Create, validate, and implement 21 CFR 11 compliant clinical trial databases
Ofni Clinical is a clinical data management tool that rapidly creates and implements secure, regulatory compliant clinical trial databases. Ofni Clinical includes comprehensive search and report features, has strong data validation and edit check options, contains flexible customization tools, and can be implemented quickly and economically. The databases can be used to capture data from existing paper Case Report Forms or as paperless electronic data capture systems. Many Ofni Clinical projects require less than a month to go from project initiation to validated implementation. Contact us today and find out how to use Ofni Clinical for your clinical trials.
- Matches your existing Case Report Forms (CRFs), reducing training and implementation costs while adding electronic data capture and review capabilities.
- Automates the creation, review, and resolution of data queries.
- Allows for double-data entry and facilitates data cleaning and remediation.
- Includes extensive edit check and data validation features to identify questionable data entry and support data analysis.
- Is compliant with 21 CFR 11, Annex 11, and HIPAA requirements for electronic data security and management.
- Does not require special software or require annual license fees – the Sponsor owns the system and the data.
- Has an intuitive user interface which is easy to learn and administer.
Learn more about Ofni Clinical