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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

Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay
From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.

Overcome Patient-Level Access Barriers For New Medicine
3/23/2026

Explore market access from the patient’s perspective and identify five aspects of how people get hold of medicine that should inform commercialization.
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.
Automated Evidence Generation For Regulatory-Grade RWD
10/20/2025

Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.
A Practical Guide To Harnessing The Value Of APAC For Global Trial Success
8/21/2026

As Phase III costs and complexity rise, APAC offers faster enrollment, lower costs, and market access advantages, but capturing that value requires early planning and in-region expertise.
Eliminate Clinical Trial White Space With The Right AI Strategy
10/9/2025

Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.

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CLINICAL TRIAL APP NOTES & CASE STUDIES

Integrate Trial Payments With One Service Provider For Efficiency
11/6/2026

Reduce trial complexity by integrating travel, payments, reimbursements, and financial oversight to remove patient barriers and give sponsors and sites clearer spending visibility.
Successful SwissMedic Marketing Authorization Application For An Oncology Therapy
6/4/2026

See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.
Biometric Services For Large Pharmaceutical Company
7/31/2025

This case exemplifies the effectiveness of flexible staffing solutions in meeting the dynamic needs of the biopharmaceutical industry while maintaining control over project deliverables and timelines.
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.
Setting A New Client Standard In Study Closeout Timelines
4/4/2025

Learn how a top-10 global pharmaceutical company achieved a significantly faster time to market for a high-profile therapy.
Delivering An Early-Phase Autoimmune Trial Across Regions
11/6/2026

Why do autoimmune trials stall when patients already have working treatments? See how one rare rheumatology study adapted its strategy to keep early-phase enrollment moving.

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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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