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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![GettyImages-2148428939-computer-business-woman-office]( "Why RWD Strategy Can't Wait With Price, Value And Evidence Pressures Everywhere")
Why RWD Strategy Can't Wait With Price, Value And Evidence Pressures EverywhereOvercome pricing pressures and reimbursement delays by integrating real-world evidence early in development to align clinical outcomes with payer demands and accelerate patient access.
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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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2026 Clinical Trials: Strong Headwinds, Winds Of Change6/11/2026
Are your Phase I–III/IV clinical studies prepared for today's regulatory landscape? Learn how leading organizations are addressing compliance, transparency, and data ownership risks.
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2026 State Of Clinical Trial Technology: The Five Strategic Imperatives3/12/2026
AI acceleration and digital fragmentation are reshaping clinical trials. Discover five imperatives driving interoperability, smarter site enablement, and data‑ready workflows for future‑ready operations.
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Eliminate Clinical Trial White Space With The Right AI Strategy10/9/2025
Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
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Accelerate Drug Development With Master Protocols5/15/2025
Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Sponsors Can Leverage New Technologies To Lower Trial Costs1/6/2025
This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.
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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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Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.
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Setting A New Client Standard In Study Closeout Timelines4/4/2025
Learn how a top-10 global pharmaceutical company achieved a significantly faster time to market for a high-profile therapy.
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Use Of Epiontis ID In A Phase 2 Psoriasis Trial9/25/2025
Mirikizumab’s Phase 2 trial explores IL-23 inhibition in psoriasis, measuring immune cell changes to assess its potential for long-term disease control and flare-up prevention.
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Turning Rapid Study Start-Up Into Enrollment Momentum9/18/2026
A large Phase III ATTR-CM outcomes trial spanning 37 countries reached 50% enrollment eight months early, with monthly accrual rates running 3–5x above plan through coordinated cross-functional execution.
NEWSLETTER ARCHIVE
- 10.28.26 -- The U.S. Clinical Trial Recruiting Pipeline – September 2026
- 10.28.26 -- Feasibility Isn't Just A Technology Problem
- 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
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
