Wearable data is easy to collect but difficult to turn into trusted RWE. Explore five fixes for the most common data problems when using wearables in research.
- 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
- Founders, Fortitude, And Clinical Trials
GUEST COLUMNISTS
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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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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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Get Ready For Regulators With This Speed-Quality-Compliance Framework
Part 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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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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The U.S. Clinical Trial Recruiting Pipeline – September 2026
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 August to September.
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Unlocking AI Value For Clinical Research Associates
Clinical 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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Your EDC Query Count Is Trying To Tell You Something
A 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.
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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?
CLINICAL TRIAL WHITE PAPERS
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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
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Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
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Five Integration Pillars To Redefine Frontline Patient Engagement And Safety Operations8/20/2026
Siloed medical information, patient support, product quality, and pharmacovigilance functions, alongside increasing biopharmaceutical complexity, require a unified operating model to meet modern demand.
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Biopharma Reaping Numerous Benefits From AI2/18/2026
Multiple AI use cases with significant impact have been identified, and they are expected to drive innovations in clinical trials, precision medicine, and commercial operations.
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Modernizing Clinical Trial Logistics To Deliver Value2/3/2026
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Turning Urgency Into Progress And Advancing New Hope In AML9/22/2026
A disrupted AML trial stabilized mid-study, cutting genetic testing turnaround to 1–2 days and keeping enrollment on track for patients who can't wait.
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Tailored Approach Supports Bladder Cancer Breakthrough3/5/2026
Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.
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Executing A Complex Global Breast Cancer Trial In A Rapidly Evolving Treatment Landscape9/14/2026
See how rapid site activation, strong oncology site relationships, and adaptive protocol management kept a complex global cancer trial on track amid evolving standards of care.
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FDA Fast-Tracked Clinical Trial7/9/2026
Deconstruct the enrollment bottleneck in an ophthalmic gene therapy trial, discovering how point-of-need pre-screening cuts site activation delays and accelerates clinical development timelines.
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Breaking Down Operational And Financial Complexity In Clinical Trials12/8/2025
Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.
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Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder5/27/2026
Global approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.
NEWSLETTER ARCHIVE
- 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
- 10.22.26 -- [For Biotech] Build Smarter Oncology Trials
- 10.21.26 -- Choose Your Approach: Traditional, Hybrid Or Decentralized
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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Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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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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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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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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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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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
