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Frequently Asked Questions about Ofni ClinicalTM
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These are the most 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.

Q: Does Ofni Clinical charge a User fee or are there restrictions on the number of users?
A: Ofni Clinical does not charge 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 Office Professional version 2000 (or higher). Ofni Clinical also requires 128 MB of RAM.

Q: Does Ofni Clinical run locally or from a shared drive?
A: Ofni Clinical can run from either a C-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 820.

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.

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