Insights On Trial Design

  1. Make GCP Training Easier For Sites Before Meetings 7/23/2026

    Completing GCP training before investigators’ meetings reduces compliance work, aligns site expectations, and frees meeting time for protocol planning and study startup preparation.

  2. Breaking Through Barriers With Integrated Trial Optimization 5/9/2025

    In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.

  3. Anthropic's Stainless Acquisition: What It Means For Clinical Trials 6/5/2026

    As AI models become interchangeable, value is shifting to the orchestration layer that connects tools, workflows, and governance—making flexibility, interoperability, and auditability critical.

  4. Leveraging Biomarkers In Early PK/PD Studies 7/9/2025

    Integrating biomarkers into early clinical studies is crucial to determine whether a new therapy engages its biological target, triggers the intended PD effects, and shows early signs of efficacy.

  5. Expectations For Plain Language Summaries Continue To Evolve 11/7/2025

    Plain language summaries (PLS) are growing in importance as a requirement in global transparency. Focusing on protocol and results summaries, we cover expectations and best practices for global PLS implementation.

  6. DCTs And Community-Based Research Execution And Compliance 5/28/2025

    The FDA's regulatory endorsement of DCTs enhances their credibility, offering a pathway to more inclusive and accessible clinical research that benefits both patients and sponsors.

  7. Sleep Assessment In Sleep Disorders 3/16/2026

    Discover how continuous, objective monitoring in a home environment captures sleep improvements that traditional lab-based snapshots often miss, ensuring more accurate clinical outcomes.

  8. Why Data Integrity Still Matters — Even As Clinical Trials Evolve 12/4/2025

    Data integrity remains essential for compliance and patient safety. Learn strategies to maintain accuracy and reliability as clinical research evolves toward more connected, technology-driven models.

  9. 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.

  10. Clinical Trials Need To Take The Whole Patient Into Account 7/10/2025

    Explore how inclusivity in clinical trials needs to encompass the whole patient, taking into account factors like race, sex, age, ethnicity, sexual orientation, and physical abilities or qualities.