Clinical Guest Contributors

  1. GCP Oversight Simplified: A Quick Guide 9/29/2025

    Discover practical, real-world strategies for sponsors to operationalize GCP oversight in a way that is collaborative, measurable, and scalable.

  2. Powering Standards With Code: The Role Of Open Source In CDISC 360i 9/26/2025

    Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

  3. Site-Level Change Model And Successful Strategies For Medicare Compliance In Clinical Trials 9/26/2025

    Discover best practices for achieving and maintaining Medicare billing compliance for clinical trials.

  4. What The FDA Says About Investigator Responsibilities In DCTs 9/25/2025

    Learn exactly what the FDA says about the use of healthcare providers (HCPs), telemedicine, licensing, and practice standard requirements when executing a DCT.

  5. How Skipping The CRO Helped RenovoRx Get Closer To Patients 9/24/2025

    RenovoRx Chief Clinical Officer Leesa Gentry explains why they decided to forgo a CRO partner.

  6. When "Imperfect" AI Models Still Add Value In Pharma Quality 9/24/2025

    AI isn't perfect, and that's OK, says ERA Science's Andy O'Connor. Here, he contends that if we can prove and explain how a human+AI process outperforms a human-only process, then imperfection is still progress.

  7. 3 Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial 9/23/2025

    Discover how non-profit partnerships, adaptive trial design, and real-world evidence can all play a part in helping biotech's successfully launch their first-in-human trial.

  8. New FDA Program Adds Flexibility For Ultra-Rare Disease Submissions 9/23/2025

    Life science legal experts Mark A. Tobolowsky and Frank J. Sasinowski discuss the FDA's new Rare Disease Evidence Principles (RDEP) initiative.

  9. Why Research Professionals Should Enroll In At Least One Clinical Trial 9/23/2025

    Consultant and former director of the HHS Office for Human Research Protections (OHRP) Molly Klote, MD, implores clinical research professionals to enroll in a clinical trial to help them become more empathetic researchers.

  10. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

    Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.