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Authors

Katie Celentino, DNP, RN, CMSRN

Vice President of Regional Operations, The START Center for Cancer Research

Latest Article

Advancing Patient Engagement in Community-Based Oncology Research

Improving access while maintaining a high level of research.

Elizabeth Hickman

Chief Business Officer at AustinPx

Latest Article

A Shifting CDMO Landscape: The Rise of High-Science, High-Touch

This model, built around a mix of flexible, empathetic, and results-driven principles, may be uniquely positioned to navigate the changing dynamics and demands for contract development and manufacturing organizations.

Felix Nensa

With University Hospital of Essen

Latest Article

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

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

Kelly Ritch

Chief Operating Officer, ArcheMedX, Inc.

Latest Article

The Earliest Warning Sign: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data

Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging indicators that arrive too late to prevent these problems instead of measuring readiness during training, when intervention still matters.

Chris Mazzolini
Latest Article

FDA’s Elsa AI Tool Raises Accuracy and Oversight Concerns

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

Currien MacDonald

Medical Chair Director at WCG

Latest Article

Engineered Bispecific Antibodies: Regulatory, Ethical, and Best Practice Guidelines

Ethical and regulatory considerations for safeguarding participants in bispecific antibody clinical trials, and best practices designed to optimize their success.

Rajneesh Patil

Vice President, Digital Innovation, IQVIA

Latest Article

A Look Back: AI and Pragmatic Trials Took Center Stage at SCOPE Summit 2025

Revisit top insights from SCOPE Summit 2025, where industry leaders explored how artificial intelligence is reshaping trial risk management and how pragmatic study designs are bridging the gap between clinical research and real-world care.

Kees Van Ooik

Vice President of eClinical Solutions at Almac Clinical Technologies

Latest Article

Orchestrating, Not Just Digitizing: How Sponsors Reduce Cost, Improve Quality, and Enable Open Innovation

The next phase of digital transformation in clinical research will not be defined by the number of platforms deployed, but by how well those platforms work together in service of participants, sites, and science.

Cara Brant

CEO of Clinical Trial Media

Latest Article

Clinical Trials are Getting More Diverse Thanks to AI—and Humans

Strategies for sponsors to utilize technology in reaching diverse patient populations.

Paul Mancinelli, PhD

Chief Technology Officer of WCG

Latest Article

The Backbone of Innovation: High Quality Datasets

Understanding the benefits and concerns associated with implementing datasets into clinical trial workflows.

Guilherme Andretta, PharmD, MBA

Director, Therapeutic Strategy Clinical Scientist, 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.

Drew Garty

Chief Technology Officer, Veeva Clinical Data

Latest Article

A Look Back: AI and Pragmatic Trials Took Center Stage at SCOPE Summit 2025

Revisit top insights from SCOPE Summit 2025, where industry leaders explored how artificial intelligence is reshaping trial risk management and how pragmatic study designs are bridging the gap between clinical research and real-world care.

Nicholas Jacbous
Latest Article

FDA Announces Ramifications of Government Shutdown Due to 2026 Lapse in Funding

FDA outlines its limited operations during the funding lapse, focusing on essential public health activities while halting new drug applications.

Rohit Mistry

CEO, IOMED

Latest Article

Harnessing Unstructured Data and Hospital Interoperability

The potential of next-generation platforms in transforming patient recruitment.

Rhiannon Hyde

Director, Governance and Transformation, uMotif

Latest Article

Partners for Success: Governance Best Practices to Streamline eCOA Trial Launch

Strong relational governance between technology vendors and sponsor–CRO teams is becoming a critical foundation for eCOA trial success, enabling faster study launches, clearer communication, proactive issue management, and sustained quality across entire trial portfolios.

Aleksa Jovanovic MD, PhD

Scientific Engagement and Innovation Specialist, Wemedoo AG

Latest Article

Clinical Trial Failure: A Data-Driven Perspective on Risk Mitigation

An increase in protocol complexity is paving the way for machine learning models to optimize trial design.

CenExel
Latest Article

Advancing Clinical Research in GLP-1 Therapies: Insights From a Principal Investigator

Webinar Date/Time: Thu, Jan 22, 2026 11:00 AM EST

Altair
Latest Article

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

Sharad Adekar, MD, PhD, CIP

Senior Medical Chair at WCG’s IRB in Puyallup, Washington

Latest Article

Engineered Bispecific Antibodies: Regulatory, Ethical, and Best Practice Guidelines

Ethical and regulatory considerations for safeguarding participants in bispecific antibody clinical trials, and best practices designed to optimize their success.

Scott Foster

Managing Director at NFP

Latest Article

Clinical Trial Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New Investors

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

Martha Azer, PharmD

Associate Director, Regulatory Policy North America, Johnson & Johnson

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.

Justine Koor

Justine Koor, Director, Quality Assurance at IQVIA

Latest Article

Preparation Tips to Minimize Impact of Regulatory Inspections for IRT Systems

Regulatory inspections of interactive response technology systems have surged 140% since 2022, signaling intensified global scrutiny of data integrity, randomization, and system validation in clinical trials.

Cara Woodruff

Director of Product Management, IRT, 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.

Kara Bastarache, CAE; Ruma Bhagat, MD, MPH; Beth Bieze, MA, CCRA, ACRP-PM, FACRP; Kimberly Demirhan, MBA, BSN, RN; Mona Gilliam, MSN, APRN-BC, CNS; Susan P. Landis, BA; Katie Marceau, RN, MS-NL, OCN, CCRP; Nicole Richie, PhD; Latha Shivakumar, PhD; and Marian Valia
Latest Article

Upskilling Community Cancer Centers: A Training Pilot Hints at Promising Ways to Boost Oncology Clinical Research

This pilot project evaluated whether targeted training could strengthen clinical research capacity at community cancer centers, improve readiness to conduct oncology trials, and support more inclusive patient enrollment by addressing barriers, building foundational skills, and increasing staff confidence in trial implementation.

Syed Fazle Rob, RPh

Head of Global Business development, AF Pharma Distribuce léčiv s.r.o.

Latest Article

Securing Comparator Drugs in Competitive EU Markets: Challenges and Practical Solutions

Comparator drug sourcing in the EU is shaped by a defined set of availability, regulatory, competitive, and logistical pressures, alongside practical strategies to reduce risk and protect trial timelines.

Ashley Daigneau

Head of Clinical Trials at Verana Health

Latest Article

Proactive Planning is Key to Mitigating Study Rescue

Leveraging real-world data and AI-driven insights in clinical trial planning can reduce enrollment failures, improve retention, and prevent costly rescue studies by providing a more accurate view of patient populations and site feasibility.

Sowmyanarayan Srinivasan, Tanvi Vedhera, Garima Prashad, and Vishakha Sharma
Latest Article

Leveraging Technology for Efficient Trial Design

Teams must work together with technology solutions and optimize integration to unlock their full potential.

Kenton Zavitz, PhD

Director, Clinical Affairs, Cambridge Cognition

Latest Article

The Importance of Using Cognition as an Endpoint in Clinical Trials

How cognitive evaluations can aid in meeting the growing demand for more comprehensive safety profiles.

Shadi Cinpinski, MHA

Director, Therapeutic Strategy, Oncology, IQVIA

Latest Article

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.

Mats Sundgren, Sarah Burge, Lars Fransson, Adriano Garcez, Joeri Holtzem, Gabi Maetzu, Thomas Metcalfe, Steve Tolle, Felix Nensa, and Joe Lengfellner
Latest Article

Unlocking Unstructured Health Data: Scaling eSource-Enabled Clinical Trials

New research finds that while eSource adoption is advancing through EHR-to-EDC workflows, scaling its impact will depend on integrating unstructured clinical data using AI, shared standards, and collaborative validation models across sites, sponsors, and vendors.