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.

Merck Reports Strong Phase II Results for Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer

The IDeate-Lung01 trial showed a 48% confirmed response rate with Merck’s B7-H3 directed antibody-drug conjugate in previously treated extensive-stage small cell lung cancer, with durable benefit observed across second- and later-line patients, including those with brain metastases.

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.

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

Accelerating Breakthroughs with Synthetic Clinical Trial Data

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

The Mandate Myth: What Actually Moves the Needle on Inclusive Research

Advancing more inclusive and representative clinical trials through action and accountability.

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.

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.

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.

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

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

Clinical Trial Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New Investors

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

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.

Leveraging Technology for Efficient Trial Design

Teams must work together with technology solutions and optimize integration to unlock their full potential.

The Importance of Using Cognition as an Endpoint in Clinical Trials

How cognitive evaluations can aid in meeting the growing demand for more comprehensive safety profiles.

Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025

At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.