Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
- FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors
- Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials
- 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?
GUEST COLUMNISTS
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![CTD story - GettyImages-1253880092 and Canva]( "How Did You End Up In Clinical Research?")
How Did You End Up In Clinical Research?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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![Collaboration, growth in business-GettyImages-2216095959]( "From CRO Management To Networked Governance: The New Quality Imperative")
From CRO Management To Networked Governance: The New Quality ImperativeThe clinical research industry once emphasized transactional vendor management, but now it requires broader governance to enable the level of quality that enables scalability and success.
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![Focus on FDA-GettyImages-2229675668]( "Will FDA's One-Day Inspection Pilot Stand The Test Of Time?")
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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![risk-GettyImages-1419222683]( "QA Transitions Don't Create Inspection Risk — They Reveal It")
QA Transitions Don't Create Inspection Risk — They Reveal ItConsultant 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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![AI contract 1 (2)]( "Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)")
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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![AI contract 1]( "Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)")
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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![AI contract-GettyImages-2207503201]( "Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)")
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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![Mother abd adult daughter at doctors-GettyImages-2213748134]( "Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study")
Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS StudyBeing time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1165981632_hands_caregiver]( "Radiation Therapy Quality Assurance In Clinical Trials")
Radiation Therapy Quality Assurance In Clinical TrialsHere, the authors describe the crucial role of radiation therapy in oncology trials and how a robust quality management program can enhance treatment outcomes and research efficacy.
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Overcoming Challenges In Obesity Trials2/12/2026
Obesity trials face high dropout rates due to long durations and complex requirements. Overcome these hurdles with personalized engagement, expert lifestyle support, and proactive patient care.
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Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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US Healthcare System Overview4/29/2026
A clear guide to U.S. coverage, regulation, and reimbursement: who decides care, how products gain access, and how policy and financing shape cost, value, and patient access.
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Rewriting The Future Of Clinical Trials8/8/2025
In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development
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4 New Approvals In Q3 Across Gene, Cell, RNA Therapies11/13/2025
Q3 2025 brought notable progress across the gene, cell, and RNA therapy landscape, marked by four new global approvals. While regulatory progress continued, clinical development activity slowed.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Reducing The Burden Of Patient Retention And Improving Continuity1/6/2026
Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
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Phase 1 Trial In Painful Diabetic Peripheral Neuropathy2/24/2026
A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
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Sleep Assessment In Sleep Disorders3/16/2026
Discover how continuous, objective monitoring in a home environment captures sleep improvements that traditional lab-based snapshots often miss, ensuring more accurate clinical outcomes.
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Medable Platform Delivers >90% eCOA Adherence And Scalability7/8/2024
Discover how eCOA use drove >90% adherence across an extensive weight management master protocol clinical trial with multiple sub-studies across 70+ research sites.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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How To Seamlessly Integrate NetSuite With Power BI8/12/2024
Unlock the power of your NetSuite data with seamless integration to Power BI. Learn how to automate data refresh, gain real-time insights, and make informed business decisions.
NEWSLETTER ARCHIVE
- 05.28.26 -- Prepare For 2026 With Systems That Scale With Every Stage Of Growth
- 05.27.26 -- Why Clinical And Commercial Development Must Be Integrated Fully And Early
- 05.27.26 -- STREAM Edition: Think Big, Start Small With AI
- 05.26.26 -- Human-In-The-Loop In AI Validation And Control
- 05.22.26 -- Reimagine Data Governance For The AI Era
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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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
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![IRB ad approval-Getty image 1075404882]( "Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation")
Should informed consent really start with clinical trials ads? And if not, why do IRBs need to be involved in their approval? Paul Ivisin unravels the tangled web of IRBs, regulators, and clinical trial advertisements.
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![CTD story - GettyImages-1253880092 and Canva]( "How Did You End Up In Clinical Research?")
To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"
FOCUS ON PATIENTS
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![Mother abd adult daughter at doctors-GettyImages-2213748134]( "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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![build trust-GettyImages-1175873327]( "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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![prescription instructions-GettyImages-1785706494]( "Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It")
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.
