FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
- What Happens When Clinical Trial Patients Need Care Outside Of The Study?
- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
- Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source
- Who Owns Your Clinical Trial Software When The Vendor Leaves?
- What The New PDUFA Guidance Means For Drug Development
- The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings
- Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care
GUEST COLUMNISTS
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![Diverse women doctors-GettyImages-2246070483]( "The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings")
The Site Landscape Is Evolving, But How? Tufts CSDD Shares New FindingsTufts CSDD data reveals how academic, independent, and network-affiliated clinical trial sites differ in growth, reach, staffing, and performance.
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![Patient ultrasound examination-GettyImages-1473904792]( "Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care")
Testing Early Treatment In Head And Neck Cancer Without Compromising Curative CareCan early APG-157 treatment control head and neck cancer without delaying curative care? A Phase 3 trial puts timing, safety, and outcomes to the test.
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![new reg part 1 - GettyImages-1366013071]( "The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?")
The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?Part one of this two-part series explores how clinical trial regulation aims to balance speed, quality, compliance, and digital innovation.
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![new reg part 2 - GettyImages-1366013071]( "Get Ready For Regulators With This Speed-Quality-Compliance Framework")
Get Ready For Regulators With This Speed-Quality-Compliance FrameworkPart two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations.
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![psychology, counseling-GettyImages-2274786993]( "Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?")
Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?Psychedelic-assisted treatment may offer faster, lasting relief for cancer patients facing adjustment disorder, depression, and anxiety.
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![Lab Experiment-GettyImages-157697835]( "The U.S. Clinical Trial Recruiting Pipeline – September 2026")
The U.S. Clinical Trial Recruiting Pipeline – September 2026This 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 August to September.
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![cyber security sign-GettyImages-1070773010]( "Unlocking AI Value For Clinical Research Associates")
Unlocking AI Value For Clinical Research AssociatesClinical research associates (CRAs) have largely been late to adopt AI. CRAs who adopt it can streamline repetitive work while also freeing capacity for high-judgment work.
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![Exclamation Symbol Blocks with Computer Mouse-GettyImages-2268428175]( "Your EDC Query Count Is Trying To Tell You Something")
Your EDC Query Count Is Trying To Tell You SomethingA rising EDC query count may reveal more than dirty data. Learn how query patterns can expose upstream problems in trial workflows, training, and CRF design.
CLINICAL TRIAL WHITE PAPERS
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![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Disclosure Management System: Build Or Buy?")
Disclosure Management System: Build Or Buy?Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
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A Guide To Digital Endpoints In Major Depressive Disorder3/7/2025
The integration of digital health technologies (DHTs) in clinical trials for Major Depressive Disorder (MDD) is transforming how symptom severity and treatment efficacy are measured.
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Phase-Appropriate Signal Detection In Clinical Trials10/5/2026
Are your trial safety methods right for your phase? Learn a framework that keeps medical judgment central, avoids overreading sparse early data and catches rarer risks as studies grow.
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Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials11/21/2025
This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies.
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Digital Twins: From Protocol Design to Predictive Study Execution9/14/2026
A growing generation of AI-enabled digital twin approaches offers a new path. Instead of treating the protocol as a static document, organizations can model it as a dynamic system.
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Beyond Automation: Transforming Clinical Trial Delivery Through Structured Information10/23/2026
Study build delays stem less from slow tasks than from protocol intent being reinterpreted at every handoff. Treating the protocol as structured, reusable information changes where AI and expertise belong.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Drilling Down On Diversity And Feasibility12/8/2025
A mid-sized contract research organization (CRO) sought help with writing clinical trial diversity action plans and assessing feasibility for therapeutic areas outside its usual scope.
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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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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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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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Supporting Participants Through National Travel Disruptions12/10/2025
A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.
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Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling3/12/2026
See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.
NEWSLETTER ARCHIVE
- 10.27.26 -- Sponsors Choosing Trial Tech Are Overlooking Important Factors
- 10.27.26 -- Helping Sponsors Advance Transparency And Regulatory Compliance
- 10.26.26 -- Participant Payment — Make It Make Cents
- 10.23.26 -- How One Sponsor Rescued A Trial Mid-Study — Plus 6 Steps To AI-Ready Data
- 10.22.26 -- From Psychedelics To Rare Disease: Navigating Regulatory Hurdles
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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![patient and doctor analyzing medical report-GettyImages-1461330630]( "Can A Universal Health Screening Help Stop Clinical Trial Dropouts?")
Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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![Medicine, healthcare insurance-GettyImages-1369119541]( "Participant Payment — Make It Make Cents")
Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.
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![Mature student Studying-GettyImages-1460342076]( "Most Patients Learn About A Trial Online, But Is That What They Want?")
Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
FOCUS ON PATIENTS
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![Doctor using tablet in hospital-GettyImages-2227564671]( "What Happens When Clinical Trial Patients Need Care Outside Of The Study?")
Clinical trial patients may need care outside of the trial protocol. Discover how closing information gaps can protect safety, trial participation, and data integrity.
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![Patient ultrasound examination-GettyImages-1473904792]( "Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care")
Can early APG-157 treatment control head and neck cancer without delaying curative care? A Phase 3 trial puts timing, safety, and outcomes to the test.
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![psychology, counseling-GettyImages-2274786993]( "Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?")
Psychedelic-assisted treatment may offer faster, lasting relief for cancer patients facing adjustment disorder, depression, and anxiety.
EDITORIAL COLLECTIONS
Take a deep dive into the issues shaping clinical research today with our curated Editorial Collections. Each collection features expert insights and practical strategies addressing today’s biggest challenges in clinical trial planning and execution.
More Editorial Collections
