Clinical Leader - Helping clinical research professionals connect and collaborate

privacy, data breach, cybersecurity-GettyImages-2214686070

When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down

Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.

How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026
The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development

GUEST COLUMNISTS

Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial
Discover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.
The Uncomfortable Conversation: AI And Data Use In Clinical Trials
AI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.
When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
The Cost Of Transactional Thinking In Clinical Research
Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.
Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)
Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
Safe And Sustainable DCTs and Hybrid Trials (Part 2)
In part two of this series, learn practical cloud architectural patterns, governance structures, and operating mechanisms that allow sponsors to run hybrid and decentralized trials.
Why Sponsors Should Share KPI Rationale With Sites
To build partnerships, foster transparency, and promote shared accountability, Curo Research CEO Amy Bland explains why sponsors need to communicate the utility of KPIs with sites.
Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial
Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).

CLINICAL TRIAL WHITE PAPERS

Conducting Early Phase Clinical Trials In Diverse Healthy Populations
Download our guide to learn proven strategies for designing early phase clinical trials that successfully enroll diverse populations and meet FDA diversity guidance.

Managing Placebo Response To Improve Clinical Trial Success Rates
2/20/2026

Many effective therapies fail in Phase 3 trials because high placebo response rates mask their true benefits. Successfully navigating this challenge requires a proactive, multi-pronged approach.
Deriving Reliable Clinical Outcome Scores From Continuous DHT Data
6/10/2025

DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.
Study Start-Up Challenges: Hard Realities, Effective Strategies
3/13/2024

Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?
Participant Payments: Navigating Modern Studies
12/18/2024

To address the challenges of disbursing clinical trial participant payments globally, sponsors need region-specific payment solutions that navigate local laws and banking systems.
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.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study
4/15/2025

Discover how a clinical development program was saved using objective, continuous digital outcome measures.
Leading Recruitment With A Strong Alzheimer's Referral Pool And Clean Data
2/24/2026

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.
CRO Takes Trial Build Times From Weeks To Days
5/27/2025

Recognizing the inefficiencies in traditional build processes, a top global CRO partnered with Medable to transform its approach to clinical trial launch.
Changing The Clinical Feasibility Game With AI
1/22/2026

AI is only as good as the data it’s built upon. Our customized AI platforms are constructed on a foundation of trustworthy, carefully curated data to produce detailed, expert-driven responses.
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.
Launching A Unified Global Sales Team In 90 Days
11/7/2025

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.

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.

When A Clinical Trial Surfaces In An AI Chat, What Happens Next?

AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.

FOCUS ON PATIENTS

Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease

The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.