Clinical Leader - Helping clinical research professionals connect and collaborate

Working hard for success-GettyImages-2201479298

Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure Innovation

To secure long-term innovation, Ascendis Pharma's Ivanna Rosendal suggests pharma companies should help startup companies through their growing pains.

GUEST COLUMNISTS

Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' Process
Learn how a formal "lessons learned" process can help teams work collaboratively with open, honest, and timely communication to reach thoughtful decisions that lead to on-time, on-budget, and inspection-ready trials.
4 Factors Changing The Way CRAs Monitor Trials
The way CRAs monitor is about to change. Regeneron's Patrick Floody discusses these four factors that will influence it.
How Can AI Change Computerized System Validation?
Learn how AI technologies are changing the computer system validation (CSV) landscape and what you need to understand about this transformation.
Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites
Incomplete protocols, lengthy sponsor decision timelines, and uncompensated work plague clinical research sites. Learn why these issues exist and how to address them alongside experts from SCRS and Tufts CSDD.
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?
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.

CLINICAL TRIAL WHITE PAPERS

The Strategic Advantage Of eCOA And IRT
The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.

Bladder Cancer Global Clinical Trial Landscape (2024)
11/12/2024

Bladder cancer is the ninth most common cancer in the world and thirteenth in mortality. This report provides a detailed overview of the clinical trial landscape for bladder cancer.
A Strategic Guide For Biotech And Biopharma Leaders
5/15/2025

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.
In-Vivo CAR Therapies — Global Research And Development Landscape
7/15/2025

Delve into the evolving in-vivo CAR therapy landscape, examining key technological innovations, major industry players, recent clinical progress, and regulatory developments.
Writing An IND Module 3 For Cell And Gene Therapy Products
9/1/2025

This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.
Global Trial Disclosure Landscape Grows Increasingly Complex
4/15/2025

The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission
1/27/2026

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.
Enhancing ER Patient Recruitment
6/26/2024

Scout's custom information delivery mechanism for clear, accessible patient education facilitated trial enrollment in a high-pressure emergency room setting.
EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?
7/23/2024

The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
Medable Platform Delivers >90% eCOA Adherence And Scalability
7/8/2024

Discover how eCOA use drove >90% adherence across an extensive weight management master protocol clinical trial with multiple sub-studies across 70+ research sites.
Use Case: A Patient-Centric Approach To Site Selection
1/27/2025

Discover how Citeline’s robust datasets, combined with real-world data, inform intelligent site and investigator selection for a rare, autoimmune disease.
Guiding GLP-1 Participants Through The Challenge Of Retention
12/4/2025

Learn how remote lifestyle coaching can combat high dropout rates in metabolic research by offering the support participants need to maintain adherence and ensure data integrity.

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.

Building Patient Trust In Research Through Connection Driven-Transparency

The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
Patient Trust In Pharma Is Low; Here's How To Rebuild It

CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
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.

FOCUS ON PATIENTS

Building Patient Trust In Research Through Connection Driven-Transparency

The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
Patient Trust In Pharma Is Low; Here's How To Rebuild It

CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
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.