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Ofni ClinicalTM
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Create, validate and implement 21 CFR 11 compliant clinical trial databases

Ofni Clinical is a clinical data management tool that creates, validates and implements clinical trial databases based on your case report forms. It provides your organization with an electronic data collection solution for your clinical trials. Ofni Clinical facilitates the conversion from paper based systems to true electronic format. Many clinical databases can be created, implemented and validated in a few weeks. Ofni Clinical also allows for completely paperless CRFs, eliminating the need for duplication of data entry and storage of paper.

Ofni Clinical:

  • Matches your existing Case Report Forms (CRFs), reducing costs for training and implementing while allowing electronic data analysis and review.
  • Automates the creation, review and closing of data querys.
  • Allows for double-data entry and facilitates data remediation.
  • Extensive Edit Check features to identify questionable data entry and support data analysis.
  • Supports existing clinical data standards, like CDISC.
  • Compliant with 21 CFR 11, Annex 11 and HIPAA requirements for electronic data security and management.
  • Backed by the Ofni Clinical Group, ensuring that your clinical trial software and organization meets and exceeds all regulatory practices for clinical trials.

Learn more about Ofni Clinical
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CDER indicating increased inspections for compliance with 21 CFR 11