From dream to drug, we are the only ophthalmic-focused, people-centric and purpose-driven product development partner, helping innovative life sciences companies bring new vision therapies to patients. We pair world-class ophthalmology clinical expertise with years of experience partnering with highly-regarded eye care investigators. Our site management strategies are tailored to the unique requirements of each study, resulting in a track record of stellar performance and exemplary customer satisfaction. You can count on us from IND all the way through NDA.

We have extensive experience in posterior and anterior segments, as well as rare diseases.
 
Service Offerings:
-Regulatory strategy
-Study design and protocol development
-Endpoint evaluation and selection
-Site selection, management and training
-Clinical project management and monitoring
-Medical monitoring
-Data management & Biostatistics
-Reading center
-Medical Affairs & commercialization strategies

Clinical Trials

Life Sciences

Pharmaceutical

Lexitas Pharma Services

Amanda Castellon

Amy Brown

Dan Cormican

Donna Sedoti

Jen Kratz

Ryan Kaiser

Sowmya Reddy

Katie Thorson (Romans)

Roshma Modupalli

Polly Sizemore

Tony Proctor

Lanita Scott M.d.

The Clinical Operations team at Lexitas Pharma Services is dedicated to the execution and oversight of clinical trials for ophthalmic therapies. This team manages study design, protocol development, site selection, and training, ensures compliance with regulatory requirements, and oversees clinical project and data management. Their role is crucial in ensuring that trials run smoothly, data is accurately collected and analyzed, and the investigational therapies meet safety and efficacy standards, ultimately supporting the journey from IND submission through NDA approval.

Clinical Operations

Project Management

Clinical and Medical Writing

Clinical Operations

About

Team members

Other teams at Lexitas Pharma Services

Project Management

Clinical and Medical Writing