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BLOG

Blogrobgjryan2026-05-04T14:40:28+00:00
  • Blog, EDC

    What a VP of Clinical Operations Should Ask a CRO About Biomarker Trial Readiness

    Evaluating a CRO for a biomarker-driven oncology trial? Use these questions on site selection, central lab coordination, EDC design, and screening failure management.

    Continue reading
  • Blog, RTSM

    RTSM Requirements for Adaptive Oncology Trials: What Your System Must Be Able to Do

    In an adaptive oncology trial, the RTSM must do four things that a conventional randomization system is not required to do: enforce configurable cohort and dose assignment rules in real [...]

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  • Blog

    How to Design Central Lab Workflows for Precision Oncology Trials

    Central lab workflow design determines enrollment velocity in precision oncology. Learn how to structure turnaround SLAs, result notification, and re-biopsy processes.

    Continue reading
  • Blog, RTSM

    Why Biomarker Screening Delays Kill Oncology Enrollment — and How to Prevent Them

    Biomarker-driven oncology trials enroll slowly because eligibility depends on a chain of steps — tissue procurement, sample shipment, lab processing, result communication, and site decision — each owned by a [...]

    Continue reading
  • Blog, RTSM

    The Operational Discipline Behind a Successful Adaptive Oncology Trial

    Adaptive oncology trials fail operationally, not statistically. Learn what data readiness, RTSM configuration, and DSMB preparation actually require in execution.

    Continue reading
  • Blog, RTSM

    Umbrella Trial Supply Management: What Sponsors Get Wrong

    Drug supply management in an umbrella trial requires RTSM configuration that explicitly models arm expansion and arm closure scenarios — not supply planning for the initial design with manual adjustments [...]

    Continue reading
  • Blog, EDC, RTSM

    How to Prepare Your Data for Adaptive Trial Interim Analysis

    Data readiness for adaptive trial interim analysis is an operational problem solved months before the window arrives. Here's what must be true before your DSMB can decide.

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  • Blog, IRB

    The Operational Infrastructure Required to Run a Basket Trial

    Running a basket trial operationally requires infrastructure that treats each tumor type cohort as a distinct operational unit within a shared governance framework: cohort-specific site selection (not study-level), a central [...]

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  • Blog, IRB

    How to Structure Governance for a Basket or Umbrella Trial

    A well-governed basket or umbrella trial requires four explicitly designed governance bodies: a Steering Committee with defined decision authority over major protocol changes, an IDMC chartered specifically for adaptive review [...]

    Continue reading
  • Blog, eConsent

    What an ICF Is Today & What It Must Become Tomorrow

    Learn what an Informed Consent Form is, why it protects research participants, and how AI, and global regulations are reshaping the future of consent.

    Continue reading
  • Blog, IRB

    From Exploitation to Ethics: The History of Human Subjects Research

    Explore the history of human subjects research, from unethical experimentation to modern protections like IRBs, the Belmont Report, and global research ethics.

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  • Blog, CTMS, eConsent, EDC, Payments, RTSM

    Moving Beyond Disconnected Systems into a Unified Clinical Trial Data Ecosystem

    The future of clinical trials is a unified, interoperable ecosystem. Sitero’s Mentor platform is leading this transformation, ensuring that clinical trials are more efficient, compliant, and streamlined than ever before. Learn more in our latest blog:

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