Complimentary PRO GAP Analysis

Can you demonstrate how your targeted concepts are linked to your desired label claims?

Not sure about the requirements for migrating a paper PRO instrument to electronic format?

Concerned that your documentation related to the development of your PRO Instrument might not meet regulatory scrutiny?

In light of the FDA’s final Guidance to Industry on PROs in Clinical Development (Dec. 2009), many biopharmaceutical researchers are facing these and other, similar questions regarding their use of PROs in their clinical research.

PRO Consulting can help you find the answers you are looking for.

We are offering a free 60-minute PRO Gap Analysis with you and your team.  This is an opportunity to speak with a Senior PRO Consulting Scientist to assess what will be expected of your PRO instrument from a regulatory standpoint.  We will also discuss with your team what reasonable steps you can take to reduce risks and ensure the success of your PRO-based clinical development program.

To request a PRO Gap analysis, please fill out the form below and a member of our team will contact you to schedule the call.