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
-
![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.
-
![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.
-
![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.
-
![(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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-2153183419-digital-signature-eConsent]( "Global e-Consent Matrix")
Global e-Consent MatrixNavigate complex regional regulations and identity requirements to modernize your global clinical trial enrollment. Ensure compliance and access while moving toward digital participant engagement.
-
Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
-
Disclosure Management System: Build Or Buy?6/19/2025
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
-
Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
-
A Strategic Guide For Biotech And Biopharma Leaders5/15/2025
Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.
-
How AI Is Reshaping Trial Design, Execution, And Disclosure9/25/2025
AI has quietly embedded itself into the operational heart of clinical development, where it is accelerating decisions, reducing manual burden, and improving outcomes.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
-
Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission1/27/2026
Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
-
Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.
-
Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
-
Leading Recruitment With A Strong Alzheimer's Referral Pool2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
-
FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study3/12/2026
Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
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.
-
![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.
-
![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.
-
![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
-
![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.
-
![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.
-
![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.
