Authors

Precision Oncology Trials Need to Reflect the Complexity of Cancer Biology

Phase III oncology setbacks often reflect incomplete biological understanding rather than target failures, but robust biomarker strategy and multi-dimensional patient selection developed early in development can strengthen pivotal trial design and increase success.

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

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

Applying Systems Thinking to the Future of Clinical R&D

Clinical R&D modernization stalls through incremental optimization of individual workflows, but meaningful systemic change requires leaders to visualize structural relationships, understand hidden incentives, and identify leverage points that benefit the whole system rather than parts.

Provider Participation in a National VA Pragmatic Trial: The Diuretic Comparison Project

Findings from the VA’s Diuretic Comparison Project show pragmatic trial designs can achieve strong provider participation when burden is minimized and patient care remains the primary focus.

A Guide to Patient Engagement & Recruitment (PER) Solutions

A sponsor faced recruitment roadblocks for a Phase II oncology clinical trial. The solution: Citeline PatientMatch, leveraging RWD and natural language processing for optimal site and patient selection.

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.

Rethinking Clinical Trial Data in the Era of Decentralization

Before Burden Becomes Risk: Capturing Friction in Real Time

Experience sampling captures real-time signals of site burden and operational friction at the moment they occur, providing earlier and more actionable insight than retrospective assessments and revealing workarounds before they compound into protocol deviations.

Data Quality Across the Clinical Trial Lifecycle: What It Takes to Fully Trust Your Data

From point-of-care sample collection to real-world data curation, wearable device integration, and continuous review infrastructure, data quality is not a single problem in clinical trials—it is a layered challenge that manifests differently at every stage of development and demands a different set of solutions at each one.

A Digital Twin of RAS Wildtype Metastatic Colorectal Cancer to Evaluate the Efficacy of Standard-of-Care

Digital twin technology can reliably simulate standard-of-care treatment outcomes using historical clinical trial data, offering a practical pathway to virtual control arms that reduce recruitment burden and address ethical concerns around placebo designs.

The CRA of the Future: From Monitoring Activity to Strategic Site Partnership

Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic site partners, but organizations need analytics training, clear operating models, and active change management to make the shift stick.

Characterizing the Protocol-Guided Source Preparation Process at Investigative Sites

A collaborative study by the Tufts Center for the Study of Drug Development and CRIO identifies protocol interpretation and source document preparation as an understudied yet significant bottleneck in study start-up timelines that may hold key opportunities for efficiency gains.

Clarifying Ownership of IRT Data in Clinical Trials: Distinguishing Investigator-Controlled Data from Sponsor Operational Data

Unclear boundaries between investigator-controlled and sponsor-managed data in IRT systems are creating avoidable compliance risk, particularly around investigational product inventory and quality actions.

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.

Why Gender Equality Adds Up for Advancements in Statistics

Closing the gender gap in data science and tech requires tackling barriers at every stage, from early education through career advancement, while actively challenging the unconscious biases that continue to hold women back.

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.

2026-2027 Top 10 HEOR Trends

Complexity mastered: A blueprint for delivering simultaneous trials at scale

In this case study, discover how Parexel takes on the most operationally complex prostate cancer trials — delivering with confidence, speed, and control to de-risk pivotal programs, accelerate momentum, and help critical innovations reach patients faster.

Designing Incentives for CRO Selection: A Game-Theoretic Approach to Pharma Partnerships

Moving beyond vendor evaluation to incentive design in Phase II/III rare and genetic disease trials.

Accelerating Breakthroughs with Synthetic Clinical Trial Data

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

Building Trust, Not Just Enrollment: Q&A with Adrelia Allen, Merck

In this Q&A, Adrelia Allen, executive director of clinical trial patient diversity at Merck, discusses how the company is embedding diversity into clinical trial execution—from protocol design and site selection to long-term community engagement that extends well beyond individual trial timelines.

Building Confidence in Clinical Trial Data and Technology Processes

Why rigorous testing and validation matter more than ever.

Bringing Clinical Trials Into the Digital Era with eConsent

As decentralized and hybrid trial models expand, eConsent is emerging as a critical tool for improving participant understanding, reducing site burden, and strengthening data integrity through digital automation, accessibility, and regulatory compliance.

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.