Client Spotlight: MicroTransponder, Inc., Austin, TX

Client Spotlight: MicroTransponder, Inc., Austin, TX

MicroTransponder’s Paired VNS platform combines Vagus Nerve Stimulation (VNS) and therapy, with the goal of improving quality of life for patients with chronic neurological conditions. The recently FDA-approved Vivistim System designed to help patients regain their arm and hand motor function, several years after their stroke.

A longtime client of Simplified Clinical MicroTransponder needed a clinical data management partner for the long haul to obtain regulatory approval for its Vivistim, breakthrough technology to help improve upper limb function for stroke survivors.

Brent Tarver – Vice President, Clinical Affairs commented:

  • I’ve used Simplified Clinical since 2010 to develop and manage our electronic data capture system (EDC) on various study projects, including several pilot studies, one large pivotal study, and one very large registry that is still ongoing.
  • We work with SC up-front to assist with our forms development, data specifications and data collection. SC is also integral to our data monitoring and data query process; we also use them to assist with various data reports and downloads.
  • The Simplified Clinical EDC System is intuitive and therefore extremely easy-to-use. We don’t have to spend a lot of training time – either internally or externally – to use the system. However, we’ve used the system for all of our IDE and PMA submissions, including our Vivistim System PMA approval in 2021. So their system provides all the regulatory compliance and audit trails needed for FDA submissions.
  • The best part of our relationship with Simplified Clinical are the people. They are easy-to-work with, responsive, and friendly. When we need a fast response, answers, or updated work – we get it, no questions asked and no delays. Plus we get all of this with very reasonable pricing.
  • Simplified Clinical was suggested to me by a former colleague more than 15 years ago. I’ve used them ever since, with no thought of changing systems or companies. I highly recommend them for any study data collection needs.

Thanks, Brent. It has been a pleasure working with you and your team and helping to bring these life-changing technologies to patients in need. We look forward to supporting your efforts for years to come.

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