Data Management

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TRiNDS data managers are specialized in neuromuscular and rare diseases TRiNDS provides full service data management support and offers OpenClinica as its electronic data capture (EDC) system. The data management team can help from database design all the way through to data lock in a timely manner.

  • Data management plan
  • Case report form (CRF) design and development
  • Database design and development
  • Database user acceptance testing (UAT) and validation
  • Edit check specifications and creation
  • Data cleaning throughout the study
  • Database training and helpdesk
  • Third party data transfer
  • Custom reports
  • Medical coding
  • Serious adverse event (SAE) reconciliation
  • Database lock
  • CDISC SDTM datasets

TRiNDS uses OpenClinica for electronic data capture (EDC)

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  • 21 CFR Part 11 and GCP Compliant
  • Online data entry
  • Fully integrated system including a randomization and online participant survey modules
  • Network of trained study team members for data entry and queries
  • Connectivity to the CINRG Quantitative Measurement System (CQMS)