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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

Accelerating Chronic Disease Clinical Study Reports With AI-Enabled Medical Writing And Expert Oversight
AI-enabled medical writing can cut clinical study report timelines by up to 70%, helping teams manage growing chronic disease trial documentation without sacrificing quality or oversight.

AI In Precision Medicine: Predictive Insight To Operational Confidence
9/21/2026

AI-enabled precision medicine trials depend on strong data governance and security, enabling predictive operational intelligence while preserving human oversight and appropriate conventional analytics.
How Sponsors Are Responding To FDA's RTCT Request For Information
9/9/2026

Let's take a look at where continuous, real-time regulatory review can meaningfully speed drug development, and where it likely won't help much.
A Smartphone Based Biomarker For The Estimation Of Unipolar Depression Severity
3/28/2025

The study investigates the potential of using smartphones and wearables to create objective biomarkers for mood disorders, specifically focusing on unipolar depression.
Understanding Immunogenicity In AAV Gene Therapy
8/14/2025

As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
Potential Of eClinical Solutions To The Complexity Of Oncology Trials
7/31/2025

How are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Scaling Success: A Blueprint For Flexible Biometrics Partnerships
2/19/2026

Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
Turning Rapid Study Start-Up Into Enrollment Momentum
9/18/2026

A large Phase III ATTR-CM outcomes trial spanning 37 countries reached 50% enrollment eight months early, with monthly accrual rates running 3–5x above plan through coordinated cross-functional execution.
Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration
5/27/2026

Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
Accelerating CRO Study Deployment At Scale
7/7/2025

A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.
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.
Recruitment To Screening: Bridging The Gap
12/5/2025

Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.

More Clinical Trial App Notes & Case Studies

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.

More Editorial Collections