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Authors

Mary Gunn, PhD, MBA

CEO of Emerald Clinical Trials

Latest Article

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.

Jessica Taylor Jones

Head of Digital Patient Engagement – PRE, Patient and Site Centric Solutions, IQVIA

Latest Article

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.

Jonathan Norman

Director of Localization & Scale Management, YPrime

Latest Article

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.

Susan Campbell

Global Head of Patient Recruitment, ICON

Latest Article

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.

Daniel O’Keeffe

VP, Product, Qinecsa Solutions

Latest Article

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.

Christopher P. Boone, PhD

Group Vice President of Research Services, Oracle Health and Life Sciences

Latest Article

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.

BRANY
Latest Article

Critical Questions to Ask Your IRB

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

Caroline Potts

General Manager, Site & Patient Services, Medical Research Network (MRN)

Latest Article

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.

Rudradev Sengupta

Senior Trial Design Lead at One2Treat

Latest Article

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.

Sarah Burge

With Cambridge University Hospitals NHS Foundation Trust

Latest Article

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

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

Katie Shaw

Senior Director, Patient Recruitment and Enable, Global Patient and Site Services, IQVIA

Latest Article

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.

Alan Baldridge, MD

Senior Director, Gastroenterology and Hepatology, Drug Development Solutions, ICON

Latest Article

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.

Jennifer Kim, Keith Maddox, Madison Ford, and Marissa Hill
Latest Article

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.

Jiang Li

CEO of Vivalink

Latest Article

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.

Gavin Hershaw

Director, Customer Experience, IQVIA Laboratories

Latest Article

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.

Billy Amzal

Head of Strategic Consulting at Phastar

Latest Article

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.

Laura Higginbotham, MD, MPH

Vice President Therapeutic & Regulatory Strategy, IQVIA

Latest Article

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.

Mike Kruczek

Senior Director, Veeva Vault Safety strategy

Latest Article

Establishing the Right Foundation for Patient Safety in 2025

How biopharmas are advancing their pharmacovigilance operations.

William Garton

Senior Director, Site Contracts and Payments, PPD clinical research business of Thermo Fisher Scientific

Latest Article

Elevating Clinical Research Site Relationships With New Budget and Payment Paradigms

How a deeper review of site budget and payment processes and technology is driving meaningful change in the industry.

Shawn Blackburn

President, YPrime Labs

Latest Article

Enhancing eCOA Through AI: A Look Ahead to 2025

The three areas poised for a transformation in the advent of electronic clinical outcome assessment technologies.

Chase Carmeans

SVP of Operations at YPrime

Latest Article

3 Common eCOA Implementation Challenges and How to Solve Them

Overcoming hurdles with licensing complexities, post-production changes, and IRB submissions can help in reducing timelines and increasing collaboration.

Harpreet Smith, MBA, MSN, RN
Harpreet Smith, MBA, MSN, RN
Latest Article

How to recruit specialty volunteer populations for early-phase clinical research: 5 things to ask when choosing a CRO partner

In early development, effective volunteer recruitment is critical for building a robust package of clinic trial data, ensuring scientific validity, containing study costs, and maintaining timelines. In studies that require specific types of volunteer populations, it’s important to develop a focused plan for recruitment.

Otis Johnson, PhD, MPA

Founder & Principal Consultant, Vantix Operations

Latest Article

Beyond Compliance: NetraMark's Joseph Geraci, PhD, on Making AI-Driven Patient Subgroups Explainable

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Geraci, PhD, co-founder and chief scientific and technical officer at NetraMark, about why explainable AI, not black-box prediction, is needed to reveal clinically meaningful patient subgroups in regulated drug development.

Manny Vazquez

Senior Director, Clinical Data Strategy, Veeva

Latest Article

Four Strategic Considerations to Choose an EDC

Companies share their experience in future-proofing clinical data technology.

Carie Pierce

SVP, global head of growth & business development, DIA

Paulo Rodrigues

Co-Founder and Chief Product Officer, QMENTA

Latest Article

Beyond the Hype: An Evidence-Based ROI Analysis of Cloud-Native vs. Traditional Imaging Infrastructure in Clinical Trials

As imaging-heavy clinical trials grow more complex and globally distributed, sponsors are increasingly re-evaluating traditional infrastructure models, with cloud-native platforms showing potential to reduce operational burden, accelerate site activation, improve imaging quality oversight, and lower total trial costs.

Noah Nasser

CEO, datma

Latest Article

Addressing Population Gaps in Therapy Adoption: Using Real-World Data to Bridge the Clinical Trial Divide

How clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.

Sabrina Steffen

Vice President, Head of Innovation & Data Strategy, Data Sciences, Safety & Medical, IQVIA

Latest Article

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.

Graham Bell

Director, Global Regulatory Strategy, ICON plc

Latest Article

Preparing to Achieve with Joint Clinical Assessments

Strategies for sponsors in navigating the European Union's new health technology assessment regulation.

Mike Munsell, PhD

Director, RWD HEOR at Panalgo, a Norstella company

Latest Article

In an Uncertain Policy Environment, Pharma Needs Timely Real-World Data More Than Ever

In an era of constant policy change, timely real-world data is emerging as pharma’s most critical tool to track patient access, anticipate shifts in treatment utilization, and improve outcomes in real time.