INSIGHTS ON CELL & GENE CLINICAL TRIALS

• Why Ophthalmology Assessments Are Non-Negotiable

  Learn about the challenges researchers face when incorporating ophthalmology assessments into clinical trials, and how you can address those obstacles to the benefit of your trial and its participants.

• Linking Neurology And Ophthalmology For Clinical Trials

  Learn more about the innovative approach being taken to incorporate ophthalmology into neurology and central nervous system (CNS) research.

• Advancing Clinical Research In 2025: Meeting FDA Standards In Decentralized Trials

  Explore the key components of new FDA guidance on DCTs, including a focus on participant-centric designs and the use of Mobile Research Units (MRUs) to overcome geographic and technological barriers.

• Mid-Study Data Migrations: The Antidote To Longer Clinical Trials

  As trial durations continue to grow, mid-study migrations are transforming from rare occurrences into a critical strategy for maintaining efficiency and data integrity in clinical research.

• How Technology Helps Clinical Trial Sites And Their Staff

  eConsent is transforming clinical research sites by addressing key pain points and streamlining processes for overburdened staff.

• The Key To Clinical Trial Success In 2025

  As the landscape of clinical trials continues to evolve, point-of-need care and the integration of mobile clinics present a scalable approach to improve retention, compliance, and patient satisfaction.

• Optimizing The Channel Strategy To Expand Patient Access

  Patient access depends on a well-planned channel strategy. Explore key considerations for optimizing distribution, logistics, and patient support in the evolving cell and gene therapy landscape.

• Successful Regulatory Submission Via The Trifecta Of Awesomeness

  Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

• Optimizing Non-Ophthalmic Phase 3 Trials With Point-Of-Need Eye Assessments

  Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties

• Five Key Ways Sponsors And CROs Can Optimize Ophthalmic Clinical Trials

  By embracing point-of-need models and strategic collaborations, sponsors and CROs can streamline ophthalmic trials and maximize ROI while advancing sight-saving therapies.