Paul Komenda M.D., MHA, FRCPC, FASN

Chief Medical Officer
Quanta Dialysis Technologies Limited

We interviewed a number of CROs before we selected Avania to help us conduct our medical device IDE trial. From inception to execution and closeout, we were continuously impressed with the team’s diverse skill set, responsiveness, and willingness to pitch in whenever required. The team is experienced and well credentialed, but we were most impressed at how whatever we asked, the Avania team delivered without any pushback. These trials are complex, often frustrating, and there are many ups and downs. I would trust Avania in a heartbeat for getting things over the line, on time, and on budget.”

Patrick Balsmann

Unity HA Director Regulatory
Clinical & QA

As a regulatory/clinical/quality scientist, I am not a linguistics expert best equipped to define all the adjectives (superlative, outstanding, etc.) that come to mind from working with Avania. What I can say is that Avania rocks! Avania has assembled an expert team, assisting me in our efforts to bring to market a medical device that had IDE clinical data and regulatory submissions from a previous manufacturer. From providing gap analyses, preparing IDE reports, and planning pre-submissions for getting our product across the finish line, Avania is proving to be invaluable in these efforts. Working for an orthopedic surgeon can be highly demanding and Avania is right there for every one of my inquiries — their responsiveness has made this a thoroughly enjoyable work effort. I look forward to working with Avania on the completion of this project and many more in the future.”

Doug Vincent

President and CEO – Design Mentor

As an early stage, MedTech startup, you are only as strong as your next round of funding. And no three letters give an investor more pause than “FDA.” Fortunately, months of collaboration with Avania helped produce a very successful Pre-Submission meeting, the results of which have become the cornerstone of our future fundraising efforts. Throughout the process, we have been pleased with not only Avania’s regulatory strengths, but also their understanding of the powerful stresses startups face. Bottom line: Avania has become a critical strategic partner in helping prepare the VentriFlo® True Pulse Pump for successful market clearance so we can fulfill our mission of providing improved healthcare options to some of the sickest cardiac patients while helping achieve lower overall total costs.”

Dustin Arless

Clinical Development at SoundBite Medical Solutions Inc.

Avania shows a passion for supporting companies as they develop their technologies to make an impact on healthcare and the marketplace. Avania has a deep pool of experience for developing effective and efficient regulatory strategy, clinical strategy, and protocol writing, as well as networking with KOLs. Avania understands the needs of a fast-paced young and growing start up, and provides their services in a courteous, supportive, and patient manner.”

Burke T. Barrett

Vice President of Regulatory & Clinical Affairs at CardioFocus

Our recent PMA submission and approval took eight months from filing to approval. We worked with Avania as a statistical consultant throughout the development and execution of the HeartLight pivotal clinical study. Avania delivered high-quality statistical services throughout the study and PMA process. We are very appreciative of their valuable statistical insights.”

Jim Dibiasi

3D Communications, LLC

While collaborating with Avania to prepare our mutual client for a successful FDA PMA Panel meeting, I was able to see first hand the quality of Avania. I have thoroughly enjoyed working with the Avania team. They provide an unparalleled level of dedication and service to their clients.”

Jason Connor, Ph.D.

Statistical Scientist

Avania understands the benefits of the Bayesian adaptive approach to clinical trial design. While partnering with Avania to provide adaptive clinical trial designs, I have seen how Avania provides thoughtful and aggressive strategic advice to its clients. Avania is dedicated to helping its clients using innovative and accurate statistical designs and analysis plans in line with current FDA guidance and the FDA’s critical path initiative.”

Your product is important, and your trial deserves the team that has what it takes. It takes knowledge. It takes passion. It takes commitment. It Takes Avania.

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