Ofni Clinical

Key Benefits of Ofni Clinical

• Rapid Implementation – Create and validate a database for your clinical trial in days, not months!
• Matches Your Case Report Forms – 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 electronic data.
• Data Queries – Ofni Clinical automates generation and reporting of data queries, allowing you to address issues in data entry.
• 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.
• Fast User Training – Minimal training is needed for data entry users, database administrators, and IT administration. Data entry users can be trained in minutes. Database administration is also easy to learn, and IT administration does not require any special training.
• Easy to Install, Implement, and Maintain – Ofni Clinical has minimal IT requirements and can be run from a desk top, network file location, or server. Ofni Clinical supports MS Access and SQL Server.

World Class Service and Support

Ofni Systems has been providing world class software and support to large and small companies for more than 10 years.

• Complete Customer Support – Ofni Systems professionals want to work with you to ensure that your clinical trial meets and exceeds all FDA, ICH, and GCP data requirements.
• Compliance Reviews and Auditing – Ofni Systems can ensure that your organization meets regulatory requirements and can help you become compliant if a gap is identified.
• Validation – We can produce an executed validation package for your clinical trial database or other systems in days, not months.
• Assistance with Data Entry and Data Reconciliation – Ofni Systems can assist with converting your paper records to electronic data and reconciling any issues in data entry.

Our goal is to ensure that your clinical trial exceeds all requirements for clinical trials.

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

• List of Key Features, including:
  • Electronic Case Report Forms
  • Edit Checks
  • Medwatch Form 3500A
• Getting Started with Ofni Clinical
• Service and Support
• Read the Ofni Clinical Frequently Asked Questions
• See how Ofni Clinical Benefits your Company