In this three-part series, Paradigm Clinical Research CEO Kurt Mussina discusses the meaningfulness of a site's operating model to clinical trial sponsors. In part one, he first defines operating model types.
- How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients
- i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned
- Why "Steady Evolution" Best Describes AI's Future
- Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?
- How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa
- Unicycive Therapeutics' Framework For Speedier Clinical Trials
- Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder
GUEST COLUMNISTS
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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.
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![EMR, Electronic medical record-GettyImages-917611012]( "RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short")
RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall ShortChiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.
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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 Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join ThemAI 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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![International conflict, trade war-GettyImages-2238013885]( "Will AI And Agile Project Management Help Advance RBM?")
Will AI And Agile Project Management Help Advance RBM?Will AI-based tools embedded into risk based-monitoring prompt an Agile project management moment for clinical research? Sidharth Ananthanarayan explains why AI-based tools are not the answer but part of it.
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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 Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized FutureThe American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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![reef knot-GettyImages-2162094857]( "Why Building Long-Term Value And Making Clinical Progress Are Inextricable")
Why Building Long-Term Value And Making Clinical Progress Are InextricableDicot Pharma CEO Elin Trampe discusses how clinical milestones, financing strategy, shareholder value, and partnering considerations must be tightly integrated in early development through late-stage planning.
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![Healthcare, public health, emergency care-GettyImages-2256438497]( "What Sponsors Don't See: The Systems Behind Clinical Trial Delivery")
What Sponsors Don't See: The Systems Behind Clinical Trial DeliveryWhat do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1219551222-Patient-Person-Recruitment-Select]( "Merits Of A Multifaceted Approach To Clinical Trial Recruitment")
Merits Of A Multifaceted Approach To Clinical Trial RecruitmentThe best way to address clinical trial recruitment challenges is with a multifaceted approach that goes beyond traditional channels and ways of thinking.
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Unlock The Power Of Clinical Data Science3/9/2026
Discover a unified, AI‑driven approach that helps clinical teams manage growing data complexity, accelerate insight generation, and improve trial oversight to enable faster decisions.
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The Rapid Digitization Of Trials11/7/2024
It’s no secret that more trials are going digital. Hear from a panel of industry experts including Sanofi, Bayer, and the Clinical Trials Transformation Initiative (CTTI) as they discuss the evolution of digital trials and share their experiences.
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Decentralized And Community-Based Solutions Driving Women's Healthcare9/24/2025
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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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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The Patient Experience Paradox: eCOA Strategy Overhaul3/25/2026
European regulatory shifts now require the systematic integration of patient data. Success depends on aligning clinical and market access strategies through rigorous evidence generation.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Medable Platform Delivers >90% eCOA Adherence And Scalability7/8/2024
Discover how eCOA use drove >90% adherence across an extensive weight management master protocol clinical trial with multiple sub-studies across 70+ research sites.
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Community Engagement vs. Digital Engagement For Higher Enrollment8/28/2024
Explore the importance of tailoring recruitment strategies to specific populations and leveraging diverse channels to reach potential participants.
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Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
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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.
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Maintain Compliance Through Divestiture Without Disrupting Operations6/25/2026
Facing a divestiture? Learn how to protect historical quality records and stay audit-ready throughout the transition.
NEWSLETTER ARCHIVE
- 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
- 07.07.26 -- The Relationship Between AI And Clinical Trial Enrollment
- 07.06.26 -- The Patient Recruitment Debate Nobody's Having
- 07.03.26 -- Optimize Your Trial Data Journey
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.
