preclinical white papers and articles

  1. The Role Of Oncology Biomarkers In Personalizing Hematology Treatment Plans 6/18/2026

    Oncology biomarkers guide personalized treatment and help track disease changes. Learn more about how advancements like liquid biopsies improve precision care.

  2. Making Informed Decisions In Your Oncology Study: Understanding Biomarkers 6/18/2026

    Oncology biomarkers track tumor burden and reduce radiation from imaging. Composite algorithms improve response prediction. Fit-for-purpose strategies are needed to manage logistics and costs.

  3. Measuring What Can't Be Seen: How PTSD Clinical Trials Prove A Drug Works 5/22/2026

    PTSD trials expose one of the hardest problems in modern drug development, a reliance on clinician-administered and patient-reported scales to determine whether a therapy truly works.

  4. The Impact Of Expert PK/PD Modeling In Psychedelic Research 12/2/2025

    Model-informed development that integrates preclinical and literature-based data is enabling smarter predictions of exposure and safety, transforming psychedelic research and advancing clinical innovation.

  5. Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows 9/2/2025

    Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.

  6. Why Bioanalysis Needs To Break Free From Manual Bottlenecks 9/2/2025

    Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.

  7. Strategic CMC Considerations For Pre-IND Meetings: Setting The Stage For A Successful TPP 9/1/2025

    In biotechnology, the Pre-Investigational New Drug (Pre-IND) stage is a critical juncture. Explore the pivotal role of Chemistry, Manufacturing, and Controls (CMC) in navigating this phase.

  8. Enhancing The Biosimilar Review Process 8/12/2025

    The biosimilar market is projected to reach over $100 billion in the next five years. Learn how to navigate the expanding landscape and overcome challenges in accessing key clinical information.

  9. Maximizing Early-Phase Trials Of CNS-Active Drugs 7/9/2025

    Understand how specialized assessments and early-phase clinical strategies can generate meaningful safety, pharmacology, and proof-of-concept data.

  10. Continuing Your Research Mission -- Even As Budgets Tighten 5/12/2025

    Amid growing uncertainty in clinical research funding, including proposed budget cuts from the NIH that threaten indirect support for essential infrastructure, OpenClinica remains a steadfast partner to researchers.