Frequently Asked Questions about Ofni Clinical

Q: Can you really implement Ofni Clinical in a few weeks?
A: Yes! We can create and validate a database based on your existing CRF in a few weeks and provide you with a turnkey solution for recording data for your clinical trial.

Q: Can Ofni Clinical create databases based on our paper CRFs?
A: Yes! Ofni Clinical can be configured to duplicate your existing paper CRF. By matching your CRF, Ofni Clinical minimizes training and data entry costs. This enables Ofni Clinical to be used as a true paperless electronic data capture system.

Q: Does Ofni Clinical charge a user fee or are there restrictions on the number of users?
A: Ofni Clinical does not charge a per-user fee, nor are there restrictions on the number of users that can use the database.

Q: Does Ofni Clinical require a continuing subscription fee?
A: No. Your clinical data is your own, and Ofni Systems would never charge you to access your own data.

Q: What are the Ofni Clinical system requirements?
A: Ofni Clinical requires:

Microsoft Office Professional 2003 (or later)

1 GHz (or faster) processor

512 MB (or more) RAM

1 GB (or more) free hard disk space

Q: Does Ofni Clinical run locally or from a shared drive?
A: Ofni Clinical can run from either a local drive or a shared network folder. Ofni Clinical was designed to require minimal IT support and assistance with installation and maintenance.

Q: Is there anything added to the registry or on the desktop of the client computer?
A: There is nothing about Ofni Clinical that needs to be referenced on the client machine, either in the registry or placed on a local drive.

Q: Our organization does not have any validation standards for Clinical Trial databases (we are a small startup) but we need them! Can you help us?
A: Yes. If you are starting a validation department, Ofni Systems can help you develop policies and procedures to validate all of your systems to ensure compliance with 21 CFR 11 and 314.

Q: How do I get started with Ofni Clinical?
A: Contact Ofni Systems and we will schedule a meeting to discuss an implementation plan for Ofni Clinical.

Learn more about Ofni Clinical