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Forget More Clinical Tech, We Need More Adoption

At SCOPE Summit, Craig Lipset shared a blunt assessment of clinical trial innovation: the tools exist, regulators are engaged, and digital approaches offer clear quality advantages — yet adoption remains the industry’s biggest hurdle. From evolving FDA inspection expectations to the normalization (and lingering misconceptions) of decentralized trials, Lipset argues progress will depend less on new technology and more on scaling what already works.

GUEST COLUMNISTS

When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
Learn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).
FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now
On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.
How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)
Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.
How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)
Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.
These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials
Minovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.
Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
What ChatGPT Ads Will Really Mean For Clinical Trials
AI health assistants may be used to surface clinical trials earlier in patient journeys, and advertising inside conversational AI is best understood as the next logical step in that same progression.
The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?
Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.

CLINICAL TRIAL WHITE PAPERS

Guide To Pharmaceutical CAPA And Quality Management
CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.

Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?
10/20/2025

Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
Addressing Trial Design Hurdles Across Alzheimer’s Disease Stages
12/10/2025

Explore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
A Guide For Quality Professionals In Healthcare And Life Sciences
3/14/2025

Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.
Modernizing Clinical Trial Oversight: The Path To Clinical Operations Excellence
8/4/2025

Examine the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.
Proving The Return On Investment For eRegulatory
1/22/2025

Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Consolidating Clinical Supply Chain Operations With GxP Inventory
4/18/2024

A Japan-based biotechnology company leveraged Signant SmartSignals® GxP Inventory, which improved visibility, reduced risks and costs, and optimized operations in this case study.
Driving A High-Adherence LTFU Trial Without An EDC
10/29/2025

Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.
Rare Disease Prioritization Model And Landscape Analysis
3/15/2024

Uncover how a global pharmaceutical company seeking to identify promising indications among rare diseases to develop preclinical candidate molecules received an in-depth disease analysis to guide its strategic decision-making.
Analytics–Powered Approach To Patient Recruitment Strategy
7/15/2025

In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
Breaking Down Operational And Financial Complexity In Clinical Trials
12/8/2025

Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.
Redefining Accessibility For Pediatric Patients
9/24/2025

Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

RECRUITMENT AND DIVERSITY

This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.

The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
4 Steps For Representative Enrollment In Rare Disease Trials

Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.

FOCUS ON PATIENTS

Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease

The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.