We expect pharmaceutical companies to have sizable profit margins, but we collectively scoff at research sites for achieving the same. Maria P. Ladd explores this difference in expectations and why it needs to change for the sake of the industry.
- Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)
- Project Management And AI: What Should Be Automated And What Should Not
- How Clinical Research Site Operating Models Perform in Practice – Part 2
- Why Operating Model Is The Next Competitive Frontier In Clinical Research Site Strategy – Part 1
- Before AI Can Transform Clinical Trials, It Needs More Patient Data
- CTTC Opens With A Reality Check On AI
- How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients
GUEST COLUMNISTS
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![Healthcare cybersecurity, data protection, digital health technology-GettyImages-2245958684]( "Before AI Can Transform Clinical Trials, It Needs More Patient Data")
Before AI Can Transform Clinical Trials, It Needs More Patient DataKing’s College London Professor Maddy Parsons says AI won't improve clinical trials — unless researchers begin collecting richer biological data, embracing diversity, and treating every clinical trial as learning opportunity.
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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
How One Researcher's Personal Study Experience Is Helping Him Better Serve PatientsRegeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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![Start to finish-GettyImages-1410756550]( "i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned")
i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They LearnedDiscover how well AI fared in document generation, patient engagement, data integration, and more in an end-to-end proof-of-concept study run by i-Cubed.
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![Woman in depression-GettyImages-2175026346]( "Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?")
Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?Pistoia Alliance's Thierry Escudier and Aditya Tyagi discuss how social media listening is used in clinical research, how it supports established evidence-generation methods, and how it can become a credible, structured input for drug development.
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![armpit lymph pain-GettyImages-1671734100]( "How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa")
How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis SuppurativaElisa Maggioli, Ph.D., explains that improving outcomes in HS may depend on moving beyond broad, symptom-based approaches toward more targeted, biologically informed strategies.
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![Calendar-GettyImages-2237279814]( "Unicycive Therapeutics' Framework For Speedier Clinical Trials")
Unicycive Therapeutics' Framework For Speedier Clinical TrialsUnicycive Therapeutics Vice President of R&D Guru Reddy, Ph.D., shares how his small team moved swiftly through a recent early phase trial.
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![consoling-GettyImages-2190851878]( "Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder")
Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive DisorderHelus Pharma CMO Amir Inamdar discusses the strategic rationale behind its Phase 3 trial for major depressive disorder, including its adjunctive-treatment approach, patient population selection, and endpoint strategy.
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![Medical innovation-GettyImages-1295854799]( "Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials")
Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical TrialsLearn from ex-FDA and ELIQUENT consultant Dawn Wydner, Ph.D.., how treating data integrity as an end-to-end clinical information flow issue, rather than a database-only concern, is essential to managing AI-related risk.
CLINICAL TRIAL WHITE PAPERS
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![People-modern-technology-connection-GettyImages-1081165980]( "Best Practices In Rare Disease Patient Recruitment")
Best Practices In Rare Disease Patient RecruitmentRecruiting for rare disease clinical trials is daunting, and making patients aware of clinical trials, involving them in trial design, and building trust are a few ways sponsors can boost recruitment.
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Go From Three Meetings To One With AI-Enabled eCOA5/5/2026
Learn how to turn three meetings into one with AI that is streamlining clinical workflows by reducing redundant steps, simplifying site operations, and accelerating data collection.
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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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2026 Annual Completed Clinical Trials Report: Strong Headwinds And 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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Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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DECODE CRS: Accelerating Immunotherapy Access And De-risking CRS6/18/2026
How does the DECODE CRS Coalition help trial sponsors standardize protocols and build a first-of-its-kind wearable dataset to lower development costs and safely de-risk outpatient care?
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Building A High-Quality IND From Scratch With Strategic Gap Analysis8/12/2025
A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).
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Relieving Pressure During Preparation Of A High-Volume sNDA5/27/2026
Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.
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Preparing The Next Generation Of Clinical Research Professionals9/4/2025
Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.
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3-Week Database Builds That Withstood FDA Review3/31/2026
Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.
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Streamlining Phase 1 Trials With The Mobile Vision Pod1/29/2025
A contract research organization formed a partnership to address significant challenges during a Phase 1 clinical trial for a corneal disease treatment through the use of a Mobile Vision Pod.
NEWSLETTER ARCHIVE
- 07.10.26 -- Accelerating Trial Execution With AI And Real-Time Data
- 07.09.26 -- Why "Steady Evolution" Best Describes AI's Future
- 07.09.26 -- Rewriting cancer… and patient recruitment
- 07.08.26 -- Accelerate Research: How AI, Master Protocols, And Better Recruitment Save Time
- 07.08.26 -- Why Australia Is A Strategic Launchpad For Early-Phase Studies
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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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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![Crowd, Sale, road, promotion-GettyImages-1320971995]( "AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them")
AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
FOCUS ON PATIENTS
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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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![pre-filled GLP-1 receptor agonist pens-GettyImages-2225780922]( "The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future")
The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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![Blue Print-GettyImages-172211936]( "A Blueprint For Addressing Underserved Patient Populations")
Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
