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

Lexitas Pharma Services' headquarters in Durham, NC, United States

This department oversees the planning, execution, and management of clinical data to ensure accuracy and compliance in clinical trials.

Clinical Data Management

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

The Project Management team at Lexitas Pharma Services is responsible for overseeing and coordinating all aspects of clinical trials related to ophthalmic drug development. This includes managing timelines, budgets, resources, and communication channels to ensure that projects progress smoothly from initiation to completion. They work closely with other departments to align study designs, regulatory strategies, and data management processes, ensuring that each project meets the unique requirements and high standards associated with ophthalmic therapies.

Project Management

This department focuses on planning, conducting, and managing clinical trials and research studies to evaluate new treatments and medical interventions.

Clinical Research

This department focuses on identifying new business opportunities and fostering relationships to drive growth.

Business Development

The Clinical and Medical Writing team at Lexitas Pharma Services specializes in the creation and development of high-quality regulatory and scientific documents. They are responsible for drafting protocols, clinical study reports, investigator brochures, and submission-ready documents for INDs and NDAs. Their work ensures clear, precise, and compliant communication of clinical trial data and regulatory information, supporting the seamless progression of innovative ophthalmic therapies from concept to patient care.

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People (3)

Jobs (0)

Other teams

Clinical Operations

Project Management

Clinical Research

Business Development

Clinical and Medical Writing

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People (3)

Jobs (0)

Other teams

Clinical Operations

Project Management

Clinical Research

Business Development

Clinical and Medical Writing

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