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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The Complexities Of Effective Patient Retention In Clinical Trials
Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.
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What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?1/28/2025
Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.
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Potential Of eClinical Solutions To The Complexity Of Oncology Trials7/31/2025
How are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.
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Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology4/11/2025
Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.
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Implications Of Assessing Overall Survival In Oncology Studies3/25/2026
New oncology standards mandate pre-specified survival analysis to catch long-term harm. Learn how to implement hazard ratio thresholds and the ICH E9(R1) framework for global compliance.
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Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expand Bandwidth With A Trusted Regulatory Writing Partner9/18/2025
Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
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Castor Services8/6/2026
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Trial Rescue And Reconnaissance4/15/2026
Explore a strategic partnership that resulted in a rescue plan for a Phase III oncology trial that was facing high site decline rates.
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts10/17/2025
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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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.
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.