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.
- 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
- Rare Disease Study Gets A Boost From Crowdsourced Patient Reported Data
- What The Sponsor–CRO Relationship Gets Wrong — On Both Sides
- The U.S. Clinical Trial Recruiting Pipeline Report – July 2026
GUEST COLUMNISTS
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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.
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What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development
Complementing an interview with Enveric Bioscience's Joseph Tucker, Ph.D., this Q&A explores Josh Hardman's thoughts on what FDA’s psychedelic focus could mean for classic psychedelic development.
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The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment
Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
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How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy
Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.
CLINICAL TRIAL WHITE PAPERS
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Five Preventable Clinical Design Pitfalls And How To Avoid Them
While late-stage trial attrition is often attributed to inadequate safety or efficacy, the true failure may be insufficient upstream planning and/or misalignment between clinical and commercial goals.
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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.
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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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Challenges And New Approaches To Developing Clinical Evidence For Medical Devices9/12/2024
Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.
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Real-World Value Realized From DHTs In Clinical Trials10/22/2024
Explore four real-world examples of clinical trials that successfully integrated DHTs. Each case study highlights how DHTs impacted specific aspects of trial design.
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Proving The Return On Investment For eRegulatory1/22/2025
Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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Advancing Oncology Innovation With Adaptive Trial Designs8/12/2025
When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.
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Supporting Study Set Up In Just 4 To 6 Weeks3/4/2025
Facing challenges in cycle times, quality control, and visibility, a global CRO adopted Medidata’s Rave Imaging, integrating it with its existing Rave EDC system to create a seamless digital workflow.
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Inspection Facilitation Without Local MAH Presence5/26/2026
Local expertise and centralized oversight ensured compliant, well‑coordinated inspections across countries, reducing operational risk and client burden while maintaining consistent authority engagement.
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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication1/29/2025
This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
NEWSLETTER ARCHIVE
- 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
- 08.19.26 -- What Every Clinical Leader Should Know About AI, Safety & Compliance
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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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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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.