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Clinical Trial Case Studies 5
CASE STUDY: PHASE 1 SAFETY ASSESSMENTS

Enhancing Phase 1 Clinical Trials with Point-of-Need Safety Assessments

Syneos Health, a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success, encountered an obstacle during a Phase 1 study. The study protocol required monitoring for potential ocular side effects, but the clinic lacked the specialized equipment and personnel to conduct comprehensive eye exams.

Clinical Trial Case Studies Mobile Vision Pod MVP
CASE STUDY: CORNEAL DISEASE TREATMENT

Streamlining Phase 1 Trials with the Mobile Vision Pod

Company Z, a CRO specializing in early-phase drug development, encountered challenges during a Phase 1 study for a corneal disease treatment. The study required eye assessments at specific time points, but low patient volume and scheduling constraints made it difficult to engage local ophthalmologists. Additionally, the clinic lacked space for onsite eye assessments.

Clinical Trial Case Studies 1
CASE STUDY: RESPIRATORY TREATMENT

Optimizing Non-Ophthalmic Phase 3 Trials with Point-of-Need Eye Assessments

During the chronic cough study, mandated by the FDA, Company W had to incorporate an ocular substudy to monitor eye health. The primary issue was that the selected study sites, specializing in respiratory treatments, lacked the resources for ocular assessments. This led to challenges, including pushback from the sites and difficulties in coordinating with local ophthalmologists.

Clinical Trial Case Studies 4
CASE STUDY: CYSTIC FIBROSIS MEDICATION FOR PEDIATRIC PATIENTS

Expanding Access to Post-Market Safety Exams with Point-of-Need Care

Company Y, a biopharmaceutical company specializing in treatments for serious diseases, faced a challenge in ensuring access to essential eye exams for pediatric patients taking its cystic fibrosis (CF) medication. Long wait times for appointments, limited Medicaid acceptance, and the vulnerability of immunocompromised patients posed significant barriers to care.

Clinical Trial Case Studies 2
CASE STUDY: GENE THERAPY FOR RARE DISEASES

Advancing Rare Disease Clinical Trials with Point-of-Need Eye Assessments

Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology company, faced significant challenges during the COVID-19 pandemic and subsequent SKYLINE trial enrollment for X-linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM) gene therapy treatments. Travel restrictions and site limitations hindered patient participation and threatened trial progress.

20/20 Onsite Clinical Trial Case Study
CASE STUDY: OVERCOMING OBSTACLES IN A PHASE 1 STUDY

Streamlining a Clinical Study for Syneos Health

When Syneos Health faced an unexpected obstacle in a Phase 1 clinical trial, they knew they needed a fast, reliable solution backed by experience. Patients were already being transported for 45 minutes from the Phase 1 site to the ophthalmology clinic, and then an essential piece of equipment at that vendor ophthalmology site broke, stalling the entire trial. Syneos Health and the sponsor needed a solution to help move the study forward and increase patient satisfaction by reducing travel time and scheduling frustrations. Syneos Health turned to 20/20 Onsite for help.

2020 Onsite Clinical Trial Solutions Case Study ADA
CASE STUDY: DIABETIC SCREENING

Expanding Diabetes-Related Eye Health Equity with the American Diabetes Association® and Genentech

Diabetes is a leading cause of vision loss, yet many individuals at risk lack access to essential eye care services. 95% of diabetes-related eye diseases are preventable with early detection, timely treatment, and follow-up care. However, logistical barriers such as geographic location, lack of awareness, and limited access to specialized care disproportionately impact underserved communities.