Authors

New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity

Realtime Electronic Data Capture at Investigator Sites: Laboratory Data and Beyond

A Guide to Patient Engagement & Recruitment Solutions

Clinical trials have become increasingly complex over the past decades, making participant recruitment more challenging than ever. This guide explores common recruitment obstacles and offers strategies to overcome them using a patient engagement and recruitment solution.

Enhancing Empowerment in Patient-Focused Research

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.

Q&A: Strategies for Successful Global Clinical Trial Delivery

In this Q&A, Randa Wahid of Indero, and Lyn Mursalo, a freelance clinical research professional, share how sponsors and CROs can build collaborative partnerships, navigate global trial complexities, and apply practical strategies to deliver studies on time and with quality.

Imfinzi Plus FLOT Significantly Improves Overall Survival in Gastric and Gastroesophageal Cancer

New results from the Phase III MATTERHORN trial show AstraZeneca’s Imfinzi combination reduced the risk of death by 22% versus chemotherapy alone, marking a major advance for patients with resectable gastric and gastroesophageal junction cancers.

Digital Measures of Health: What’s in it for Patients?

Exploring the different stages in the development of a digital measure, and the activities and steps key to achieving meaningful impact for patients.

Setting the Limits of Autonomy with Autonomous Agents for Clinical Research

As pharma wrestles with whether to trust fully autonomous AI, semi-autonomous agents are emerging as a safer middle ground that reduces manual work, eliminates white space in clinical development, and accelerates trial timelines without compromising patient safety.

It’s Time for the Life Sciences Industry to Accelerate Action for Gender Equality

Addressing systemic barriers and biases faced by women in research to foster a more diverse talent pool.

Leveraging remote-based regional hubs in FSP partnerships

Cybersecurity in Service Provider Selection and Qualification: A Critical Aspect of Modern Clinical Research

As clinical research becomes increasingly digital, integrating rigorous cybersecurity assessments into CRO selection and qualification is essential to safeguard sensitive data and ensure trial integrity.

Accelerating Breakthroughs with Synthetic Clinical Trial Data

The emergence of AI-powered simulants in improving study efficiency.

Are Clinical Trial Diversity Initiatives at Risk of Being Dismantled?

Although DEI remains a core tenet in pharma, strategies and goals have been reframed to align with the evolving political climate.

Case for the Underdog: Unleashing the Potential for Small, Community-Based Research Sites

Sponsors and CROs that work with these sites can better reach marginalized communities.

Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting

As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.

Advancing Patient Engagement in Community-Based Oncology Research

Improving access while maintaining a high level of research.

A Shifting CDMO Landscape: The Rise of High-Science, High-Touch

This model, built around a mix of flexible, empathetic, and results-driven principles, may be uniquely positioned to navigate the changing dynamics and demands for contract development and manufacturing organizations.

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

The challenges, opportunities, and strategic outlook for oncology research centers.

The Compounding Power of Training: Early Investment Yields Exponential Returns

Why investing in truly effective training from the outset can pay off exponentially for clinical teams—and serve as a strategic advantage.

FDA’s Elsa AI Tool Raises Accuracy and Oversight Concerns

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

Leveraging AI/Machine Learning as an End-to-End Differentiator

A well-designed approach can benefit clinical trials from protocol design to site support.

Retention by Design: Operationalizing Patient-Centric Trials Without Increasing Site Burden

The quest to turn patient retention from a chronic challenge into a competitive strength—and one that benefits all stakeholders.

Clinical Trials are Getting More Diverse Thanks to AI—and Humans

Strategies for sponsors to utilize technology in reaching diverse patient populations.

The Backbone of Innovation: High Quality Datasets

Understanding the benefits and concerns associated with implementing datasets into clinical trial workflows.

Less is More in Clinical Data: The Road to Simpler and Better Trials

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

FDA Announces Ramifications of Government Shutdown Due to 2026 Lapse in Funding

FDA outlines its limited operations during the funding lapse, focusing on essential public health activities while halting new drug applications.

Harnessing Unstructured Data and Hospital Interoperability

The potential of next-generation platforms in transforming patient recruitment.

Clinical Trial Failure: A Data-Driven Perspective on Risk Mitigation

An increase in protocol complexity is paving the way for machine learning models to optimize trial design.

Overcoming Recruitment and Retention Barriers in Alzheimer’s and Dementia Studies

Webinar Date/Time: Thu, Oct 30, 2025 11:00 AM EDT

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT