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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.

To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures
From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams

Inside ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive T-Cell Malignancies
Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients
Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies
Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site
The U.S. Clinical Trial Recruiting Pipeline Report – June 2026
Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency

GUEST COLUMNISTS

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.
The U.S. Clinical Trial Recruiting Pipeline Report – June 2026
This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from May 1 to June 30, 2026.
Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency
PA Consulting's Naveed Panjwani explores how to improve pipeline productivity via resource utilization, tech-enabled operations, and execution discipline.
Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume
TransCelerate BioPharma members Ashlin Dunne, Anne Marie Inglis, and Ann Katrine Miranda assess the state of site training, examine how training affects trial execution, and discuss a better path forward.
The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To Know
Beroe Inc. analyst T.G. Prasanna discusses agentic AI for clinical research and how it must be evaluated as a regulated operating cost transformation, with platform, orchestration, compliance, validation, and oversight costs modeled together.
Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
CuraCell Head of Clinical Operations Torbjörn Ström discusses, in the context of CC-38 and CytoPLY-derived tumor-infiltrating lymphocytes (TILs), the utility of named-patient experience, dosing and preconditioning, and T-cell therapy capabilities in cold solid tumors.
What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence
Pistoia Alliance President Becky Upton, Ph.D., reviews findings from a poll about AI use in clinical research conducted at Clinical Trials Technology Congress (CTTC) that revealed barriers to adoption, early ROI, emerging use cases, and the role of patient-generated data.
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.

CLINICAL TRIAL WHITE PAPERS

Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems
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.

Go From Three Meetings To One With AI-Enabled eCOA
5/5/2026

Learn how to turn three meetings into one with AI that is streamlining clinical workflows by reducing redundant steps, simplifying site operations, and accelerating data collection.
Enhancing Clinical Trial Flexibility
9/1/2025

Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.
Patient-Focused Data Capture For Cancer Research
8/21/2025

In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
The Next Era Of eCOA Is AI
4/15/2026

Discover how AI is moving beyond the hype to streamline clinical study builds. Explore practical ways to automate protocol digitization and UAT scripts while preparing for future patient tools.
Faster Starts, Stronger Finish: Operational Excellence In NSCLC
5/22/2026

In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Study Analysis – Site Payment Automation
12/8/2025

By removing administrative bottlenecks, see how automation improves cash flow for sites, reduces operational burden for sponsors, and supports smoother, more predictable trial execution.
Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning
1/31/2025

The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments
1/15/2025

Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
Drive Superior Enrollment, Speed, And Quality Using eSource
1/3/2025

Explore a detailed analysis of 140 research sites involved in a Phase III trial, highlighting significant advancements in trial performance and data quality using CRIO’s eSource platform.
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.
Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer
11/17/2025

Choose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.

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.

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.
5 Informed Consent Fixes For Sponsors And Investigators

Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.

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.