INSIGHTS ON CLINICAL TRIAL DESIGN

• Designing Successful Cell And Gene Therapy Trials

  Designing cell and gene therapy trials requires specialized strategies to navigate unique complexities, ensuring successful and compliant development.

• Building Trust Through Connection: EmVenio At The Atlanta Black Expo

  Engaging with communities in familiar settings helps raise awareness, address concerns, and create a more inclusive foundation for clinical research participation built on dialogue, respect, and long‑term relationships.

• Hybrid Ophthalmic Trials: Splitting Visits Across Home, Hub, And Site

  Hybrid ophthalmic trials combine in-person and remote visits, boosting patient convenience, reducing site burden, and accelerating timelines while maintaining data quality and compliance.

• CNS Trials Are Difficult — Do They Have To Be?

  Clinical trials for central nervous system therapies face significant obstacles to approval, including subjective endpoints and complex patient selection. Consider a strategic approach for success.

• FDA Draft Guidance On Diversity Action Plan Requirements

  10/24/2024

  Explore new drafted guidance under FDORA that substantiates the mandate of a Diversity Action Plan (DAP) for late-stage trial protocol submissions.

• Embedding AI And Critical IRB Operations Data To Drive Intelligent Study Design

  1/28/2026

  Explore how modern clinical trial design is being transformed by a rich array of data sources through this clear roadmap for navigating the evolving complexities of the industry.

• Why Ophthalmology Assessments Are Non-Negotiable

  1/22/2025

  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.

• The Perfect Solution For Recruitment, Retention, And ROI

  8/15/2024

  See how Citeline Connect was deployed to advance enrollment six months ahead of schedule for a sponsor’s Phase IV atopic dermatitis trial and build a community of engaged patients.

• Ensuring A Diverse Patient Population In Clinical Trials

  12/13/2024

  In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.