Insights On Trial Design

  1. ICH E6(R3): 10 FAQ On What Changed And What It Means For Your Trials 9/18/2025

    The ICH E6(R3) updated guidelines present 10 critical changes to make clinical trials more efficient, adaptable, and patient-centric, while upholding the standards of scientific and ethical integrity.

  2. Reimagining Medical Monitoring In Clinical Research 4/11/2025

    Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.

  3. Meeting 100% Recruitment 7 Months Ahead Of Schedule 7/23/2024

    Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.

  4. Improving The Patient Experience In Clinical Research 2/6/2025

    To preserve the quality of care and build a more effective approach to trial design, a sponsor must consider their approach to patient recruitment and enrollment early and often.

  5. Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays 9/25/2025

    Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

  6. Early Phase Clinical Trial Enrollment: How To Avoid Delays From The Start 1/22/2026

    By operationalizing the early-phase strategies discussed in this article, trial teams can ensure that foundational safety and efficacy data are captured without the delays that derail studies.

  7. Early Oncology Clinical Trials: Key Considerations To Plan For Success 5/14/2025

    This presentation outlines the key success factors driving high-impact oncology drug development, with a focus on translating innovative science into clinically and commercially meaningful outcomes.

  8. DCTs For Older Adults: Mobile Research Trends And Recommendations 7/9/2024

    Learn how DCTs can be tailored to suit the needs of older adults, potentially transforming geriatric clinical research and addressing the unique challenges faced by this growing population.

  9. How To Streamline The Complexity Of Clinical Trials 1/30/2026

    Streamlining intricate end-to-end processes ensures that data moves with speed and security, converting the current landscape of logistical bottlenecks into a transparent, high-efficiency engine.

  10. Outlook Good For 7 Drugs Up For Q3 Review 8/15/2024

    A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.