Discover how AI-enhanced point-of-care diagnostics are changing trial design and what ClinOps should do next.
- 'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint
- Sustainable Patient Engagement: Your Enrollment And Representation Depend On It
- The Big Idea Behind The Creation Of SIP
- Building The Execution Architecture For Real-World Data To Have Real-World Impact
- Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial
- The Reality Of Clinical Research Federal Funding Cuts
- Everyone Is A Consultant Now
GUEST COLUMNISTS
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The Reality Of Clinical Research Federal Funding Cuts
Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.
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Everyone Is A Consultant Now
Jon Newton argues clinical research’s “vanishing middle” is giving rise to a more flexible workforce of consultants, specialists, and boutique firms.
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Rare Disease Study Gets A Boost From Crowdsourced Patient Reported Data
Jen A. Levitt, MD, explains how crowdsourced patient-reported data and AI tools can compress rare disease research timelines and surface new signals.
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What The Sponsor–CRO Relationship Gets Wrong — On Both Sides
The CRO's value is not execution alone. It is the depth of perspective that comes from having seen hundreds of trials across disease areas and regulatory environments.
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The U.S. Clinical Trial Recruiting Pipeline Report – July 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 June through July 2026.
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The Art And Skill Of Caring For Terminally Ill Patients In Clinical Research And Beyond
When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.
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What The FDA's Latest Move On Psychedelics Means For Non-Hallucinogenic Drug Sponsors
Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.
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5 Signs Your Clinical Trial Needs Outside Help
Could you use some outside help? The right outside partner can bring the expertise, capacity, and perspective needed to get studies back on track.
CLINICAL TRIAL WHITE PAPERS
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A Practical Guide To Harnessing The Value Of APAC For Global Trial Success
As Phase III costs and complexity rise, APAC offers faster enrollment, lower costs, and market access advantages, but capturing that value requires early planning and in-region expertise.
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Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape9/1/2025
Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
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Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?10/20/2025
Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
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Completed Clinical Trials Continued To Climb In 20246/19/2025
Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
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Overcoming Issues Of Non-Enrolling Sites In Clinical Trials1/14/2025
Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.
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RWD, New Technologies Show Potential In Clinical Trial Recruitment7/10/2025
Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
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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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.
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How A Small Biotech Partnered With Us To Navigate Trial Complexity With Confidence And Control7/30/2026
Early-phase trials often evolve rapidly. See how a flexible RTSM approach helped a biotech sponsor manage major protocol changes without disrupting study execution.
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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How Expert Medical Information Support Strengthened A Rare Respiratory Therapy Launch5/26/2026
Embedded medical information expertise enabled compliant, real‑time scientific engagement with healthcare professionals at a high‑profile congress during a critical product launch.
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Solutions To The Challenges Of Oncology Trials5/6/2025
This significant Phase III trial, one of the largest global studies in head and neck cancer, faced considerable challenges including enrollment delays and an intricate study design.
NEWSLETTER ARCHIVE
- 08.24.26 -- Bridge The Gap Between Raw Data And Clinical Enrollment
- 08.21.26 -- Safeguarding Data Integrity And Exploring Agentic AI
- 08.21.26 -- From Oncology To Neuro-Science: Flexible CRO Support Built For Every Trial
- Take Another Angle To The FDA Focus On Psychedelic Research
- 08.19.26 -- Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
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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Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
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When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.
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Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
FOCUS ON PATIENTS
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Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
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Imbria Pharmaceuticals' Albert Kim, MD, Ph.D., shares why PROs are the point of the company's FORTITUDE-HCM trial for patients with non-obstructive hypertrophic cardiomyopathy.
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When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.