Articles | Lexitas

Why Expertise in Ophthalmic Clinical Trials Matters for Medical and Protocol Writing

Why Expertise in Ophthalmic Clinical Trials Matters for Medical and Protocol Writing By Silke Thode In the complex and specialized world of ophthalmology clinical trials, the importance of precise and expert medical writing cannot be overstated. Medical writing is a discipline that demands not only a thorough understanding of the scientific content but also an […]

Lexitas CEO Jeanne Hecht On Trends And Challenges In Ophthalmology Clinical Trials

Lexitas recently welcomed our new CEO Jeanne Hecht, who has spent her career in leadership and board positions at top healthcare companies. As an industry executive for over 20 years, Jeanne has witnessed massive change in the healthcare industry at large – and is especially excited about the immense opportunities in ophthalmology. She shares her […]

Using AI in the Development of New Ophthalmic Treatment

The following is a transcript of a Q&A interview on the use of AI in ophthalmology clinical trials. What are the specific opportunities and benefits of artificial intelligence (AI) in clinical trials? In recent years, the big shift that we’re seeing in clinical trials is that the typical way to think about clinical trials was […]

Speeding Ophthalmic Trial Execution with an In-House Reading Center

Why working with an in-house reading center is crucial to ophthalmic trial successBy: Brittany Chung, Sr. Manager, Reading Center While external reading centers are commonplace in most ophthalmology trials, for many companies, these services can drive up costs and threaten critical timelines. Outsourcing to external centers no longer works given the highly competitive and resource-constrained […]

Development In Virtual Reality Testing As A Standardized Clinical End Point (via Modern Retina)

Development in virtual reality (VR) headsets creates a possibility that VR mobility assessments could become standard for clinical trial efficacy end points. See more from Drs. Winston Posvar, Andrew D. Pucker, and George Magrath in Modern Retina See More Our In Focus newsletter is published once a month and has thousands of subscribers. To help you keep in touch, you can subscribe here.

Dr. Sally Tucker On The Evolution Of Ophthalmic Trials

We are delighted to introduce Sally Tucker as the President of Lexitas Global Services, where she will be responsible for steering the continued development and expansion of our existing capabilities outside of the United States. We chatted with Sally about her role, her vision, and what practical advice she has for sponsors looking to run […]

CFS: It’s a Numbers Game – The Evolution of the NEI Corneal Sodium Fluorescein Staining Scale

Drs. George Magrath and Andrew Pucker describe the evolution of the NEI corneal fluorescein staining scale and why Lexitas developed an updated version that can help companies achieve better endpoints. See More Our In Focus newsletter is published once a month and has thousands of subscribers. To help you keep in touch, you can subscribe here.

Achieving Repeatability in Staining with a Modified NEI Scale

Corneal fluorescein staining, which assesses the rate and process of healing, is one of the most important components of dry eye studies. Yet despite providing such a crucial trial endpoint, staining is difficult to measure consistently – we’re still figuring out the best way to guarantee reproducibility across PIs, visits, and sites. Over the years, […]

Shawn Scranton, PharmD., on Revolutionizing the Treatment of Ophthalmic Diseases

We recently had the pleasure of sitting down with Shawn Scranton, PharmD., President and CSO at Amber Ophthalmics, a clinical-stage biotech company dedicated to addressing unmet ophthalmic medical needs. Their groundbreaking work aims to restore, preserve, and improve the vision and quality of life of patients. We delve into their innovative drug, Nexagon® (lufepirsen ophthalmic […]

Lanita Scott, M.D. – Maximizing the Likelihood of Success for Your Ophthalmology Studies

Dr. Lanita Scott recently joined Lexitas Pharma Services as Sr. Vice President of Medical and Clinical Sciences. We sat down with Lanita to learn more about key issues in the industry and her plans for Lexitas. Welcome to Lexitas, Lanita! You have extensive experience in various clinical and medical positions at companies such as Adverum, […]

A Modified NEI Grading Scale for Corneal Fluorescein Staining w/ Dr. Ken Sall

A Modified NEI Grading Scale for Corneal Fluorescein Staining Dr. Ken Sall and Dr. Andrew Pucker discuss why a new, modified NEI grading scale for corneal fluorescein staining shows efficacy when the original scale does not. Dr. Sall explains the history of cornea grading, the common methodologies for grading and the advantage of the new […]

Our Plans to Help Bring More Ophthalmic Treatments to Patients

It’s well known that almost 50% of Phase 3 trials do not meet enrollment criteria, and that almost 80% of all trials are delayed due to patient recruitment and retention problems*. This is an on-going challenge that the life sciences industry has struggled with for many years. At Lexitas, we believe there must be a […]

Improving Patient Retention in Ophthalmology Clinical Trials

Improving Patient Retention in Ophthalmology Clinical Trials has a major impact on the success of ophthalmology studies, and it’s only getting more challenging to recruit and retain trial participants. For clinical trials overall, studies have shown that 100 potential candidates must be identified for every 9 subjects who will ultimately be enrolled, and only 7 […]

Joanna Williams – Ophthalmology Clinical Trials Predictions for 2023

What’s Happening In Ophthalmology Clinical Trials – Predictions For 2023 Preparedness and adaptability are critical to the success of ophthalmology clinical trials. Our four-part “Predictions For 2023” series aims to give you a glimpse of what will likely happen in the coming year, and how you can be better prepared. Clinical Operations. By Joanna Williams, […]

AI Helps Identify Patients Likely to Respond to Treatment During Ophthalmology Clinical Trials

Transcript Hello, my name is George Magrath and I’m the CEO at Lexitas Pharma Services. I’m also an ophthalmologist. And I’d like to talk to you today about the way we’re using machine learning and artificial intelligence in clinical trial work that we do in particular dry AMD but also in other indications as well. […]

How Diversity, Equity and Inclusion in Clinical Trials Leads to Better Health Outcomes

Almost 20% of new therapeutics have demonstrated differences in exposure and/or response across racial and ethnic groups, according to a study by the American Society for Clinical Pharmacology and Therapeutics.[1] In some cases, this even leads to different prescribing recommendations for specific populations and can have a real-world impact on health outcomes. This is one […]

All Under One Roof

Dec 05, 2020 – 2020 has been a challenging year. There has been a lot of uncertainty, misinformation, and fear. We have, like most of you, been operating in a mostly-virtual existence since March to limit the spread of COVID-19. Heading into the fall with cases and hospitalization rising, our virtual work-life shows no sign […]

Operationalizing an Ophthalmology Protocol

You know what you want your study to look like. You have probably done your homework and know what your competitors have tried, what the regulators are expecting/requiring, and you’ve confirmed that you are aligned with current medical practice and any applicable treatment guidelines. You may even have some key opinion leaders on your speed […]

The Hidden Value of Onsite Monitoring

October 18, 2017 – Ellie Einolhayat, RN, a Lexitas monitor (clinical research associate) provides insight on the role onsite monitors have in identifying issues with protocol design and other challenges that come with successfully executing a clinical trial. To learn about this and more, please read the attached article published in the August 2017 edition […]

Lexitas Monitors – Focused on Details and the Big Picture

If you are in the clinical research business (and presumably you are if you’re reading this!), you understand the role of a clinical research associate (CRA), commonly referred to as a monitor. The primary function of a CRA is to follow Good Clinical Practice to ensure the investigative site’s compliance to the protocol and adherence […]

Choosing a CRO – Avoiding the Trap of Commoditization

We have all embarked on a weekend getaway to a new and exciting destination. The whole process becomes something of a project, and part of the fun is trying to figure out where to eat dinner. You could consult an online travel guide and hit the number one attraction. Although dining at the famous restaurant […]

One Size Fits None – Internal Focus at the Expense of Customer Relationships

By now everyone has heard about the 69-year-old passenger who was forcibly removed from a United Airlines flight, suffering a stunning set of injuries including a concussion, a broken nose, and the loss of two front teeth. Most of us probably have seen enough of the coverage to have learned the reason behind all of […]