Lupus Nexus unites a registry, biorepository, and data exchange to give researchers longitudinal real-world data without building the infrastructure from scratch.
- Walmart's Clinical Trial Model Faces Its Real Test
- A Window Into Aging: Why Skin Is the First Test For RLS-1496
- Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCs
- Brazil's Regulatory Transformation: Expanding Clinical Trial Participation
- Washington's Clinical Trial Alphabet Soup
- Brazil's Regulatory Transformation: A New Era For Clinical Development
- The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI
GUEST COLUMNISTS
-
![AI vs human-GettyImages-2285304527]( "The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI")
The Real Problem In Patient Recruitment… Is Knowing How And When To Use AIAI 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.
-
![FDA-GettyImages-2271237562]( "An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?")
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?
-
![hurdles-GettyImages-2163832531]( "Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWE")
Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWEWearable 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.
-
![Doctor using tablet in hospital-GettyImages-2227564671]( "What Happens When Clinical Trial Patients Need Care Outside Of The Study?")
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.
-
![Team Blocks-GettyImages-1860565143]( "When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs")
When To Build Out Your ClinOps Team — And Other Advice For First-Time BiotechsSmall biotechs shouldn't model their ClinOps headcount after Big Pharma. Instead, they need the right capabilities, oversight, and risk controls. Consultant Jessica Cordes explains.
-
![OssiumHealth11]( "Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source")
Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor SourceOssium CEO Kevin Caldwell explains how an unconventional multisite Phase 1 trial is shaping the company's novel bone marrow product’s path ahead.
-
![privacy, data breach, cybersecurity-GettyImages-2214686070]( "Who Owns Your Clinical Trial Software When The Vendor Leaves?")
Who Owns Your Clinical Trial Software When The Vendor Leaves?When a clinical trial software vendor exits, sponsors still own the risk. Learn what to secure before signing a contract to protect data, validation, and continuity.
-
![FDA Headquarters MD-GettyImages-2278014569]( "What The New PDUFA Guidance Means For Drug Development")
What The New PDUFA Guidance Means For Drug DevelopmentLearn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.
CLINICAL TRIAL WHITE PAPERS
-
![scientist in a modern laboratory studies human body with HUD, graphic display-GettyImages-1396802026]( "Clinical Trial Evaluation And Referral Challenging For Physicians")
Clinical Trial Evaluation And Referral Challenging For PhysiciansPhysicians often encounter information gaps when evaluating clinical trials for patients. A recent survey indicates a fragmented, confusing trial information landscape that is difficult to navigate.
-
Five Ways Centralized Trial Finance Improves Site And Patient Satisfaction6/15/2026
Centralizing payments and logistics improves transparency, accelerates reimbursements, and supports better site performance and patient retention in clinical trials.
-
Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
-
A Guide to Digital Endpoints in Respiratory Diseases4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
-
Demanding More From AI Governance In Drug Safety8/13/2025
Embedding AI governance into your safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
-
Patient-Focused Data Capture For Cancer Research8/21/2025
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
A Mission To Expand Recruitment Territory6/11/2026
Learn how a proactive feasibility approach helps sponsors strengthen enrollment forecasting, mitigate risk, and implement timely interventions that improve study execution and clinical development.
-
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.
-
Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence3/10/2025
A top-10 global pharma company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites in Japan. Explore an initiative to enhance the patient and site experience.
-
Ergomed's Solutions To The Challenges of Oncology Trials4/15/2025
Explore a pivotal Phase III global clinical trial investigating neoadjuvant immunotherapy for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
-
How Expert Medical Information Support Strengthened A Rare Respiratory Therapy Launch5/26/2026
Embedded medical information expertise enabled compliant, real‑time scientific engagement with healthcare professionals at a high‑profile congress during a critical product launch.
-
Accelerating Enrollment And Upholding Quality In Complex Oncology Trials5/5/2026
Real-world oncology trials reveal how fast physician engagement, hands-on biomarker management, and adaptive enrollment shorten timelines, reach first-patient milestones, and preserve data quality.
NEWSLETTER ARCHIVE
- 11.06.26 -- Freeing Trial Data Without Losing Trust: AI, Precision Medicine, And Oncology Speed
- 11.06.26 -- Protect First-Patient Dates, Tighten Supply Oversight, And Stay Inspection-Ready
- 11.05.26 -- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
- 11.04.26 -- Feasibility Isn't Just A Technology Problem
- 11.04.26 -- The "Fantasy" On Both Sides Of Feasibility
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.
-
![Woman looking at the trees-GettyImages-1449632739]( "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.
-
![US map healthcare icons-GettyImages-522620544]( "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.
-
![AI vs human-GettyImages-2285304527]( "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
-
![US map healthcare icons-GettyImages-522620544]( "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.
-
![Doctor using tablet in hospital-GettyImages-2227564671]( "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.
-
![Patient ultrasound examination-GettyImages-1473904792]( "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
