Ofni Clinical – System Details
Rapid Implementation and Deployment
Created by Ofni Systems, world leaders in electronic compliance and validation automation, Ofni Clinical can provide your organization with an electronic data collection solution for your clinical trials. Many databases can be created, implemented, and validated in a few weeks.
Electronic Clinical Report Forms
- Rapid Implementation – Create and validate a database for your clinical trial in days, not months!
- Matches Your CRFs – Ofni Clinical can be configured to match your existing CRFs, minimizing training and data entry costs.
- Great for Electronic Data Capture – Receive all of the benefits of electronic records by migrating from a paper-based system to an electronic one.
- Go Paperless! – Ofni Clinical supports paperless data collection and analysis, saving you the cost of printing, storing paper, and lost records while reducing your carbon footprint.
Ofni Clinical includes tools to manage your clinical trial data:
- Data Queries – Ofni Clinical automates generation and reporting of data querys, allowing you to address issues in data entry and data reconciliation.
- Edit Checks – Ofni Clinical facilitates data review, quickly identifying inconsistent or questionable data entry.
- Supports Double-Data Entry – Ofni Clinical includes Data Reconciliation Tools to compare and address inconsistencies in data entry.
Compliant with 21 CFR 11, Annex 11, and HIPAA
Ofni Clinical is fully technologically compliant with 21 CFR 11, Annex 11, and HIPAA to ensure data security, with such features as:
- Audit Trails track all data additions, edits, and deletions
- Event Logs record who accesses your data and when
- Electronic Signatures
- Authority Checks and User Level Security
- Configurable Password Strength and Expiration
- Program Time-Outs
Learn more about Ofni Clinical