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With A Clear Focus And Promising Asset, Crystalys Is Skipping Phase 2 Trials For Gout

Crystallis President and CEO James Mackay shares insights from the company’s clinical decision-making for dotinurad, including the inclusion of an open label extension.

GUEST COLUMNISTS

Unlocking Biopharma Innovation With Real-World Evidence
Discover how how federated data networks, platform aggregators, and collaborative partnerships have evolved to meet the data demands of modern product development, regulatory strategy, and commercial success.
Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment Response
Learn how Bayesian digital twins are trained, validated, and trusted in clinical settings and explore the potential for integrating these models into interventional trials.
Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
Research Center Layout Helps Lower Barriers To Cross-Industry Collaboration
Discover how one research center, uniquely built for collaboration, enables the collection and analysis of high-quality specimens and data that will fuel both current and future research collaborations.
Elsa's AI Model Migration: Technical, Compliance, And Regulatory Risks For Sponsors (Part 2)
In the second part of their series on Elsa AI model migration, Kimberly Chew, Esq., and Michael Yang, Esq., analyze the risks to compliance and data residency, as well as the integrity of the regulatory record.
Site Staffing On The Upswing, But Still A Challenge
In this final article of the series, Jimmy Bechtel and Ken Getz discuss how workforce pressures have shaped site performance and what’s being done to strengthen site staff retention and career growth.
From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs
Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.
Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
Zymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.

CLINICAL TRIAL WHITE PAPERS

The Patient Experience Paradox: eCOA Strategy Overhaul
European regulatory shifts now require the systematic integration of patient data. Success depends on aligning clinical and market access strategies through rigorous evidence generation.

What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?
1/28/2025

Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.
Digital Endpoint Resource Guide: Sleep Disorders
12/10/2025

Sensor-driven digital endpoints track sleep patterns and disruptions, standardize trial outcomes, and enable remote monitoring that reduces patient burden while improving treatment-response insights.
Global Trial Disclosure Landscape Grows Increasingly Complex
4/15/2025

The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
Patient Diversity: Identifying Challenges, Opportunities, And Best Practices
4/10/2024

By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
A New Blueprint For Transforming Feasibility And Recruitment
9/22/2025

Discover how a connected approach links feasibility and recruitment, using real-world data to design realistic protocols, reach the right patients, and accelerate enrollment with confidence.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

3-Week Database Builds That Withstood FDA Review
3/31/2026

Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.
Early-Stage Development In Rare Pediatric Oncology
4/11/2025

Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
Supporting Participants Through National Travel Disruptions
12/10/2025

A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.
How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives
6/5/2024

Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.
Optimizing Recruitment For Urgently Needed Vaccine
5/15/2024

Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.
End-To-End Inventory Control Supports Biotech's Expanding Portfolio
2/19/2026

Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.

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.

Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing

Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
The Art Of Finding And Keeping The Right KOL

Learn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients

Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.

FOCUS ON PATIENTS

Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing

Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman

Origami Therapeutics CEO Beth Hoffman shares how the company took both a measured and a gut-feeling approach to finding the right partner to supports its development of protein degraders for neurodegenerative diseases.
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients

Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.