I attended the inaugural Clinical Trials Technology Congress in London expecting to hear plenty about AI, digital tools, and the future of clinical trials. What stood out instead was how many speakers focused on a much more immediate issue: reducing complexity for sites, patients, and study teams.
- Synaptic Regeneration And The Future Of Alzheimer's R&D
- FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control
- Judgement-Based Project Management Builds Partners' Trust
- Can Independent Pharmacies Succeed Where Walgreens Failed?
- How Did You End Up In Clinical Research?
- From CRO Management To Networked Governance: The New Quality Imperative
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
GUEST COLUMNISTS
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Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
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QA Transitions Don't Create Inspection Risk — They Reveal It
Consultant Wijdan Suliman, MD, MHA, explains how QA leadership changes can reveal risks, including differences in the interpretation, lost historical context, and more.
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Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)
Leibowitz Law shares the third installment of its three-part series on contracting for AI in clinical trial operations. Part 3 picks up with cybersecurity, monitoring and validation, and risk allocation.
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Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)
Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 2 demonstrates why organizations must understand where it is used, how it interacts with data, and where the risks lie.
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Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)
Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.
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Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study
Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
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It's A Fact: Sharing Clinical Trial Results With Participants Builds Trust
CISCRP experts share results from their annual Perceptions & Insights Study showing that patients continue to place a high value on receiving both individual and overall study results.
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When AI Agents Start Researching Trials On Behalf Of Patients, What Happens?
Right now, patients are using AI agents to find clinical trials. But soon enough, these AI tools will be doing it on their own and feeding patients the results. Recruitment expert Ross Jackson discusses this shift and what it will mean for sponsors.
CLINICAL TRIAL WHITE PAPERS
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Wearables For Optical Cardiovascular Monitoring
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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State Of Clinical Trial Technology: The AI Inflection Point2/12/2026
Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.
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The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More3/25/2026
High-end technology cannot fix poor rater preparation or complex patient needs. True data integrity requires bridging the gap between digital platforms and the reality of clinical implementation.
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Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
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The Future Of Regulatory Operations6/3/2024
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
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Why Life Science Organizations Need A Chief Patient Officer Function4/27/2026
Bridging the gap between innovation and impact, this exploration of the Chief Patient Officer role offers a strategic framework to integrate patient insights and de-risk the product lifecycle.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays9/25/2025
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.
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Optimized Processes: A Guide To Lyophilization Cycle Development6/25/2024
Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.
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Relieving The Strain Of Publishing During Regulatory Registration8/7/2024
Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.
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Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech10/2/2025
This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.
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Targeted Indication Selection Using Adaptive Design8/12/2025
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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Biotech Delivers A Superior Patient And Site Experience3/4/2025
To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
NEWSLETTER ARCHIVE
- 05.26.26 -- Human-In-The-Loop In AI Validation And Control
- 05.22.26 -- Reimagine Data Governance For The AI Era
- 05.22.26 -- CROs Helping Emerging Biotechs And Drug Developers
- 05.21.26 -- The U.S. Clinical Trial Recruiting Pipeline Report – May 2026
- 05.20.26 -- The Legal Consequences Of AI In Clinical Research
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
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To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"
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Right now, patients are using AI agents to find clinical trials. But soon enough, these AI tools will be doing it on their own and feeding patients the results. Recruitment expert Ross Jackson discusses this shift and what it will mean for sponsors.
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This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from March 7 to May 1, 2026.
FOCUS ON PATIENTS
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Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
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CISCRP experts share results from their annual Perceptions & Insights Study showing that patients continue to place a high value on receiving both individual and overall study results.
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Standard methods for evaluating clinical trial representativeness perform poorly when the trial population differs from the broader disease population in a patient registry. June Cha, Ph.D., MPH, explains how the right metrics can make a difference.