Solutions

Early-Stage Startups

Early-Stage Startups

Syntactx gives early-stage startups the advantage they need to realize their goals. Our dedicated team of experts will work with you to plan and execute your clinical and regulatory vision that supports your corporate strategy and investor expectations while also respecting your budget and timeline. Your designated project manager will be your partner throughout the process who is committed to facilitating a transparent relationship and ensuring you’re always kept up to speed.

We understand that the stakes are high. We can help you at each stage of the clinical evidence generation journey to prime your game-changing technology for commercialization.

Our experience

Our team knows that the foundation of a successful clinical program starts with a solid clinical and regulatory strategy. Whether you are preparing for a a first-in-human study or planning to bring your first device to market, you can be confident in our ability to give your innovative products the best chance of success.

  • Partnered with small European companies with no US presence to plan, source, and execute their US IDE trials
  • Reconfigured early feasibility data for a vascular device start-up to help the FDA better understand it, leading to FDA approval for their IDE
  • Helped several European and Canadian clients successfully received for 510(k) clearance
  • Established a 510(k) pathway and ultimate clinical pathway for a cancer-specific indication for an early-stage oncology device

Leadership

David Ouriel worked as a strategic advisor to early stage life sciences firms.

SyncronyTM

Discover Syncrony, our next generation EDC. Syncrony is a cutting-edge tool that combines data capture, reporting, analytics, and statistics, and has been proven to increase the accuracy in collecting, tracking, and storing clinical trial data.

Discover how Syncrony can support you.