Key Takeaways

  • NAMSA and Lexitas have formed a strategic partnership to deliver fully integrated, end-to-end development support for ophthalmic medical device sponsors under a single contract
  • The collaboration embeds Lexitas’ ophthalmic clinical experts and 700+ site network into NAMSA’s global MedTech platform, creating a unified operating model with shared systems and accountability
  • Sponsors benefit from streamlined execution, specialized ophthalmic expertise, global reach, and reduced vendor complexity across the entire product lifecycle

NAMSA, a provider of MedTech contract research and end-to-end development services, announced a strategic partnership with Lexitas Pharma Services, a full-service ophthalmology contract research organization (CRO). The collaboration is designed to provide comprehensive product development support to ophthalmic medical device sponsors, addressing growing demand for specialized expertise across the full development lifecycle.

The partnership combines Lexitas’ ophthalmic focus with NAMSA’s global medical device development platform. Lexitas contributes an investigator site network of more than 700 locations, an integrated reading center, and specialized clinical expertise. NAMSA brings experience in device development, regulatory strategy, and global CRO operations. Together, the companies aim to create a unified, end-to-end solution for device innovators, the companies announced in a news release.

Unlike traditional CRO partnerships that rely on referrals or subcontracting, NAMSA and Lexitas will function as a single, integrated team. Lexitas’ clinical experts, including medical monitors, ophthalmic imaging specialists, and site strategy leaders, will be embedded directly within NAMSA’s project and study management framework. The companies will operate under a shared technology infrastructure, standardized processes, and a unified quality management system. This model is intended to give sponsors a streamlined experience, with a single point of accountability and consistent oversight across all stages of development.

Through the partnership, ophthalmic device sponsors will gain access to:

  • End-to-end development support, from preclinical research and biocompatibility testing through Investigational Device Exemption (IDE), pivotal trials, regulatory submission, and commercialization
  • Specialized ophthalmic clinical execution supported by Lexitas’ extensive site network, integrated reading center, BCVA certification program, and dedicated medical monitoring team
  • Device-focused clinical expertise, including FDA endpoint strategy and device-specific trial design
  • Broad therapeutic coverage across anterior and posterior segment indications, including advanced modalities such as cell and gene therapies and treatments for rare diseases
  • Global operational reach spanning the United States, Europe, and Asia-Pacific
  • A single-contract model that reduces vendor complexity and coordination risks

“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. This partnership with Lexitas allows us to offer exactly that,” said Brian Smith, Chief Executive Officer of NAMSA. “Together, we’re giving sponsors a rare combination — world-class device development under one contract, with the ophthalmic specialization to execute at the highest level.”

NAMSA and Lexitas will be onsite together at the ARVO annual meeting, taking place May 3–6 in Denver, Colorado. Ophthalmic device sponsors and industry partners are invited to visit the Lexitas booth #10032 to connect with the joint team.