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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.

AI-Driven Clinical Trial Recruitment and Design

AI can improve recruitment only when it is embedded in protocol design, EHR-enabled matching, patient engagement, site workflow, and governance. The highest-value near-term use cases are human-in-the-loop decision-support applications with documented context of use, validation, privacy controls, and bias monitoring.

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.

2025 Veeva R&D and Quality Summit: Effectively Utilizing Clinical Reference Data

Explore the challenges sponsors and CROs face in maintaining clinical reference data, uncover the hidden costs of traditional upkeep models, and see how integrated data solutions can streamline operations across the clinical ecosystem.

Harnessing Data Analytics and AI for Clinical Trials

Balancing these tools with operational efficiencies can aid CROs in meeting the evolving needs of sponsors.

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

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

Accelerating Breakthroughs with Synthetic Clinical Trial Data

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

Crossing the Digital Chasm: Site Burden Isn’t an Excuse Anymore

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.

Beyond Regulatory Intelligence: How an FSP PV Partner Helps Ensure Global Compliance

Support from these partners can aid drug and medical device developers in keeping up with the evolving regulatory landscape.

Clinical Trials in 2026: Platformization, AI Fluency, and the Redrawing of the Value Chain

The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.

Saving the Last Mile of Medicine

Sample integrity and traceability often fail not because of science but because clinical trials rely on manual processes and fragmented systems that obscure problems until samples are already compromised.