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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-2154674637-AI-hand-software-ripple]( "Agentic AI And How It's Impacting Clinical Trial Research")
Agentic AI And How It's Impacting Clinical Trial ResearchSince ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
-
ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
-
Retention Begins With Recruiting The Right-Fit Patients11/13/2025
Recruiting the right patients into a clinical trial is only half the battle. To combat attrition, sponsors must also institute measures that ensure patients remain comfortable and confident throughout the trial.
-
If Data Integrity Matters, Paper Is Not An Option3/5/2026
Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.
-
Futureproofing Post-Approval Compliance4/15/2026
In the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.
-
Reducing Inventory Errors In Clinical Trials5/8/2026
Can a digital double-check save your trial from data errors? How does verifying shipments at receipt slash inventory mistakes? Learn to protect protocol integrity and patient safety.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
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.
-
Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
-
Guiding GLP-1 Participants Through The Challenge Of Retention12/4/2025
Learn how remote lifestyle coaching can combat high dropout rates in metabolic research by offering the support participants need to maintain adherence and ensure data integrity.
-
Setting A New Client Standard In Study Closeout Timelines4/4/2025
Learn how a top-10 global pharmaceutical company achieved a significantly faster time to market for a high-profile therapy.
-
Successful SwissMedic Marketing Authorization Application For An Oncology Therapy6/4/2026
See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.
-
Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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.
-
![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.
-
![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?
-
![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
-
![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.
-
![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.
-
![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.
