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.
- Could Study Rehearsals Create A New Standard For Site Readiness?
- The Much-Feared FDA Form 483, Part 2
- Opus Genetics Shows Proper Planning Is Key To Adaptive Trial Design
- Building A Future-Proof, GxP-Compliant IT Infrastructure
- The Much-Feared FDA Form 483
- Unlocking Biopharma Innovation With Real-World Evidence
- Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment Response
GUEST COLUMNISTS
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![Medical coding, billing-GettyImages-2183119831]( "Unlocking Biopharma Innovation With Real-World Evidence")
Unlocking Biopharma Innovation With Real-World EvidenceDiscover 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.
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![Duality-GettyImages-2174708053]( "Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment Response")
Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment ResponseLearn how Bayesian digital twins are trained, validated, and trusted in clinical settings and explore the potential for integrating these models into interventional trials.
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![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Bridging Language And Medicine: Best Practices In French Regulatory Medical WritingPoor 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.
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![(c) Kevin Scott - Paul Allen Research Center1689]( "Research Center Layout Helps Lower Barriers To Cross-Industry Collaboration")
Research Center Layout Helps Lower Barriers To Cross-Industry CollaborationDiscover 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.
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![Claude, gemini, chatGPT AI icons-GettyImages-2232624047]( "Elsa's AI Model Migration: Technical, Compliance, And Regulatory Risks For Sponsors (Part 2)")
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.
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![bechtel getz series article 4]( "Site Staffing On The Upswing, But Still A Challenge")
Site Staffing On The Upswing, But Still A ChallengeIn 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.
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![Data, business analysis-GettyImages-1652005966]( "From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs")
From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually NeedsLearn 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.
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![anticancer drug, ADC-GettyImages-2148345960]( "Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials")
Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC TrialsZymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1278800031 diverse trial participants]( "Completed Clinical Trials, Terminations Both Rose In 2023")
Completed Clinical Trials, Terminations Both Rose In 2023This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.
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Master Protocols: Implementing Effective Treatment Adaptations8/25/2025
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
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A Promising Rebound in Clinical Trials10/23/2024
This report explores how clinical trials bounced back in 2023 from their decline a year earlier despite continued geopolitical, regulatory, and pricing pressures.
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Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology4/11/2025
Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.
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The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting10/30/2024
The twin pressures of inflation and attrition prolong negotiations between sponsors and clinical sites, stalling drug development. Sponsors need up-to-date, reliable benchmark data to negotiate fair market value budgets.
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Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Global Vaccine Trials Case Study5/22/2024
Explore targeted strategies for tackling the complexities of international payments and providing comprehensive participant support in global vaccine trials.
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Launching A Unified Global Sales Team In 90 Days11/7/2025
A global CRO united 300+ sales and executive leaders across five continents for a dynamic, space-themed meeting that strengthened culture, deepened product understanding, and inspired alignment toward annual growth goals.
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Accelerating Clinical Data Review With Traceable Workflows12/3/2025
Clinical data review needs centralized access and traceable workflows. Leveraging AI-automation and real-time collaboration drives faster, better-informed decisions and reduced compliance risk.
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How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives6/5/2024
Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.
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Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy9/25/2025
Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.
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How eSource Reduced Benchmark's Protocol Deviations By Almost 40%1/6/2025
Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.
NEWSLETTER ARCHIVE
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.
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![translate foreign language with internet software-GettyImages-2215567295]( "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.
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![Gold key hung in the middle-GettyImages-1310224740]( "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.
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![Doctor and patient in nursing home-GettyImages-1345138968]( "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
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![translate foreign language with internet software-GettyImages-2215567295]( "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.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "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.
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![Doctor and patient in nursing home-GettyImages-1345138968]( "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.
