Ofni Clinical

Ofni Clinical is a clinical data management tool provided by Ofni Systems. According to the vendor, it is designed to facilitate the creation, validation, and implementation of 21 CFR 11 compliant clinical trial databases. The product is suitable for companies of all sizes, including small startups and large clinical organizations. It is commonly used by professionals and industries such as pharmaceutical companies, contract research organizations (CROs), biotechnology companies, medical device manufacturers, and academic research institutions to efficiently collect, manage, and analyze data from clinical trials.

Key Features

Electronic Case Report Forms: Ofni Clinical allows for the creation of customizable electronic case report forms (CRFs) that streamline data capture from clinical trials. According to the vendor, this eliminates the need for manual data transcription and reduces the risk of errors.

Edit Checks: Ofni Clinical includes extensive edit check features that identify inconsistent or questionable data entry. According to the vendor, these checks can be customized to meet specific data validation requirements, improving data quality and supporting efficient analysis.

Medwatch Form 3500A Support: Ofni Clinical supports the Medwatch Form 3500A, simplifying the reporting of adverse events and product problems to the FDA. The vendor claims that the system provides a user-friendly interface for completing and submitting the Medwatch Form 3500A, ensuring compliance with regulatory requirements and facilitating timely reporting.

Efficient Data Entry and Review: With electronic CRFs, Ofni Clinical enables efficient data entry and review, eliminating the need for paper forms. According to the vendor, this paperless data capture provides the benefits of electronic records while reducing costs associated with printing and storing forms.

Comprehensive Support and Guidance: Ofni Systems offers comprehensive support and guidance to help organizations get started with Ofni Clinical. According to the vendor, they review existing Case Report Forms (CRFs), schedule requirements, and propose a database that matches the existing CRFs and meets the organization's timeline. The product is said to have an intuitive user interface, making it easy to learn and administer with minimal IT support required for installation and maintenance.

Customizable Data Validation: Ofni Clinical's edit check features can be customized to match specific data validation requirements. According to the vendor, this facilitates data review and cleaning, ensuring the accuracy and integrity of the collected data and supporting efficient data analysis.

FDA Compliance Assistance: Ofni Systems provides customer support to help organizations meet FDA, ICH, and GCP data requirements. According to the vendor, they can assist with compliance reviews and auditing to ensure regulatory compliance and help organizations become compliant if any gaps are identified.

Streamlined Adverse Event Reporting: Ofni Clinical supports the Medwatch Form 3500A, simplifying the reporting of adverse events and product problems to the FDA. The vendor claims that the user-friendly interface streamlines the reporting process, ensuring compliance with regulatory requirements and facilitating timely reporting.

Intuitive User Interface: Ofni Clinical offers an intuitive user interface, according to the vendor, making it easy to learn and administer. They state that minimal IT support is required for installation and maintenance.

Validation Services: Ofni Systems offers validation services, including the production of executed validation packages for databases and other systems. According to the vendor, this ensures the validation and compliance of the clinical trial data management system.