Are you ready to submit your IND/IDE application to the FDA?

Take our self-assessment and find out now

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Question Title

* Have you assessed all U.S. FDA approval pathways for your product?

Yes, I've done thorough research and know which apply to my study

I've looked at a couple of them but I’m not sure if they fit my product

I'm not aware of FDA approval pathways

Question Title

* What does it mean to use clinical trial optimization?

It’s the inclusion of advanced statistical parameters.

It’s finding the minimal number of studies needed for market approval

I have heard of optimization, but I don’t know what it means.

I don’t know what clinical trial optimization is

Question Title

* Do you know how adaptive trial designs can be applied to your Phase II and/or Phase III trial?

Yes, I have used these designs previously and adaptations for this trial are defined

Yes, I know what adaptive designs are, but I have not applied them to this trial

No, I don’t know what adaptive designs are and I don’t know how to use them

Question Title

* Do you know the risks of using adaptive designs in your specific trial?

Yes, we have identified specific risks to be aware of throughout the trial

No, I don’t know anything about risks associated with adaptive designs

Unsure, I know there are risks but I haven’t reviewed them regarding my trial

Question Title

* Have you consulted with an expert statistician to discuss adapting your trial or applying other statistically nuanced parameters?

Yes

Question Title

* Do you know if you need a pre-IND/IDE meeting with the U.S. FDA before preparing your IND/IDE application?

Yes

Unsure

Question Title

* Do you understand how to initiate and use a proof-of-concept trial?

Yes

Unsure

Question Title

* Have you considered pre-clinical testing requirements that can be done in parallel with your Phase II and/or Phase III trial?

Yes

I'm not familiar with parallel processing

Question Title

* Have you begun study start-up activities, such as identifying qualified sites, building the database, designing the data entry platform, and/or programming tables and listings for statistical analysis?

Yes and all start-up activities are a go

I've begun some, but not all start-up activities

I have not

Question Title

* Have you assessed the advantages of using foreign clinical data for FDA approvals?

Yes, I've assessed using foreign clinical data

I'm unsure if I can use foreign data

No, I have not considered it

Question Title

* Ready to see your results?

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Are you ready to submit your IND/IDE application to the FDA?Take our self-assessment and find out now

Question Title

* Have you assessed all U.S. FDA approval pathways for your product?

Question Title

* What does it mean to use clinical trial optimization?

Question Title

* Do you know how adaptive trial designs can be applied to your Phase II and/or Phase III trial?

Question Title

* Do you know the risks of using adaptive designs in your specific trial?

Question Title

* Have you consulted with an expert statistician to discuss adapting your trial or applying other statistically nuanced parameters?

Question Title

* Do you know if you need a pre-IND/IDE meeting with the U.S. FDA before preparing your IND/IDE application?

Question Title

* Do you understand how to initiate and use a proof-of-concept trial?

Question Title

* Have you considered pre-clinical testing requirements that can be done in parallel with your Phase II and/or Phase III trial?

Question Title

* Have you begun study start-up activities, such as identifying qualified sites, building the database, designing the data entry platform, and/or programming tables and listings for statistical analysis?

Question Title

* Have you assessed the advantages of using foreign clinical data for FDA approvals?

Question Title

* Ready to see your results?

Are you ready to submit your IND/IDE application to the FDA?

Take our self-assessment and find out now