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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.

Gillian Bowden
Gillian Bowden

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.

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.

Deborah Phippard, PhD
Deborah Phippard, PhD

Chief Scientific Officer, Precision for Medicine

Latest Article

Avoiding Pitfalls When Every Patient Becomes a Readout

How to generate reliable Phase I evidence in a capital-constrained environment.

Nicholas Jacobus
Latest Article

Incyte Announces Week 24 Results from TRuE-AD4 Phase III Trial of Opzelura

Incyte reports sustained 24-week efficacy and consistent safety data for Opzelura cream in moderate atopic dermatitis, supporting growing interest in nonsteroidal topical therapies for long-term disease control.

Bill Beldham

VP of Global Sales, PayQuicker

Latest Article

What Clinical Trials Can Learn from the Gig Economy About Payments

Outdated payment methods like prepaid cards and checks create administrative burden and retention friction, but modern flexible payment platforms with multiple payout options and global reach can improve participant experience without adding compliance complexity.

Devin Ridgley, PhD

Director, Project Management, Medical Device and Diagnostics Research, 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.

Inger Ødum Nielsen, Vanessa de Langsdorff, and John April
Latest Article

How Medical Writing and Regulatory Affairs Professionals Can Embrace and Deploy Generative AI at Scale

Unlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure.

Christine Senn, PhD, FACRP

Senior Vice President of Site-Sponsor Innovation, Advarra

Latest Article

2025 SCRS Global Site Solutions Summit Recap: Moving to True Partnerships

In this special recap of the most recent SCRS Global Site Solutions Summit, we highlight insights gained from KOLs on-site that emphasize the importance of communication and collaboration between sites and sponsors/CROs.

Niranjan Andhalkar

Director, Strategic Management & Planning, ProRelix Research

Latest Article

Risk-Based Monitoring in Global Clinical Trials: What Sponsors Must Know

Risk-based monitoring requires integrated data systems, validated analytics, and strong governance to work effectively across global trials, but sponsors face significant technical and operational challenges that demand strategic solutions and organizational alignment.

Joanna Williams
Joanna Williams

Chief Operating Officer, Mintra Health

Latest Article

When the Slack Runs Out: AI and the CRO Operating Model

Agentic AI will put the CRO operating model to the test—and force the efficiency and accountability questions the industry can no longer avoid.

Afrah Shafquat

Senior Staff Data Scientist, Medidata Solutions

Latest Article

Accelerating Breakthroughs with Synthetic Clinical Trial Data

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

F Sandesh Vijohar, MD; Nailesh Patel, PhD; Chirag Shah, PhD; Devanshee Patel, Pharm D; Mustafa Pardiwala, PG; and Raj Kumar, MBA
Latest Article

Overcoming Operational Challenges in Oncology Clinical Trials: Lessons from a Multicentric Study in India

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

Brad Cunningham

Head of Strategic Partnerships at Verana Health

Latest Article

Tokenization: The Unsexy Plumbing of Clinical Research

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

Ken McFarlane

Vice President, Strategic Consulting, CluePoints

Latest Article

How AI and Advanced Statistics Are Helping Research Rise

Clinical Trials Day is an international celebration of everyone who makes medical discoveries possible. It is also an opportunity to shine a light on the innovations helping to keep research rising.

Natalie Marquess, ARM, CIC, CRM

Director - Business Development, Life Sciences at Aon

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.

Farrell Healion

Founder and Principal Consultant, OptiTrial


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.

Sylvain Berthelot
Sylvain Berthelot

Host, On One Condition podcast

Latest Article

Beyond Patient Centricity: What Rare Disease Research Gets Right

Patient-centricity remains largely consultative in most clinical research, yet rare disease communities demonstrate that genuine partnership from protocol inception improves feasibility, reduces unnecessary burden, and identifies outcomes that matter to patients themselves.

Kristin Tolbert

Associate VP of Health Equity Strategy at Jumo Health

Latest Article

Pregnant Women: An Underrepresented Group in Clinical Trials

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

Cindy Henderson

Chief Strategy Officer, Veristat

Latest Article

Navigating Complexity: Strategies to Accelerate Modern Clinical Trials

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

Marc Blaustein
Marc Blaustein

Tufts Center for the Study of Drug Development, Tufts University School of Medicine

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.

Kenneth Kaitin, PhD

Professor of Medicine at Tufts University School of Medicine and Senior Fellow and former Director of the Tufts Center for the Study of Drug Development

Latest Article

Recognizing and Addressing the Execution Translation Gap in Clinical Trials

The execution translation gap—the failure to convert identified problems into coordinated, timely action—costs millions per trial through delayed amendments, persistent deviations, and slow site activation, yet remains addressable through aligned accountability and proactive execution management.

Frederic Blais, PhD

RBQM lead (strategic consulting team), CluePoints

Latest Article

Safety Reporting in RBQM: Bridging Risk Assessment, Monitoring, and Action

Safety monitoring generates substantial signal volume across risk-based quality management tools, but only 30% to 36% of signals correspond to confirmed issues, suggesting the need for better prioritization, signal consolidation, and alignment between detection and proportional action.

Mike Hutton, PhD

Director of Strategic Partnerships and Commercialisation at Almac Clinical Technologies

Latest Article

Retention by Design: Operationalizing Patient-Centric Trials Without Increasing Site Burden

The quest to turn patient retention from a chronic challenge into a competitive strength—and one that benefits all stakeholders.