MedTech’s Trusted Champion

Problem:

Sponsor had minimal US team presence and needed a strategic partner with strong, dual operations across EU and US

Outcome:

Successful partnership from FIH and CE Mark, and supporting the study design and FDA IDE submission for the IDE approved pivotal program

Problem:

AgNovos had several programs running in parallel throughout the globe across multiple use cases, with a hybrid executional strategy utilizing several CRO partners alongside a strong internal clinical development team

Outcome:

Avania and AgNovos worked through an efficient transition of activity to drive efficiencies in cost and study execution. The flexible model of service has been helpful in predicting cash flow for AgNovos as well

Problem:

Disperse datasets across device data, electronic patient reported outcome (ePRO) data, participant medication and pain diary data, in addition to a robust clinical dataset from follow-up visits at sites

Outcome:

Avania and Neuros held staged and iterative meetings post last patient in at the primary endpoint, partnered on study report strategy and writing, resulting in PMA approval without questions on the clinical module and absent an advisory committee meeting.

Problem:

Get to market in an expedited manner

Outcome:

FDA submission went in ahead of schedule

Problem:

Complex statistically analysis needed, with multiple sensitivity analyses

Outcome:

First of its kind, FDA-approved product supported by the statistical analysis of the prospective, randomized control trial