Small and mid-size medical device and diagnostics companies are the engine of innovation in healthcare. But when it comes to generating the clinical evidence they need to reach patients, they're often underserved. The CROs and EDC platforms built for large pharma sponsors can be slow, rigid, and priced beyond reach.
These companies deserve better. That's the shared conviction behind our new partnership with Franklyn Health.
Franklyn Health is a full-service CRO built specifically for small and mid-size device and diagnostics manufacturers. The team brings decades of experience from both sides of the sponsor–CRO relationship, and founded Franklyn with a single ambition: to be the CRO they always wished existed — responsive, consistent, and personally accountable.
At Ledidi, we built our clinical evidence platform around a simple belief: sponsors deserve direct, real-time access to their own data. Study design shouldn't require a six-month implementation cycle. And the evidence you generate should stay yours — portable, reusable, never locked inside someone else's system.
Our no-code platform is validated for GCP and FDA 21 CFR Part 11 compliance, with ISO 27001 and SOC 2 Type II certification.
Together, we give device and diagnostics companies a single, joined-up path from study design through to post-market follow-up — without unnecessary complexity or overhead. Sponsors retain ownership of their data and study designs throughout. Outsourcing expertise shouldn't mean outsourcing control.
“We are delighted to announce our partnership with Franklyn Health. Their approach reflects a shared conviction — that clinical studies need not be slow, overly complex or prohibitively expensive, particularly for small and mid-sized MedTech companies. This is precisely the challenge Ledidi was built to address. Together, we are able to help organisations conduct high-quality studies more efficiently and at significantly reduced cost, regardless of geography. This partnership represents an important step in our mission to make compliant, efficient clinical evidence generation accessible to innovators across international markets”
— Einar Martin Aandahl, CEO of Ledidi
“Small and mid-size medtech companies deserve the very best. With Ledidi, we’re making sure they have the systems and support to bring life-changing technologies to patients worldwide”
— Rob Bedford, CEO of Franklyn Health
