Articles By Dan Schell, Chief Editor
DAN SCHELL ARTICLES
PI's CRAACO Model + AI = Rapid Enrollment
At Dr. David Almeida’s clinical trial site in Erie, PA, he practices the CRAACO model exclusively, relying on the revenue he makes from conducting clinical trials for eye-related diseases. To minimize his costs and speed up trial enrollment, he uses a proprietary AI system that has given him an 85% screen-to-enroll ratio.
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25 Tips To Prepare A Clinical Site For FDA Inspection
During the last year I have interviewed six former FDA investigators and a regulatory expert who has been involved with more than 250 inspections. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection.
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Insights From 250+ Regulatory Inspections
Elisabeth George, who has led more than 250 FDA inspections, shares practical advice for hosting audits — including preparation tips, team coordination, live documentation, and knowing exactly when to speak.
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Why Perfect Clinical Trial Data Is A Dangerous Myth
Former FDA inspector Kara Harrison reveals clinical trials fail due to overcomplex designs, checklist-driven monitoring that misses critical issues, and lack of focus on what actually matters for patient safety and data integrity.
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Here's Your 483 — And Your Hug
Former FDA inspector Tracey Harris shares what clinical sites get right, what they botch completely, and why inspection readiness is about more than coffee, binders, or bluffing.
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Spiders, Mold, & SOPs: Tales From A Site Inspection Veteran
Sarah Moeller, a veteran of mock regulatory inspections, shares lessons from over 300 site visits, emphasizing preparation, documentation, and patient-focused practices to ensure sites are inspection-ready.
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U.K. Has Strong Plan To Reform Clinical Trials
The U.K.’s 2025 clinical trial reforms aim to boost research efficiency, inclusivity, and global competitiveness by streamlining approvals, enhancing patient involvement, and addressing structural, demographic, and therapeutic gaps in trial activity.
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Local HCPs In DCTs: A Game-Changer For Oncology Trials
An AMC’s decentralized trial model uses local HCPs to expand oncology research access across North Carolina while maintaining regulatory compliance and building on early DCT experiences and FDA collaboration.
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7 Steps To Manage Local HCPs In A Decentralized Trial
Here’s a template you can use for a multi-step process to create a centralized system to verify the credentials, licenses, and professional standing of all local healthcare professionals (HCPs) participating in a DCT.
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Local HCPs in DCTs: Big Benefits, Bigger Burdens?
Local HCPs in DCTs provide benefits like improved patient accessibility, retention, and diversity, but create significant oversight burdens for investigators and sponsors, requiring extensive documentation, training protocols, and communication systems to maintain compliance.
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The Evolution Of A Clinical Research Coordinator
Briana White is a CRC with Superior Clinical Research, a small clinical research site in Smithfield NC. She talks about how she got into the clinical industry and what she struggles with in her job (spoiler alert: it involves tech).
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Being Financially Prudent As A Site Isn't a Bad Thing
Most sites are composed of three silos of people who rarely cross communicate -- especially about issues that could affect finances. But if your job is to take care of patients. should you be concerned about the same things as your finance-related colleagues? Dr. Daniel Fox says, at the very least, you should be communicating some key events/milestones.
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Did The SOS Conference Suffer From A Sophomore Slump?
You’d be making a big mistake if you felt the Save Our Sites conference was too small to attend or exhibit at. You also may be misinformed if you’ve been told this show is simply a forum for small sites to complain about being treated unfairly. After attending for the first two years, I’d say this is one to keep on your radar. Here’s why.
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Takeda's Diversity Strategy Pays Off For Phase 3 Trial
LaShell Robinson, head of global feasibility and trial equity at Takeda explains how the company’s Phase 3 trial for a psoriasis drug ended enrollment well before it’s goal and achieved some impressive diversity metrics.
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What ClinOps Wants To Know About AI
Registrants for our recent Clinical Leader Live, “AI In Action: Transforming Clinical Trials,” were asked what they wanted to learn after watching the webinar. We thought it would be interesting to look at the five general themes to the types of questions they were asking.
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The Scoop On SCOPE
Chief Editor Dan Schell summarizes some of his favorite quotes and learnings from the 2025 SCOPE Summit. Spoiler alert … Not everything is about AI these days.
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Site Networks Find Strength In Numbers With AMRC
Jim Kremidas, executive director of the newly launched Association of Multisite Research Corporations (AMRC), talks about the genesis and future of this association, which launched with 14 multisite clinical research corporations (MCRCs) members.
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We're Looking At Patient Recruitment All Wrong
Leanne Woehlke, a 30-year veteran of the clinical research industry, says our standard patient recruitment efforts are lacking one key element — a focus on the patient’s needs.
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Should You Choose An FSP Model? It Depends…
Small biotechs are often drawn to an FSP model because they believe it’s a less expensive option as compared to an FSO. But that’s not always the case, says Réne Stephens of Danforth Advisors, who gives some examples of what to consider before making your choice of outsourcing solution.
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Should We Be Scared Of PE Firms Investing In Sites?
It seems lately there's been a lot of vilification of private equity (PE) firms that are purchasing site networks. I'm sure this sentiment has increased during the past few years, but is it justified?
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Let's Fix The Tax Burden On Clinical Trial Participants
We all know that patient retention is lowered once a participant realizes the tax implications of being in a clinical trial. But taxes should be the last thing they have to worry about, so why can’t we get some changes made?
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Were There Any Surprises In Clinical Trials In 2024?
Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once? Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.
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2024: Familiar Problems & Encouraging Progress
For part 1 of my 2024 recap, I asked various industry experts what stood out to them this year regarding the clinical trials industry. They mentioned significant challenges related to site capacity, enrollment, workforce changes, and trial complexity, but they also seemed encouraged with some of the efforts and emerging solutions that will address these issues.
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Can Better Data Management Save Clinical Trials?
In this summary of our 10/31/24 Clinical Leader Live, we talk about the current ICH M11 guideline, which focuses on a clinical electronic harmonized protocol, as well as the need for data standardization and the benefits of the resulting automation. Our panelists include Jessica Jolly, a data science expert with 25 years of experience, and Hassan Kahlid, senior engineer, machine learning and data science at AstraZeneca.
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PI Insights From A Heart Failure Trial: Part 2
This is part 2 of Dan Schell’s interview with Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial. Here, she elaborates more on some of her tasks specific to this heart failure trial.
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PI Insights From A Heart Failure Trial: Part 1
Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial, talks about her role as a PI including trial design and meetings with the FDA.
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Not A Bad First Year
Dan Schell, chief Editor or Clinical Leader, summarizes his first year in this role and highlights some of his key takeaways and lists some of the people who have helped him better understand the clinical trials ecosystem.
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We Are All Project Managers, But We Need Help
Jess Thompson is a champion of project managers. Not only is she working to validate their role in the clinical trial ecosystem, she wants to spread the word that we all perform PM-types of duties. Also, if we could get better as an industry at incorporating some of those basic tenants of project management, perhaps we could see more drugs succeed — and quicker.
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Plodding Toward Better Data Integration & SSO
Laura Hilty, a principal at HealthX Ventures, talks about the need to better integrate data platforms and improve/enable single sign-on (SSO) solutions so sites can lessen their administrative burden.
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A New Barometer For Clinical Outsourcing Performance
Interested in how some of the top publicly traded clinical development outsourcing companies are doing in the market? Andrew Schafer may be able to help with his Schafer Clinical Development Index (SCDI).
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Dan Schell
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Dan Schell is Chief Editor of Clinical Leader where he writes about topics related to clinical trial operations. Previously, he served as the Editorial Director of Life Science Leader magazine, another Life Science Connect community, for 14 years. In this role, he worked with the publication’s internal and external writers and editors on choosing the best topics for articles as well as refining all content to meet Life Science Leader’s high editorial standards. Prior to his work with Life Science Leader, he worked as an editor and copy editor for the publication’s parent company, VertMarkets (now called Life Science Connect). He joined the company in 2000 after 10 years of working for Encompass Health (previously Healthsouth) in marketing and business development and four years at an advertising agency.
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