Authors

Breaking the Efficacy Ceiling in IBD and Beyond

AbbVie’s head of immunology clinical development, Kori Wallace, MD, PhD, discusses how combination therapies, translational science, and emerging immune-reset approaches could usher in a new era of treatment for inflammatory bowel disease and other autoimmune conditions.

Next-Generation Focus in Immuno-Oncology

How one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.

Navigating the Intersection of Accessibility and Measurement Integrity in eCOA

Clinical research evolves to prioritize patient-centered outcomes, integrating accessibility standards in electronic data capture for inclusive clinical trials.

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.

Answering the Sustainability Call: Digital Health Technologies and eCOA

Sustainability should be central to clinical trial design and considerate of how digital tools such as electronic clinical outcomes assessments can help achieve this.

Evolving FDA Risk Tolerance Reshapes Global Trial Alignment

Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.

Behavioral Science in Clinical Trials: Part 3 — Why Diversity Must Be Built Into Trial Design

In part 3 of this three-part series, behavioral science reveals that clinical trial diversity cannot be achieved through last-minute recruitment efforts, but requires designing protocols, sites, and enrollment strategies around the real barriers and needs of underrepresented communities from the outset.

Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit

In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.

Master Protocols & IRT: 5 Questions Sponsors Must Ask Before Selecting a Randomisation Partner

Master Protocols-including platform, umbrella, and basket trials-offer significant benefits and efficiencies in drug development compared with traditional trial protocols. However, their perpetual nature, adaptive designs, and evolving requirements make randomisation inherently more complex. As a result, implementing and maintaining robust randomisation for Master Protocols can be challenging for sponsors. Selecting the right IRT provider is therefore critical. This paper outlines five essential questions sponsors should ask when evaluating IRT providers for Master Protocols, with a focus on long-term trial success, regulatory readiness, and operational resilience.

Evolving Leadership Competencies for Clinical Trial Project Managers

Rising development costs, low success rates, and increasing trial complexity are reshaping the clinical trial project manager role, demanding stronger digital fluency, adaptive leadership, and expanded stakeholder coordination to deliver studies efficiently.

De-Risking FIH: Integrated Strategies for Rapid Proof-of-Concept

The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging development milestones, beset by unknown risks, unexpected data, and potential regulatory hurdles to overcome. In this article, Quotient Sciences experts discuss how proper planning can avoid missteps in first-in-human studies, looking at trial design, CMC, and regulatory considerations.

Clinical Strategies to Optimize Software as a Medical Device to Treat Mental Health

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.

Beyond the Buzzwords: What SCOPE 2026 Revealed About Clinical Trial Planning and Operations

Insights from SCOPE 2026 highlight the industry’s shift toward connected, data-centric clinical trial ecosystems, where digital protocols, shared data, and renewed scientific rigor are driving more efficient, interoperable, and patient-focused research.

When Does Paper Make Sense for Clinical Outcome Assessment Data Collection?

Despite clear data quality and regulatory advantages, paper-based clinical outcome assessments persist due to cost asymmetry, trial complexity, startup timelines, and provider capability gaps, though hidden paper costs and loss of institutional knowledge often outweigh upfront electronic implementation expenses.

Optimizing Clinical Trial Efficiency: The Power of Simplicity for First-in-Human Studies

How industry can increase the speed of these trials while continuing to meet patient needs.

Investigative Site Investment, Preparedness, and Experience with Digital Solutions

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong support for remote data collection—while highlighting persistent burdens tied to fragmented systems, training demands, and financial strain.

Revenue Recognition Risk in Contract Research Organizations

Managing financial integrity in a complex, milestone-driven operating model.

Controlled Clinical Trials in Sub-Saharan Africa: A Winning Value Proposition

Persistent recruitment delays, high dropout rates, and missed timelines continue to slow global clinical trials, while data show that sub-Saharan Africa offers a largely untapped opportunity with established research capacity, large patient pools, and strong enrollment and retention performance.

Accelerating Breakthroughs with Synthetic Clinical Trial Data

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

Future Proofing Your Outsourcing Strategy: How to Stay Agile in a Fast-Moving Clinical Trial Ecosystem

A blend of FSO and FSP models in the landscape of artificial intelligence can ensure CROs stay up to date with the unique demands of industry.

Utilizing Tech Tools to Accelerate Drug Development

In a decentralized, digitally enabled clinical trial environment, conventional approaches to data analysis are evolving as sponsors utilize technological tools in new ways to ensure compliance with global standards, mitigate risk, and bring life-changing therapies to patients faster.

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

Balancing Scientific Innovation with Lived Experience: A Strategic Imperative in Pediatric Clinical Trials

Pediatric trial participation shapes children's and caregivers' long-term psychological outcomes, yet protocol design often overlooks experience as a variable affecting recruitment, retention, and data integrity—a gap increasingly recognized by regulators and quality standards

Reprioritizing DNA Damage Response: Leveraging Lessons Learned to Develop Next-Generation Inhibitors

Advancements in this field have the potential to transform cancer care and improve quality of life for patients.

Validity, Reliability, and Regulatory Considerations for Consumer Devices in Clinical Research Data Collection

Consumer-grade wearables offer promise for reducing trial burden and improving engagement, but accuracy and reliability vary substantially by device, measurement, and population, requiring rigorous fit-for-purpose validation and careful endpoint selection before integration into regulated research.

AI-Enabled Systems Medicine: From Digital Promise to Clinical Operating Model

AI-enabled systems medicine could influence which populations are selected for trials, how biomarkers are validated, how products are positioned, how evidence is generated after launch, and how value is demonstrated to payers.

Detecting Fraud in Clinical Trials Using Statistical Data Monitoring

Exploring stat-based testing for variables that identify deliberate data manipulation in clinical trials.

Language of Medicine: Translating Between German and English

The complexities behind these translations require specialized personnel who are nuanced in both medical cultures.

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.