NAMSA and Lexitas Form Strategic CRO Partnership for Ophthalmic Medical Device Development

• NAMSA, a global MedTech CRO, and Lexitas Pharma Services, a full-service ophthalmology CRO, have announced a strategic partnership to deliver end-to-end development services for ophthalmic medical device sponsors under a single contract and unified operating model.

• The partnership embeds Lexitas’ ophthalmic clinical expertise — including a 700+ investigator site network and integrated reading center — directly into NAMSA’s development platform under a unified operating model and quality management system.

NAMSA has announced a strategic partnership with Lexitas Pharma Services to deliver comprehensive ophthalmic medical device development services under a single contract and unified CRO operating model. The collaboration brings together NAMSA’s end-to-end MedTech development platform with Lexitas’ specialized ophthalmology clinical capabilities, giving device sponsors a single accountable partner across the full product lifecycle.

Unlike traditional referral or subcontracting arrangements, the two organizations will operate as one integrated team. Lexitas clinical experts — including medical monitors, ophthalmic imaging specialists, and site strategy leads — will be embedded directly within NAMSA’s project and study management structure, operating under shared technology, processes, and a single quality management system. Sponsors receive one team, one set of accountabilities, and coordinated oversight from preclinical and biocompatibility through IDE, pivotal trial, regulatory submission, and commercialization.

Lexitas brings over 15 years of dedicated ophthalmic expertise to the partnership, along with a network of more than 700 investigator sites, an integrated reading center, a BCVA certification program, and a dedicated medical monitoring team. Combined with NAMSA’s device-native regulatory expertise — including FDA medical device endpoint fluency and IDE strategy — the model is designed to address an outsourcing gap in a therapeutic area where sponsors have historically managed separate vendors for device development and ophthalmic clinical execution.

The partnership extends across anterior and posterior segment indications, including cell and gene therapy, rare disease, and advanced modalities, with global coverage spanning the U.S., Europe, and Asia-Pacific. NAMSA serves over 3,000 MedTech companies worldwide and has more than 1,500 experts across its network.

“Ophthalmic device sponsors have asked us for something the market hasn’t been able to deliver in a coordinated way: deep device-specific expertise across the full development lifecycle, paired with specialized ophthalmic clinical execution.”

Brian Smith, Chief Executive Officer, NAMSA

NAMSA and Lexitas will present the partnership jointly at the ARVO Annual Meeting on May 3–6, 2026, in Denver, Colorado, at Lexitas booth #10032.