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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

AI in Pharma: Benefits, Risks, And The Road Ahead
How could leveraging AI technologies, including machine learning (ML) and generative AI (GenAI), enable your company to streamline processes from drug discovery to post-launch?

RWD, New Technologies Show Potential In Clinical Trial Recruitment
7/10/2025

Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
Safeguarding Personal Data: Protecting PII
8/4/2025

Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.
Futureproofing Post-Approval Compliance
4/15/2026

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.
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.
Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems
10/6/2025

Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution
8/18/2025

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.
How eSource Reduced Benchmark's Protocol Deviations By Almost 40%
1/6/2025

Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.
Breaking Down Operational And Financial Complexity In Clinical Trials
12/8/2025

Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.
Optimizing Wearable Adherence In A Phase 3 Oncology Trial
5/15/2026

Long-term wearable monitoring only works if patients keep wearing the device, and in oncology trials, that’s easier said than done.
Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study
1/6/2025

Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.
Transforming Clinical Trial Sites With Research Study Rockstar
2/10/2025

This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.

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.