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Two Parallel Trials, A Potential New Option For Protection From COVID-19

Invivyd’s Michael Mina, MD, Ph.D., discusses LIBERTY and DECLARATION, exploring how monoclonal antibodies could expand COVID-19 protection alongside vaccines.

Firsthand Findings: How Incannex Is Designing Trials That Support Regulatory Approval
The 2026 Pharma R&D AI Sourcing Map: Partnerships, Concentration, Inflection

GUEST COLUMNISTS

Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCs
Our expert chat about Brazil’s clinical research transformation concludes with SBOC President-elect Fabio Franke, who explores building sustainable trial capacity beyond the country’s major AMCs.
Brazil's Regulatory Transformation: Expanding Clinical Trial Participation
A discussion of Brazil’s clinical research transformation continues as this Q&A series turns to Maiko L. Tonini, Ph.D., of Brazil’s Ministry of Health, to explore expanding clinical trial participation.
Brazil's Regulatory Transformation: A New Era For Clinical Development
Brazil’s clinical research transformation takes center stage as this new Q&A series opens with Interfarma CEO and former ANVISA director Renato Porto.
The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI
AI might find patients faster, but only people earn their trust. A site COO explains how to pair AI speed with human judgment, plus the guardrails every site should build in.
An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWE
Wearable data is easy to collect but difficult to turn into trusted RWE. Explore six fixes for the most common data problems when using wearables in research.
What Happens When Clinical Trial Patients Need Care Outside Of The Study?
Clinical trial patients may need care outside of the trial protocol. Discover how closing information gaps can protect safety, trial participation, and data integrity.
When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
Small biotechs shouldn't model their ClinOps headcount after Big Pharma. Instead, they need the right capabilities, oversight, and risk controls. Consultant Jessica Cordes explains.

CLINICAL TRIAL WHITE PAPERS

Completed Clinical Trials Continued To Climb In 2024
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.

Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials
11/21/2025

This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies.
The eCOA Iceberg
5/27/2026

Understand the true cost of eCOA deployment, beyond software licenses, to reduce protocol risk, avoid operational bottlenecks, and protect study timelines and data quality.
A Guide to Digital Endpoints in Respiratory Diseases
4/15/2025

Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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.
Five Integration Pillars To Redefine Frontline Patient Engagement And Safety Operations
8/20/2026

Siloed medical information, patient support, product quality, and pharmacovigilance functions, alongside increasing biopharmaceutical complexity, require a unified operating model to meet modern demand.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Delivering Complex Oncology Trials At Scale
5/19/2026

Parexel delivered two complex, global Phase III prostate cancer trials by aligning site selection, logistics, imaging workflows, and RAM regulatory expertise—achieving faster enrollment and on‑time execution.
How a Biopharmaceutical Company Improved Site Satisfaction
8/12/2026

Eliminate site payment delays and reduce clinical trial admin burden. Learn how one sponsor cut payment timelines from 120+ days to under 30 days while boosting site satisfaction.
Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder
5/27/2026

Global approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.
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.
ICON And Medable Drive 85% eConsent Adoption In U.S. Menopause Study
4/1/2026

A site-focused strategy drove strong eConsent adoption in a complex women’s health study, showing how tailored training and hands-on support boost engagement and compliance.
Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays
9/25/2025

Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

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NEWSLETTER ARCHIVE

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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.

Lupus Researchers Now Have A Three-Pillar RWD Platform To Support Discovery And Development

Lupus Nexus unites a registry, biorepository, and data exchange to give researchers longitudinal real-world data without building the infrastructure from scratch.
As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access

Milken Institute's Kristin Schneeman explains how a new action plan could broaden patient access in the U.S. — and what sponsors and policymakers can do now.
The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI

AI might find patients faster, but only people earn their trust. A site COO explains how to pair AI speed with human judgment, plus the guardrails every site should build in.

FOCUS ON PATIENTS

As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access

Milken Institute's Kristin Schneeman explains how a new action plan could broaden patient access in the U.S. — and what sponsors and policymakers can do now.
What Happens When Clinical Trial Patients Need Care Outside Of The Study?

Clinical trial patients may need care outside of the trial protocol. Discover how closing information gaps can protect safety, trial participation, and data integrity.
Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care

Can early APG-157 treatment control head and neck cancer without delaying curative care? A Phase 3 trial puts timing, safety, and outcomes to the test.

EDITORIAL COLLECTIONS

Take a deep dive into the issues shaping clinical research today with our curated Editorial Collections. Each collection features expert insights and practical strategies addressing today’s biggest challenges in clinical trial planning and execution.

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