ethica CRO

Data Management

ethica CRO's experienced data management team will guide you in selecting the best data collection tools for your budget and timelines. Our computerized systems meet the industry's highest standards and are all 21 CFR Part 11 compliant. As a result of an ongoing training program, the members of our data management team are experts in the use of commercial clinical data management systems such as Oracle® Clinical as well as our proprietary in-house systems.

Our team will work closely with you from study initiation to database lock using either your SOPs or ethica CRO's accredited SOPs.

Our service includes:

  • Data management and validation plan development
  • CRF design
  • Independent double data-entry with a third reviewer
  • Single data-entry with 100% entry verification by an independent reviewer
  • Data clarifications (DCF) management with investigative sites
  • SAE reconciliation
  • Data transfers
  • Laboratory data imports
  • SOP development and review
  • Pre-FDA auditing

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