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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![clinical-compliance-GettyImages-2259718661]( "10 Clinical Research Practices That Feel Like Compliance (But Aren't)")
10 Clinical Research Practices That Feel Like Compliance (But Aren't)Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
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Navigating IDMP Through The Extended EudraVigilance Medicinal Product Dictionary8/7/2024
Here, the authors explain why adherence to evolving requirements is essential for marketing-authorization holders (MAHs) to ensure compliance and maintain accurate product information.
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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.
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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.
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What Clinical Trial Decision Makers Are Prioritizing In 20255/7/2025
In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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Rescuing Data Integrity: A Swift Transition And Quality Transformation11/14/2025
Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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Powering Complex Personalized Medicine Oncology Trial2/25/2026
Managing custom therapies requires a synchronized supply chain. Learn how to bridge the gap between manufacturing and clinical workflows to ensure seamless patient care in complex oncology trials.
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Helping To Power The WHO Solidarity Trial Against COVID-193/21/2025
To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.
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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.
NEWSLETTER ARCHIVE
- 07.11.26 -- Clinical Leader Newsletter - Best Of June
- 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
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.
