected
    • All queries are closed
    • All subjects are locked
    • All external data has been reconciled
    • PI is ready for sign off
  • Database ready for ‘soft lock’
  • Database ready for ‘data lock’ by ensuring that:
    • Final data review has been confirmed
    • Checklist and sign-off have been confirmed by the sponsor
  • Final raw data transfer is completed
Global reach, tailored approaches

Personalized clinical research services

Across every stage of your clinical journey, we’re by your side to help you advance through clinical trials to get your therapy to patients and help bring your science to life.

See all our services
Gateway to the globe

Speak to a global expert

Ready to get more value from your clinical data? Our clinical data management experts are ready to help you advance your drug product through its clinical trials.

Schedule a 15 minute call
Leading a new way

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Explore our news and updates as we liberate the clinical research process.

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News

04/28/21

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SHANGHAI, CHINA and MORRISVILLE, NORTH CAROLINA, USA, April 28, 2021 – ...