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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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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Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic
As 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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Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence
Clinical 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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To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures
UNC 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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From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams
AbbVie'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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4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs
Gaps 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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ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies
ImvivaBio 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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Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
With 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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5 Questions To Ask Before Selecting A Randomization Partner
Choose the right IRT partner for complex master protocols. Learn how adaptive randomisation expertise and flexible technology reduce disruption and keep trials execution-ready.
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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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Completed Clinical Trials Continued To Climb In 20246/19/2025
Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
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Rapid Expansion Of Peptide And Nanobody Drug Conjugates7/21/2026
Peptide and nanobody drug conjugates are gaining momentum, with 106 active programs identified globally. Learn more about the fast-evolving space for targeted drug delivery and competitive opportunities.
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Bringing Clinical Trials To Everyone's Backyard1/10/2025
Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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Modernizing Clinical Trial Logistics To Deliver Value2/3/2026
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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Retention And Access In NSCLC Clinical Trials5/12/2026
Helping participants navigate respiratory limitations, fatigue, and complex visit schedules in Non-Small Cell Lung Cancer (NSCLC) studies.
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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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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Drilling Down On Diversity And Feasibility12/8/2025
A mid-sized contract research organization (CRO) sought help with writing clinical trial diversity action plans and assessing feasibility for therapeutic areas outside its usual scope.
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Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
NEWSLETTER ARCHIVE
- 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
- 08.07.26 -- Unify Glucose Monitoring And Enable Passive Abnormal Movement Monitoring
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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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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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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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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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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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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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.