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Data Management

Data management is a critical part of clinical research. The data collected during clinical trials forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development. The generation of consistent, high-quality, reliable, and statistically sound data is therefore essential, with the ultimate goal of assuring that the collected data support conclusions drawn from research. It is with this in mind that R&G provides end-to-end Data Management services. From database design to database lock, we can provide you with fast, top-quality deliverables, every time.

Our Data Management Services Include:

  • Case Report Form (CRF) design
  • Data Management Plan (DMP)
  • Data Validation Plan (DVP)
  • CRF completion guideline
  • aCRF, database design
  • Edit Check programming and testing
  • IVRS/IWRS support
  • Data listings for manual review
  • UAT testing
  • SDTM development in compliance with CDISC Standard
  • Investigator meeting support and EDC training
  • EDC Help Desk support for study conduct
  • Data entry for paper study
  • CRF and DCF tracking
  • Discrepancy management
  • External data transfer and reconciliation
  • Serious adverse events reconciliation
  • Lab Normal range maintenance
  • Ongoing critical variable quality control
  • Ongoing DM status report and (blind) data review report
  • Medical coding
  • Data management audit trial
  • Database lock
  • Data transfer
  • Data management report
  • Study documentation maintenance, return and archive

Please contact us for additional information on how our Data Management team can help improve your data quality and reduce your timelines.

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