Ledidi + Franklyn Health: Accelerating Clinical Evidence

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.

Why Ledidi and Franklyn Health Have Joined Forces

Small and mid-size 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 are often underserved. The CROs and EDC platforms built for large pharma sponsors can be slow, rigid and priced beyond reach. Franklyn Health was founded to be the responsive, personally accountable CRO those companies deserve. Ledidi was built so sponsors can design studies in days rather than months and keep direct, real-time access to their own data. Together, we give innovators a single path from study design through to post-market follow-up, at a pace and cost that fits how smaller companies actually work.