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Authors

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 mchristel@mjhlifesciences.com.

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

AI and Patient Recruitment: Can Predictive Promise Drive True Transformation?

Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.

Michael Christel

Michael Christel is Group Managing Editor of Applied Clinical Trials, Pharmaceutical Executive, and BioPharm International. He can be reached at mchristel@mjhlifesciences.com.

Latest Article

Next-Generation Focus in Immuno-Oncology

How one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.

Paul O'Donohoe

Senior Director, eCOA Product and Science, Medidata

Latest Article

Navigating the Intersection of Accessibility and Measurement Integrity in eCOA

Clinical research evolves to prioritize patient-centered outcomes, integrating accessibility standards in electronic data capture for inclusive clinical trials.

Kai Langel

Founder and CEO, DEEP (Digital Endpoints Ecosystem & Protocols) Measures

Latest Article

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.

Sean Connolly
Sean Connolly

Evinova AG

Latest Article

Moving Beyond Disappointing Pilots: Scaling Adoption of AI-Enablement in Drug Development

Most AI pilots in drug development fail not from poor technology but from lack of strategic prioritization, organizational readiness, integrated data infrastructure, and disciplined governance, making success dependent on business discipline rather than technical capability.

Tushar Sinkar
Tushar Sinkar

Tushar Sinkar is an AI and digital transformation leader with experience across clinical trials, enterprise technology, product delivery, and regulated transformation. He focuses on translating complex operational challenges into scalable digital capabilities across process orchestration, data readiness, governance, and responsible AI adoption.

Latest Article

The Control Plane for Agentic Clinical Operations: Governing Autonomous Digital Actors in Regulated Trials

AI agents in clinical operations acquire broader autonomous capability through expanded permissions, tools, memory, and delegated authority, requiring governance focused on whether effective capability has shifted outside approved boundaries rather than whether software has changed.

Estelle Haenel, PharmD, PhD

Chief Medical Officer at Kayentis

Latest Article

Answering the Sustainability Call: Digital Health Technologies and eCOA

Sustainability should be central to clinical trial design and considerate of how digital tools such as electronic clinical outcomes assessments can help achieve this.

Charlie Paterson

Health and Life Sciences Expert, PA Consulting

Latest Article

Evolving FDA Risk Tolerance Reshapes Global Trial Alignment

Charlie Paterson, partner at PA Consulting, explains how mixed signals on FDA risk tolerance are accelerating the globalization of clinical trial programs and reshaping how sponsors align development activities worldwide.

Olga Elizarova, DDS, MPH, MBA

Senior Consultant Behavioral Science, S3 Connected Health

Latest Article

Behavioral Science in Clinical Trials: Part 3 — Why Diversity Must Be Built Into Trial Design

In part 3 of this three-part series, behavioral science reveals that clinical trial diversity cannot be achieved through last-minute recruitment efforts, but requires designing protocols, sites, and enrollment strategies around the real barriers and needs of underrepresented communities from the outset.

SCOPE
Latest Article

Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit

In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.

Jennifer Ross

Director of Biostatistics, Almac Clinical Technologies

Latest Article

Master Protocols & IRT: 5 Questions Sponsors Must Ask Before Selecting a Randomisation Partner

Master Protocols-including platform, umbrella, and basket trials-offer significant benefits and efficiencies in drug development compared with traditional trial protocols. However, their perpetual nature, adaptive designs, and evolving requirements make randomisation inherently more complex. As a result, implementing and maintaining robust randomisation for Master Protocols can be challenging for sponsors. Selecting the right IRT provider is therefore critical. This paper outlines five essential questions sponsors should ask when evaluating IRT providers for Master Protocols, with a focus on long-term trial success, regulatory readiness, and operational resilience.

Jayanthi Anbil
Latest Article

The Evolution of Preclinical CRO Strategic Partnerships: From Transactional Services to Value-Driven Ecosystems in 2026

As the life sciences industry continues to evolve, the ability to effectively manage and leverage preclinical CRO partnerships is set to become a defining characteristic of successful biopharma companies.

Quotient Sciences
Latest Article

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.

JoAnne Bronikowski, BSCS, RAC

Senior Manager, Regulatory Affairs, ICON

Latest Article

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.

Nicholas Whitney

Senior Director, Site Suite, IQVIA

Latest Article

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.

Scottie Kern
Latest Article

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.

Martin Wing-King

Vice President and General Manager, Quotient Sciences

Latest Article

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.

Elisabeth Piault-Louis
Latest Article

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.

Paraxel
Mark Sawicki, PhD
Mark Sawicki, PhD

President & CEO, Cryoport Systems

Latest Article

Clinical Site Readiness for Cell and Gene Therapies: Operational and Supply Chain Challenges as they Scale and as they Expand into the Community Care Setting

Cell and gene therapy access expands into community care settings only when operational coordination, site readiness, and supply chain standardization become first-order priorities equivalent to manufacturing capacity, requiring standardized processes, digital integration, and distributed logistics networks.