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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.

Otis Johnson, PhD, MPA

Founder & Principal Consultant, Vantix Operations

Latest Article

Beyond Compliance: ProofPilot's Joseph Kim and Lauren Briggs on Making Clinical Trial Training Actually Work

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Kim, Chief Strategy Officer at ProofPilot, and Lauren Briggs, Chief Customer Officer at ProofPilot, about why completing training is not the same as being prepared to execute a protocol.

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.

Arvind Ramanujam, MS; Carrie Northcott, PhD; Jacqueline Thong, MBA; and Jared Worful, MS, MBA
Latest Article

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.

Anna Dudalyan

Implementation Project Manager, Clinical Operations Department, Kayentis

Latest Article

Modernizing Patient-Reported Outcomes: Bridging the Gap Between Legacy Measures and Contemporary Healthcare

Strategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.

Castor
Latest Article

AI in Biotech Clinical Development: Why You Can't Afford to Retrofit

As emerging biopharmas race to integrate Artificial Intelligence into their clinical pipelines, many make the costly mistake of retrofitting AI onto slow, legacy EDC systems. Watch this expert panel to learn how modern, AI-native clinical data platforms automate data reconciliation, accelerate study builds, and future-proof your Phase II/III trials.

Lightship
Latest Article

Accelerate Inclusive Enrollment and Delivery with Lightship

David MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials.

Christoph Pfeiffer

Founder of Competitio

Latest Article

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.

Sarah Kosta, PhD

Clinical Trial Solutions Analyst, One2Treat

Latest Article

Enhancing Empowerment in Patient-Focused Research

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.

Verily
Latest Article

Transforming Healthcare Data

We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data — and there are more data modalities — to draw from for biomedical research than ever before. However, the quantity, variance and speed of data generation outpaces researchers’ ability to effectively utilize it to reveal medical breakthroughs for those in need. The ability to analyze health data is critical in developing a precision health approach. By leveraging diverse data sources, researchers can determine the most effective actions for individuals and communities. However, current barriers to data access and collaboration hinder progress. To accelerate the pace of discovery, a solution is needed to close the gap between research and health care. This paper describes how Verily Workbench provides solutions for healthcare professionals and researchers to easily access and collaborate on data within an integrated analysis and governance framework. Workbench provides a community of researchers with the platform, data, and tools to solve the most pressing scientific challenge

Stuart Cotter

Vice President of Technology Strategy, Advarra

Latest Article

The Latest Advancements in Single Sign-On Technology

How today’s SSO reduces site burden and spearheads clinical system interoperability.

Hugo Stephenson, MD

Co-Founder and Executive Chair, TrialScreen

Latest Article

Older Adults Are More Digitally Engaged in Trials Than We Think

Older adults generate disproportionately high engagement in digital trial recruitment, suggesting they represent an overlooked opportunity when recruitment systems are designed around their actual behavior rather than outdated assumptions about digital capability.

Hilde Vanaken, PhD, Eng, MsC

Head, Pharma R&D Transformation, TCS Life Sciences, and Head, European Forum for Good Clinical Practices (EFGCP) eConsent initiative

Latest Article

Making Communications Resonate: Wherever People Are, In Their Own Words

The traditional global-to-local communication model creates fragmented content through sequential adaptation, but a local-first approach using structured data and AI-orchestrated generation can embed stakeholder terminology and preferences from the start, reducing rework while improving clarity and relevance.

Michael Christel

Michael Christel is Group Managing Editor of Applied Clinical Trials, Pharmaceutical Executive, and BioPharm International. He can be reached at [email protected].

For more past ACT content by Christel not included below, click here. And you can find Christel’s latest feature writing, analysis, and podcasting for Pharm Exec here.

Latest Article

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.