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Once the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.

Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AI
Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' Process

GUEST COLUMNISTS

What CROs Do Right Isn't Always Obvious To Research Sites
CROs are doing many things right. But it's when that right thing is understood — not just executed — that the impact becomes far greater than compliance alone.
How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials
VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.
3 Clinical Research Attorneys Talk 2026 Trends
Three life sciences legal experts share what they see happening in the year ahead — and what should remain firmly in the past.
The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk
When it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.
Common Issues And Trends In Clinical Research Vendor Qualification
Discover the biggest challenges in vendor qualification, including this one misalignment that affected more than half of surveyed respondents.
"Study Within A Study" Reveals Best Recruitment Strategies For Alzheimer's Trials
In this Q&A, Acumen Pharmaceuticals shares findings from its Alzheimer's recruitment study, highlighting what efforts proved the most fruitful.
Endpoints, Procedures, And Deviations Are On The Rise — Why?
SCRS Chief Site Success Officer Jimmy Bechtel, MBA, and Tufts CSDD Executive Director Ken Getz, MBA, discuss why they're on the rise explore ways to address, and even accept, them.
Navigating FDA's New AI Systems: Practical Tips For Regulatory Success
AI-assisted reviews are changing FDA submissions. In part two of this series, discover how sponsors can address and even preempt regulatory and legal concerns.

CLINICAL TRIAL WHITE PAPERS

Deal-Making Volume Slowed In 2023
This report provides an overview of alliance, merger and acquisition, and financing deal activities across the global biopharma, medical device, and in vitro diagnostics industries in 2023, as reported by Biomedtracker.

Guide To Pharmaceutical CAPA And Quality Management
3/14/2025

CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.
Paper Vs ePRO: Clinical Data Collection Methods
7/16/2024

Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.
Completed Clinical Trials, Terminations Both Rose In 2023
6/13/2024

This 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.
De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital
9/3/2025

For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
Advancing Alzheimer's Disease Therapies
9/3/2025

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.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Advancing Oncology Innovation With Adaptive Trial Designs
8/12/2025

When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.
Using eConsent Data To Populate Site And Sponsor Data Systems
10/7/2024

A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.
Redefining Accessibility For Pediatric Patients
9/24/2025

Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
GxP Inventory Solution Delivers Real-Time Visibility, Operational Efficiency
12/10/2025

Explore how unified forecasting and GxP-level inventory control can streamline your clinical supply chain, reduce risk, and strengthen oversight across every trial you run.
Enhancing Investigator Training And Communication During COVID-19
6/26/2024

Centralizing all trial-related information, enabling seamless interaction and global team coordination through Scout Academy.
RTSM: Randomization And Cohort Management, IP Inventory Management
4/17/2024

Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.

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.

The U.S. Trial Advantage Is Eroding

Once the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.
Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients?

New AI health assistants are now doing even more to help patients make sense of symptoms, diagnoses, and treatment options. What does that mean for the discoverability of clinical trials?
How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials

VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.

FOCUS ON PATIENTS

How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials

VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.
Confronting "Time Toxicity" In Global Oncology And Rare Disease Trials For Operational Excellence And Patient Retention

Time is the only truly finite resource in a clinical trial. Consultant Leila Cupersmith discusses how sponsors can better design trials with a lower time burden to boost enrollment, retention, and overall operational excellence.
Working (Well) With Patient Advocates: The Sponsor POV

Aeovian CEO Allison Hulme reflects on Aeovian Pharmaceuticals' partnership with the TSC Alliance and how it’s informed research and development of their first-in-class selective mTORC1 inhibitor.