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What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care

Yelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for 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

GUEST COLUMNISTS

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.
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.
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.
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.
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.
Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients
CEO Jay Lalezari and CFO Robert E. Hoffman share how CytoDyn meet patient needs when they approach trial design for cancer trials.
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.
Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site
Consultant Jason C. Bork identifies 10 of the most common points at which a trial can break down before and after patient recruitment.

CLINICAL TRIAL WHITE PAPERS

Transforming Effective Patient Recruitment Within The Changing Health Care Landscape
Revolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.

ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations
11/21/2025

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.
Routes To Sponsor Of Choice: Shared Pipelines, Streamlined Payments
10/30/2024

Paying clinical trial sites consistently on time provides stability and maintains positive relationships. Learn why being a sponsor of choice can mean the adoption of a singular clinical trial payments solution.
4 New Approvals In Q3 Across Gene, Cell, RNA Therapies
11/13/2025

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.
Radiation Therapy Quality Assurance In Clinical Trials
8/22/2024

Here, the authors describe the crucial role of radiation therapy in oncology trials and how a robust quality management program can enhance treatment outcomes and research efficacy.
How Sponsors Can Drive Success With Central eSource At Investigator Sites
6/17/2025

Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments
2/3/2025

A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study
3/12/2026

Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
Sleep Assessment In Sleep Disorders
3/16/2026

Discover how continuous, objective monitoring in a home environment captures sleep improvements that traditional lab-based snapshots often miss, ensuring more accurate clinical outcomes.
Unlocking Recruitment Potential In Trial-Naïve Sites
4/17/2025

Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
Rescuing Data Integrity: A Swift Transition And Quality Transformation
11/14/2025

Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
Optimizing EDC Strategy And Data Collection for a Rare Disease Trial
6/11/2025

Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

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.

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.
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.
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

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.
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.
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.