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After the Trial is too Late: The Case for More Active Use of Patient-Reported Outcomes in Oncology Studies

Advancing toward more meaningful use of PRO data by making it systematic, transparent, and built into trial design.

Clinical Trial Monitoring: Should Randomization Be Included?

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

Foundational Content Consolidation for Regulatory-Ready Digital End Points: Insights From Public-Private Partnerships

Public-private collaboration and structured evidence consolidation are emerging as critical enablers of regulatory-ready digital end points, helping standardize terminology, reduce duplication, and accelerate the integration of digital health technologies into clinical research and decision-making.

The Challenges of Buying Blind: Why Providing the Clinical Outcome Assessment Measure Prior to License Execution Would Significantly Benefit Clinical Trial Set-Up

Persistent delays and inefficiencies in COA licensing and translation stem from limited pre-license access and fragmented processes, making a strong case for providing outcome assessment measures earlier to reduce risk and accelerate trial start-up.

A Signal Isn’t Resolved Until It Stays Closed—RBQM Lessons

Analysis of more than 880 clinical trials shows that while statistical data monitoring and key risk indicator signals close on similar timelines, durability—not speed—is the defining differentiator in effective, risk-based quality management.

Tapping the Patient Voice as a Strategic Differentiator

The future of clinical trial design involves incorporating the patient experience into strategic asset planning.

Harnessing Unstructured Data and Hospital Interoperability

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

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

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.

What Real-World Data Shows About Current Cancer Care

Webinar Date/Time: Thu, May 7, 2026 1:00 PM EDT

Front-Loading Drug Development: Q&A with Jenna DiRito, PhD, Revalia Bio

In this Q&A, Jenna DiRito, PhD, COO and co-founder of Revalia Bio, discusses how earlier, human-relevant data is reshaping go/no-go decision-making in drug development and what a truly front-loaded workflow looks like in practice.

Clinical Trials as a Competitive Edge: Strategic Considerations

Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.

The Future is Now: Four Ways AI and Other Tech Advances are Enhancing Clinical Trials

Emerging applications of AI/ML, automation, and digitization are helping sponsors cut clinical trial start-up times to as little as four weeks, reduce data errors, and enhance patient engagement—demonstrating how tech-enabled processes are reshaping trial efficiency and experience across the study lifecycle.

When AI Learns to Speak Every Language: An eCOA Migration Study

New data show that applying AI to the migration of translated COAs into eCOA platforms can meaningfully reduce errors, accelerate localization workflows, and support broader global patient participation—while still relying on human reviewers to ensure linguistic precision and clinical integrity.

Evolving Toward Empowerment: How We Are Deepening Relationships With Patients

Multilayered strategies such as working with patient advocacy organizations and leveraging technology can help industry better partner with patients.

Harnessing Technology and Adopting Unified Approaches to Optimize Pharmacovigilance Activities

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

Why Real-World Evidence Can No Longer Wait Until After Approval

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

Critical Questions to Ask Your IRB

Find out if you’re working with the right IRB.

Focusing on Site Needs and Challenges: Quick Tips for Sponsors/CROs

Gain insight into how listening to site feedback and prioritizing engagement, training, and local patient understanding can drive smoother startups and stronger study outcomes.

Rethinking Oncology Trials With a Statistical Methodology That Puts Patients First

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, and patient-centered outcomes in oncology trials.

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

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

Notable Discussions from SCOPE 2025: Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug Development

This year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA.

Embracing Proactive Multi-Indication Development for Metabolic Therapies

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial design, targeted patient selection, and real-world evidence to speed label expansion.

What Does Racial Color-Blindness Mean for Clinical Trial Participation?

Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.

What Patients Want From Remote Trials: New Survey Data Reveals Preferences Around Usability, Trust, and Participation

New survey data show a strong patient preference for fully remote clinical trials, underscoring how convenience, intuitive technology, and FDA-cleared digital tools are reshaping enrollment and retention strategies as decentralized models become a lasting fixture in clinical research.

The Future is Now: Four Ways AI and Other Tech Advances are Enhancing Clinical Trials

Emerging applications of AI/ML, automation, and digitization are helping sponsors cut clinical trial start-up times to as little as four weeks, reduce data errors, and enhance patient engagement—demonstrating how tech-enabled processes are reshaping trial efficiency and experience across the study lifecycle.

How Bayesian Approaches Can Revolutionize Rare Disease Clinical Trials

As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more flexible, data-driven approaches that integrate prior knowledge, reduce sample size demands, and align with evolving FDA guidance to accelerate evidence generation.

Noteworthy Focus Points That Help Differentiate Anti-Obesity Drug Development Strategies in a Rapidly Evolving and Expanding R&D Landscape

As highly effective anti-obesity therapies emerge and regulatory expectations evolve, sponsors are adopting innovative trial designs, addressing long-term weight maintenance, monitoring lean mass preservation, and preparing for expanded safety and demographic requirements that will define the next era of obesity R&D.

Establishing the Right Foundation for Patient Safety in 2025

How biopharmas are advancing their pharmacovigilance operations.