Key Benefits of Ofni Clinical

• Rapid Implementation - Create and validate a database for your clinical trial in days, not months!
• Matches Your CRF - Ofni Clinical can be configured to match your existing CRF, 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 data.
• Data Queries - Ofni Clinical automates generation and reporting of Data Querys, 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.
• Supports CDISC/CDASH Standards
• 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, SQL Server and Oracle.

World Class Service and Support

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

• Complete Customer Support - Ofni Systems professionals want to work with you to ensure that your clinical trial meets and exceeds all Clinical Trial requirements.
• Compliance Reviews and Auditing - Ofni Systems can ensure that your organization meets all regulatory requirements and help you become compliant if a gap is identified.
• Validation - We can produce an executed validation package for your database 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 and when users access your data
• 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