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2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets

Vibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.

Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research
Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What

GUEST COLUMNISTS

The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management
Market expert Mathini Ilancheran explains how sponsors can mitigate the effects of "Most Favored Nation" drug pricing while maintaining trial integrity and accelerating time to market.
Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.
How Is RIM Software Transforming Regulatory Compliance?
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
Why CRA Proficiency Needs A Boost From Better Assessment And Training
CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.
EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025
Single Peptides & Pig Testing: How Longhorn's Developing Its Universal Flu Shot
CEO Jeff Fischer discusses Longhorn's long-acting universal flu vaccine, from its suitability for testing in pigs to overcoming vaccine hesitancy.
BioMarin Generates Patient Experience Data With Early And Often Engagement
BioMarin Pharmaceutical's Ebony Dashiell-Aje, Ph.D., discusses how early and often patient engagement facilitates rich patient experience data generation.

CLINICAL TRIAL WHITE PAPERS

Clinical Trial Disclosure Compliance: A Moving Target
To date this year, 115 updates to clinical trial disclosure rules have been tracked across global regulatory agencies. See what types of changes have occurred, where they were, and how they are implemented.

The Rescue Option: Course Correcting Struggling Clinical Trials
4/14/2025

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.
Driving Customer Profitability With Enterprise Platform, Pricing
2/29/2024

Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.
Planning For High-Performance Hematologic Oncology Clinical Trials
5/7/2024

Running successful clinical trials in hematologic malignancies necessitates a deep comprehension of a swiftly evolving treatment framework that is growing more nuanced, intricate, and patient-centered.
Considerations For Plain Language Summaries
4/22/2024

Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.
Site Perspectives On BYOD ePRO Use
6/17/2024

This study examines participant convenience and compliance, aiming to understand and address the challenges faced by site personnel in global trials.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Optimize Startup And Payment Processes
8/31/2023

Delve deep into the collaborative journey where global CRO Linical was able to revolutionize its financial lifecycle of clinical trials—from initial budgeting to seamless site payments.
EHR-To-EDC Success In A Complex, Adaptive Platform Trial
4/17/2025

I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.
RWD's Significance In The Largest FDA-Funded IOL Study Of Pediatric Patients
5/28/2025

With FDA grant support, the American Academy of Ophthalmology and Verana Health conducted the largest real-world study to date on intraocular lens (IOL) use in pediatric cataract patients.
Global Pharmaceutical Company Implements Remote Clinician Ratings
8/30/2023

Uncover the secret to how this pharma company was able to implement remote clinician ratings in a multinational Alzheimer’s disease.
CRO Uses CRIO eSource To Double Monitoring Productivity
1/31/2025

Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.
Essity Uses eConsent To Optimize Enrollment
8/15/2023

See how a global hygiene and health company was able to deploy virtual methods through a strategic partnership to recruit and retain participants, streamline consent, and analyze patient data.

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.

Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research

CEO Marc Deschamps shares how ischemic stroke treatment has overshadowed that of intracerebral hemorrhage, negatively impacting recruitment for ICH clinical trials. To turn the tide, he advocates for accurate diagnoses, more specialized care, and less restrictive enrollment criteria.
Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What

What do air traffic control, nuclear power plants, and aircraft carriers have in common? Patient recruitment expert Tatty Scott argues clinical researchers should look at these industries to inspire more precise trial execution.
BioMarin Generates Patient Experience Data With Early And Often Engagement

BioMarin Pharmaceutical's Ebony Dashiell-Aje, Ph.D., discusses how early and often patient engagement facilitates rich patient experience data generation.

FOCUS ON PATIENTS

2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets

Vibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.
Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials

Gilead’s Carrie Frenette discusses the company's art campaign centered on primary biliary cholangitis to bring awareness to the condition and create more patient-centric trials for patients.
Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy

Medicine is not one-size-fits-all. Here, strategic advisor Bill Hanlon implores pharma to develop therapeutics and diagnostics anchored by racial and ethnic diversity.