Opus Genetics shares how FDA alignment yielded a clearer path for its ultra-rare LCA5 gene therapy, shaping trial design, evidence generation, and operations.
- Rebecca Jackson: EHR-To-EDC Needs A Reality Check
- What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury
- 3 Ways To Solve Data Friction In Modern Clinical Data Management
- How Visible Is Your Clinical Trial To AI?
- The Rare Trials Summit Wants To Produce More Than Conversation
GUEST COLUMNISTS
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![AI powered search Engine-GettyImages-2215176753]( "How Visible Is Your Clinical Trial To AI?")
How Visible Is Your Clinical Trial To AI?Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
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![bottleneck, searchscope-GettyImages-2166479887]( "Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic")
Threat From Within: Why Biopharma's Drug Development Bottleneck Is SystemicAs FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions.
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![GettyImages-1826452239_data]( "Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence")
Beyond Task Tracking: Why ClinOps Needs Dependency IntelligenceClinical trial operations will always need task tracking, but they're not enough on their own. Dependency intelligence shifts the focus toward readiness not reaction.
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![Backpain-GettyImages-512749727]( "To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures")
To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome MeasuresUNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.
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![medications in shopping basket-GettyImages-2281371864]( "From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams")
From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development TeamsAbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.
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![GettyImages-2208609448_business]( "4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs")
4 Hidden Gaps In Clinical Trial Preparation For Small BiotechsGaps are not always visible at the executive level, but their consequences are very real — affecting timelines, budgets, data quality, and ultimately the likelihood of regulatory success.
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![pharmacist checks inventory, drug shelves-GettyImages-1941443650]( "ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies")
ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive MalignanciesImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
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![Money, finance, economic value-GettyImages-2271167891]( "Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy")
Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor StrategyWith the help of Beroe Inc.'s Surya Ponnam, discover how per-patient cost (PPC) analytics is evolving into a core capability for balancing cost, quality, speed, and patient outcomes.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-2185301590-microscope-scientist-lab]( "Matching Pharmacovigilance Methodology To Organizational Scale")
Matching Pharmacovigilance Methodology To Organizational ScaleOne-size-fits-all doesn't work for safety signal detection. Discover a scalable framework that keeps expert judgment at the center — no matter how large your portfolio grows.
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Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
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What Re-Acquisition In Retinal Imaging Is Really Costing Your Program4/6/2026
High screen failure rates and patient dropout often stem from preventable imaging errors. Learn how proactive quality control and patient-centric logistics secure critical retinal trial data.
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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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Pharma R&D Annual Review Supplement: New Active Substances4/15/2026
Last year was by some distance the best year ever in terms of new active substances. Explore the 105 new debuts that easily outstrips that of the previous record holder, 2021’s, 97.
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Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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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Accelerating A Schizophrenia Trial While Ensuring Quality7/31/2026
Tight timelines and rising patient targets don't have to derail a trial. See how speed and data quality can work together from enrollment to database lock.
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Building A Scalable Oncology Engine In A Dynamic Market6/3/2026
Learn how a top-10 global pharmaceutical company partnered with Medable to rapidly scale the number of oncology trials it could concurrently conduct.
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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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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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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?
NEWSLETTER ARCHIVE
- 08.12.26 -- Smarter Trials Don't Happen By Accident
- 08.12.26 -- eTechnologies Improving Trial Design And Execution
- 08.11.26 -- Rethink What Works In Clinical Trials: From Protocol Design To Digital Workflows
- 08.10.26 -- What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
- 08.08.26 -- Clinical Leader Newsletter - Best Of July
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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![AI powered search Engine-GettyImages-2215176753]( "How Visible Is Your Clinical Trial To AI?")
Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
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![Inefficiency, delays, confusion, public administration-GettyImages-2213159033]( "Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies")
Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
FOCUS ON PATIENTS
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
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![MRI_forPR_final-(4)-(1)]( "Digital Twins Enhance Disease Progression Measurements In FSHD")
Digital twins can transform trial design by making data more robust and alleviating patient burden. In this interview, Epicrispr CEO Amber Salzman, Ph.D., shares how the company's using it to reliably predict muscle volume change in their trial for a FSHD gene therapy.
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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.
