Dan Schell
Verified
(He/Him)
Covers:
Clinical trial operations
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Retail technologies, data collection technologies
Articles by Dan Schell
AI Saved Time. Employees Didn't Feel It.
By Dan Schell, Chief Editor, Clinical Leader I was excited to attend this year’s Veeva R&D & Quality Summit in Boston. Unfortunately, an ankle injury two days before the conference landed me on crutches and put the kibosh on my travel plans. Not exactly the kind of disruption I expected to be dealing with that week.
10.27.26 -- Sponsors Choosing Trial Tech Are Overlooking Important Factors
CLINICAL TRIAL TECHNOLOGY Founders, Fortitude, And Clinical Trials After talking with six clinical trials-related company founders, I came away admiring the tenacity, fortitude, and curiosity it takes to turn an idea into a business — and keep it going through setbacks, uncertainty, and constant change. Choosing RTSM? Evaluate The Team Running It, Not Just The Software High-performing RTSM requires more than just code.
10.23.26 -- How One Sponsor Rescued A Trial Mid-Study — Plus 6 Steps To AI-Ready Data
Get Ready For Regulators With This Speed-Quality-Compliance Framework Part two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations. More Than A Copilot: Agentic Clinical Monitoring In Action Clinical monitoring is one of the most resource-intensive and costly parts of a trial, but it’s also one of the biggest opportunities for transformation.
Founders, Fortitude, And Clinical Trials
By Dan Schell, Chief Editor, Clinical Leader When I first started working for this company nearly 27 years ago, I was writing about resellers of technology solutions. These were mostly small businesses; many with less than 10 employees. I’d write about the challenges and struggles they went through, often just from running “a” business, not any type of business.
10.14.26 -- Can We Make Feasibility More Realistic?
Join our webinar on October 22, 2026, at 11 AM ET to learn how to successfully execute adaptive trials. We will explore key impacts on sites, data, technology, supply, and teams. Don't let adaptation turn into disruption—register today to secure your spot! Registration is free. Can We Make Feasibility More Realistic?
What I Heard When I Crashed Three ING Dive Teams
By Dan Schell, Chief Editor, Clinical Leader The Innovation Network Gathering (ING) is one of my favorite industry events for several reasons, not the least of which are its Dive Teams. These small, collaborative groups bring together people from across clinical research to tackle some of the industry's more persistent challenges. Last year, I participated in one Dive Team. This year, the conference organizers gave me permission to pop in and out of three different teams.
10.08.26 -- Regulatory Readiness From Phase I Onward
Join our webinar on October 22, 2026, at 11 AM ET to learn how to successfully execute adaptive trials. We will explore key impacts on sites, data, technology, supply, and teams. Don't let adaptation turn into disruption—register today to secure your spot! Registration is free. With CROs, Decide What You Can Actually Manage Industry veteran Peter Fredette explores how small biotechs can rethink CRO outsourcing by balancing cost, operational needs, and internal oversight.
Can We Make Feasibility More Realistic?
By Dan Schell, Chief Editor, Clinical Leader I host seven Clinical Leader Live webinars this year, and I didn’t expect our recent feasibility discussion to solve … well, any problem the industry has wrestled with for decades. Instead, From Feasibility To Reality: Will Your Trial Actually Enroll? offered something more modest: ways to challenge the assumptions behind an enrollment forecast and perhaps make a few practical improvements.
10.05.26 -- Why Are We Still Talking About Compensating Research Participants?
Clinical Leader’s Site Solutions Expo on October 7, 2026, will showcase solutions that help clinical trial sites manage growing operational demands. Attendees will learn about site activation, recruitment, patient support, payments, communication, and other services designed to reduce site burden and improve trial performance. Solution providers will demonstrate how their offerings can help sponsors, CROs, and sites execute clinical studies more effectively.
10.01.26 -- Health Policy Is Shifting Fast — Is Your Compliance Strategy Keeping Pace?
Get more clinical research insight with our FREE newsletter Newsletter | October 1, 2026 Webinar: Operationalizing Adaptive Design for FDA's One-Trial Era The FDA’s 2026 One-Trial pathway is changing how sponsors approach pivotal trial design. In this webinar, Veristat’s adaptive design experts explore the statistical frameworks, regulatory strategies, and practical considerations for building a defensible single pivotal trial.
With CROs, Decide What You Can Actually Manage
By Dan Schell, Chief Editor, Clinical Leader Peter Fredette and I spent the first 10 minutes of our interview talking about music. We’re both musicians, and although we had never spoken before, that discovery sent us down a rabbit hole before I finally remembered I was supposed to be interviewing him about CROs. As it turned out, the detour probably helped.
09.30.26 -- Old Trial Playbooks Are Breaking Under New Complexity
Get more clinical research insight with our FREE newsletter Newsletter | September 30, 2026 Join our webinar on October 22, 2026, at 11 AM ET to learn how to successfully execute adaptive trials. We will explore key impacts on sites, data, technology, supply, and teams. Don't let adaptation turn into disruption—register today to secure your spot! Registration is free.
09.29.26 -- Sponsors Are Rethinking Payments, eSource, And Study Design — Are You?
Get more clinical research insight with our FREE newsletter Newsletter | September 29, 2026 CLINICAL TRIAL TECHNOLOGY Before Adding AI, Fix The Process Regeneron’s Kaniel Cassady argues that “doing more with less” in clinical development should start with questioning existing processes, unnecessary data collection, and outdated workflows before turning to AI and other new technologies. The New Reality Of Clinical Trial Payment Workflows Outdated trial payment processes create costly delays.
09.24.26 -- Why ING Feels Different
Get more clinical research insight with our FREE newsletter Newsletter | September 24, 2026 Webinar: Speed Meets Precision: Accelerating Oncology with Smarter Data Oncology trials are generating more complex data than ever, increasing pressure on sponsors to move faster without compromising quality. Join oncology leaders as they explore how real-time data, AI-enabled analytics, and connected teams are transforming clinical development.
Small Biotech Can Outsource The Work, But Not The Thinking
By Dan Schell, Chief Editor, Clinical Leader Robert Goldman I’ve known Robert Goldman for about three years, and if you’ve ever met him, you probably know that asking him a question rarely produces a cautious, carefully hedged answer. That’s one of the reasons I enjoy talking with him. Goldman, VP of clinical development at Contraline, recently took that same approach to the stage at OCT Southern California.
09.22.26 -- Sponsors Take Control: Faster Builds, Cleaner Data, Audit-Ready Trials
Get more clinical research insight with our FREE newsletter Newsletter | September 22, 2026 CLINICAL TRIAL TECHNOLOGY What SIP Gets Right And Where It Still Falls Short SIP users Sophie Haynes and Vicki Alvarez identify features that provide value but question whether the platform eliminates enough work to justify its setup demands, repetitive processes, and usability challenges.
Before Adding AI, Fix The Process
By Dan Schell, Chief Editor, Clinical Leader Before DPHARM, I spoke with Kaniel Cassady, Ph.D., executive director, Clinical Science Strategy and Excellence at Regeneron, about the senior leadership panel he was scheduled to join on “doing more with less” in clinical operations. With six people on the panel, Cassady knew there was no guarantee every point he wanted to make would find its way into the conversation. So, I asked him what he would talk about if given the opportunity.
09.12.26 -- Beyond Reviewing Data: RBQM And EDC Integration
Get more clinical research insight with our FREE newsletter Newsletter | September 12, 2026 AUGUST'S BEST FEATURED EDITORIALS Rebecca Jackson: EHR-To-EDC Needs A Reality Check Rebecca Jackson offers a candid reality check on EHR-to-EDC integration, AI, and clinical trial technology, arguing that innovation must solve real operational problems — not create new ones.
Why ING Feels Different
By Dan Schell, Chief Editor, Clinical Leader I have been to enough clinical trial conferences to recognize the familiar formula: hotel ballroom, crowded exhibit hall, packed agenda, and attendees quietly calculating when they can get to the next meeting or reception. The Innovation Network Gathering (ING) was born from frustration with that formula. During a recent preview of the Oct.
What SIP Gets Right And Where It Still Falls Short
By Dan Schell, Chief Editor, Clinical Leader After three articles about the Shared Investigator Platform (SIP), I’ve talked to some of the people who conceived it, some who helped build it, and current users who explained why the industry’s site-technology problem is bigger than SIP itself. In Part 1, I looked at SIP’s original vision and the problem its architects were trying to solve. Part 2 explored what happened when that vision had to become an actual technology platform.
The SIP Problem Is Bigger Than SIP
By Dan Schell, Chief Editor, Clinical Leader If you thought I was going to write a series about SIP and not talk to the people who are actually using today, well … you were wrong. If you’re late to the party, in Part 1, I spoke with three members of the original TransCelerate team about the problem they were trying to solve when creating this application. In Part 2 I spoke to two more original SIP architects and went deeper into the design and implementation challenges that followed.
08.31.26 -- Compassion Shaping Pediatric Rare Disease Trials
Get more clinical research insight with our FREE newsletter Newsletter | August 31, 2026 Webinar: What’s Working in AI-Enabled Respiratory Trials: From Recruitment to Site Readiness Respiratory clinical trials face growing challenges, from shrinking patient populations and complex protocols to competition for patients and sites. How can AI and digital solutions help?
Building SIP Was The Hard Part
By Dan Schell, Chief Editor, Clinical Leader This is Part 2 of a four-part series. You can read Part 1 here. In Part 1 of this series on the Shared Investigator Platform (SIP), I spoke with Jackie Kent, Lisa Moneymaker, and Jeanette Teague about an idea that was remarkably ambitious for its time: get competing pharma companies to agree on common processes and create a shared environment that could eliminate some of the repetitive work being pushed onto clinical trial sites.
The Big Idea Behind The Creation Of SIP
By Dan Schell, Chief Editor, Clinical Leader I’ll admit; I was conflicted when I decided to write about the Shared Investigator Platform (SIP). After all, this is a company’s (Cognizant) product, and I don’t write about vendors. I also don’t want to ever seem like I’m promoting or, conversely, disparaging any company’s product or service.
08.14.26 -- RBQM Ownership, Endpoint Safeguards & Early Immunology Insights Await
Webinar: AI Reality Check in Drug Development: What’s Real and What’s Missing AI is advancing drug discovery and development, but realizing its full potential depends on reliable, high-quality clinical data. Join Dr. Richard Graham, co-founder of TruTechnologies, and industry experts as they explore where AI is delivering value today, where challenges remain, and how sponsors can build the foundation for more effective AI-driven decisions across the drug development lifecycle.
08.12.26 -- Smarter Trials Don't Happen By Accident
Join Skye Hodson, VP of Clinical Solutions, on Thursday, August 20, 2026, at 11 a.m. ET to learn how trusted data and targeted AI can improve clinical trial design, planning, and execution. The session covers drivers of trial complexity, AI-supported protocol design, data-informed site selection, effective patient recruitment strategies, and alignment with evolving regulatory expectations, including ICH GCP E6(R3).
08.11.26 -- Rethink What Works In Clinical Trials: From Protocol Design To Digital Workflows
Biopharma investing today demands more than breakthrough science. Policy, pricing, reimbursement, and health economics increasingly shape a product’s value long before it reaches the market. Join investors, innovators, policy makers, and value leaders at the ISPOR Healthcare Investment Summit to gain insights that drive smarter, more resilient investment decisions.
Rebecca Jackson: EHR-To-EDC Needs A Reality Check
By Dan Schell, Chief Editor, Clinical Leader “I don’t come to work to be a politician or to make friends.” That’s not a sentence you hear very often from someone leading technology initiatives inside a major pharmaceutical company. But it perfectly captures Rebecca Jackson‘s approach to innovation. Jackson, who is associate director, global development systems at Johnson & Johnson Innovative Medicine, continued, “I come to work for the good of the patients.
08.08.26 -- Clinical Leader Newsletter - Best Of July
JULY'S BEST FEATURED EDITORIAL How Important Are Medical Monitors Under ICH E6(R3)? Discover how medical monitor-led implementation of ICH E6(R3) outperforms operations-only models across six critical performance dimensions. AI Builds Better Trials, But Patient Recruitment Remains Human AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
08.06.26 -- Development With Orphan Drug Designation And Early Talks With The FDA
IRB in Action: A Live Mock Board Review offers a behind-the-scenes look at the IRB review process through a live mock board meeting led by experienced IRB members and clinical research experts. Attendees will observe protocol evaluation, risk-benefit discussions, informed consent review, and regulatory considerations while gaining practical insights to improve IRB submissions, protocol development, and study readiness.
08.05.26 -- Decentralized, Flexible, Patient-First: The Future Of Clinical Trial Delivery
Join us on August 25th to learn how to optimize Parkinson's disease clinical trials. Experts from Dr. Vince Clinical Research and the Davis Phinney Foundation will discuss trial design, endpoint selection, patient-centered research, and operational challenges for symptomatic and disease-modifying therapies. Attendees will gain practical strategies, real-world case studies, and insights to support successful CNS drug development from early-phase studies through NDA submission.
The Rare Trials Summit Wants To Produce More Than Conversation
By Dan Schell, Chief Editor, Clinical Leader Miro Pastrnak Trust me, I know it’s easy to become cynical about industry conferences. After all, there are plenty of opportunities to listen to keynote presentations, network in hotel hallways, and collect enough business cards to last until next year’s event. That’s why the organizers of the Rare Trials Summit knew they had to create something more than just a standard conference.
07.28.26 -- When One Trial Leads To Rethinking Them All
Join Skye Hodson, VP of Clinical Solutions, on Thursday, August 20, 2026, at 11 a.m. ET to learn how trusted data and targeted AI can improve clinical trial design, planning, and execution. The session covers drivers of trial complexity, AI-supported protocol design, data-informed site selection, effective patient recruitment strategies, and alignment with evolving regulatory expectations, including ICH GCP E6(R3).
07.24.26 -- Turning RWD Into RWE That Works For Trials
The 2026 Rare Trials Summit brings together senior clinical development leaders from biopharma, FDA, patient advocacy and research sites to tackle the practical barriers slowing rare disease development. Held September 14-16 at the Boston InterContinental, the Summit combines working groups, interactive workshops, and candid discussions on evidence generation, trial design, patient engagement, endpoints, and execution.
When One Trial Leads To Rethinking Them All
By Dan Schell, Chief Editor, Clinical Leader Usually, when someone sees my name badge at a conference, they say, “Oh, you’re that guy who sends me all those emails.” (For the record, those are not coming from me personally.) Thankfully, that wasn’t what Dan Nicolau, Ph.D., said to me when we met at the Clinical Trials Technology Congress (CTTC) in London earlier this year. Instead, Nicolau, who was familiar with Clinical Leader, told me a story that quickly got my attention.
From The Lab To Regulations As An IRB Specialist
By Dan Schell, Chief Editor, Clinical Leader Ribu Goyal Talking with folks who work in clinical research at an AMC is always super interesting to me because those environments are often very different (e.g., technology used, operational/management structure) from stand-alone sites. So, when Ribu Goyal, an IRB specialist and scientific reviewer at the Mayo Clinic Office for Human Research Protection, contacted me and offered to tell the story of her journey “from lab to regulations,” I was all in.
A Role-Play Conference Session That Reframes The Data Manager's Job
By Dan Schell, Chief Editor, Clinical Leader At the Clinical Trials Technology Congress in London, I sat in on a session that turned out to be … well, super memorable. Four clinical trial professionals staged a short theatrical performance rather than delivering slides, and it ended up being the most entertaining and educational hour I’ve spent at a conference in a long time (kudos to Emma Maria Calleja of Von Peach for crafting such a creative session).
07.14.26 -- A Role-Play Conference Session That Reframes The Data Manager's Job
Why Diversity Still Should Matter Join Clinical Leader Live Chief Editor Dan Schell and his curated panelist of experts when they take a hard look at inclusivity in clinical trials and what’s holding the industry back. Learn why getting it right in 2026 isn’t optional; it’s essential for science, safety, and patients. Register for Why Diversity Still Should Matter on July 15 at 11 AM ET.
07.10.26 -- Accelerating Trial Execution With AI And Real-Time Data
The Site AI Playbook: Vendor Tools, Homegrown Solutions & What's Working This webinar examines how clinical research sites are using AI to improve operations, despite a crowded and often confusing tools landscape. Experts share a practical framework for deciding between in-house solutions, existing platforms, and specialized AI tools.
07.09.26 -- Why "Steady Evolution" Best Describes AI's Future
Why Diversity Still Should Matter Join Clinical Leader Live Chief Editor Dan Schell and his curated panelist of experts when they take a hard look at inclusivity in clinical trials and what’s holding the industry back. Learn why getting it right in 2026 isn’t optional; it’s essential for science, safety, and patients. Register for Why Diversity Still Should Matter on July 15 at 11 AM ET.
CTTC Opens With A Reality Check On AI
From The Editor | July 7, 2026 By Dan Schell, Chief Editor, Clinical Leader When I walked into the opening plenary of the Clinical Trials Technology Congress (CTTC) in London, I expected the usual AI conversations. New capabilities. New platforms. Predictions about where the technology is headed. Blah, blah, blah. So, you can imagine how relieved I was when I realized we weren't getting the same old messaging and presentations.
07.06.26 -- The Patient Recruitment Debate Nobody's Having
Why Diversity Still Should Matter Join Clinical Leader Live Chief Editor Dan Schell and his curated panelist of experts when they take a hard look at inclusivity in clinical trials and what’s holding the industry back. Learn why getting it right in 2026 isn’t optional; it’s essential for science, safety, and patients. Register for Why Diversity Still Should Matter on July 15 at 11 AM ET. What's Wrong With Site Benchmarking?
07.01.26 -- Bridging Community And Central Hospitals With Japan's DCT Model
Bridging Community And Central Hospitals With Japan's DCT Model Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan, explains consultant Takuma Matsunaga.
Why "Steady Evolution" Best Describes AI's Future
By Dan Schell, Chief Editor, Clinical Leader When I hosted a recent Clinical Leader webinar on AI in clinical trials, I expected the discussion to focus heavily on technology. Instead, much of the conversation centered on something far less glamorous: the realities of change management in an industry that has historically adopted new technologies far more slowly than outsiders often expect. The idea for the webinar came from Clinical Leader Editorial Advisory Board member Samir Shah.
06.29.26 -- Breaking Barriers In Rare Disease Clinical Trials
Smart Sourcing: Patient Recruitment & Retention Showcase, a virtual event for clinical teams to explore and compare top patient recruitment and engagement partners. Expect live, side-by-side comparisons, real-time Q&A, and practical insights to boost enrollment, diversity, and retention. Ideal for Clinical Ops, Site Engagement, and Vendor Management teams. Leave with a vetted shortlist of partners and actionable takeaways—without the time, cost, or travel of traditional conferences.
06.25.26 -- An Inside View Of The Clinical Trials Technology Congress
A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI Clinical tech consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change. Vendor Selection Bias: Why Structured Decisions Often Fail Learn how subtle influences derail decisions and discover proven safeguards that promote transparency, accountability, and shared ownership for better trial outcomes.
Where Are We With Clinical Trial Tokenization?
From The Editor | June 19, 2026 By Dan Schell, Chief Editor, Clinical Leader Back in January 2024, I interviewed Tom Dougherty about a topic many clinical research professionals had heard mentioned but few could confidently explain: tokenization. More than two years later, that article remains one of the most-read pieces ever published on Clinical Leader. Why? Well, I’d be guessing, but I think it’s because tokenization is one of those topics that seems to get more relevant every year.
06.18.26 -- From Scorecards To Strategy: Advancing Clinical Trial Partnerships
3 Views From Inside FDA's RTCT Pilot The FDA's RTCT pilot promises to bring clinical trials into the real-time era, but questions remain about governance, oversight, and implementation. We asked three organizations participating in the initiative what they see as the opportunities, challenges, and realities behind the FDA's most ambitious modernization effort in years. Capture Was Step One.
06.17.26 -- Reducing Complexity Across The Clinical Trial Lifecycle
The Rise — And Stall — Of Retail Pharmacy Clinical Trials As rumors swirl that Walgreens may be reassessing its clinical trials business, this article explores a broader trend: why major retail pharmacy chains like CVS, Walmart, and Kroger have struggled to make the model work at scale.
06.16.26 -- Turning Clinical Data Into Operational Advantage
Driving Faster Clinical Trial Setup: How Humans and AI Collaborate to Improve Quality, Speed, and Agility in Study Build Study build delays stem from fragmented protocol interpretation, manual setup, and late stage validation issues—not a single failure point. This webinar shows how human–AI collaboration can streamline the full build lifecycle, reduce rework, improve consistency, and surface issues earlier while preserving control and quality. Click here to learn more.
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