Downloads

  1. Transforming European Case Intake Operations 5/26/2026

    Centralized intake and semi‑automation brought clarity and control to European safety reporting, improving oversight, data quality, and compliance across multiple partners and countries.

  2. From First Click to Randomization: Improving Patient Qualification in Psychiatry Trials 5/26/2026

    How can you, as a sponsor, optimize recruitment workflows, enhance patient screening, and ensure sites receive higher-quality patients?

  3. FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors 5/26/2026

    Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.

  4. Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials 5/26/2026

    BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.

  5. Faster Starts, Stronger Finish: Operational Excellence In NSCLC 5/22/2026

    In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.

  6. How Adaptive Design Accelerates Early‑Phase NSCLC Development 5/22/2026

    Adaptive trial designs and an adaptive mindset enable non-small cell lung cancer (NSCLC) sponsors to optimize dose, respond to evolving expectations, and accelerate early‑phase development.

  7. Data-Driven Strategies To Advance Development And Approval Of Rare/Ultra-Rare Disease Therapies 5/22/2026

    Explore how integrated regulatory, statistical, and operational expertise can be applied to help sponsors navigate complex development pathways and accelerate global approvals.

  8. Synaptic Regeneration And The Future Of Alzheimer's R&D 5/22/2026

    For too long, treating Alzheimer’s disease has been a case of “managed decline.” We need to move beyond slowing disease progression toward achieving tangible functional recovery.

  9. FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control 5/22/2026

    ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

  10. The Stakeholder Impact of Centralized Trial Services 5/21/2026

    Real‑world experiences show how centralizing logistics and payments streamlines coordination, reduces site burden, and improves trial execution.