Budget negotiations, sponsor expectations, operational pressures, and burnout all remained front-and-center concerns at this year's Save Our Sites (SOS) conference. In this recap, I share key takeaways from the sessions I attended — including practical budgeting advice, sponsor “turn-offs,” and a few unbelievable (but true) sponsor horror stories — along with why gatherings like SOS still matter for the site community.
- The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
- Avoid Clinical Alignment Breakdowns With "Lateral Agility"
- Why Africa Could Be The Next Frontier For Clinical Trials
- The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board
- FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs
- How Keenova Reignited A Stalled Trial
GUEST COLUMNISTS
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![Climate Change-GettyImages-2151025853]( "Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial")
Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology TrialDiscover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.
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![AI-Artificial Intelligence in Healthcare-GettyImages-1365534802]( "The Uncomfortable Conversation: AI And Data Use In Clinical Trials")
The Uncomfortable Conversation: AI And Data Use In Clinical TrialsAI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
When A Clinical Trial Surfaces In An AI Chat, What Happens Next?AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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![Contracting, signing business investment-GettyImages-1370104932]( "The Cost Of Transactional Thinking In Clinical Research")
The Cost Of Transactional Thinking In Clinical ResearchDenise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.
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![Medical cloud technology, digital healthcare data storage, data management-GettyImages-2204263083]( "Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)")
Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
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![cloud data, cloud storage, digital health records, telemedicine technology-GettyImages-2253333942]( "Safe And Sustainable DCTs and Hybrid Trials (Part 2)")
Safe And Sustainable DCTs and Hybrid Trials (Part 2)In part two of this series, learn practical cloud architectural patterns, governance structures, and operating mechanisms that allow sponsors to run hybrid and decentralized trials.
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![Hospital management meeting-GettyImages-1134045124]( "Why Sponsors Should Share KPI Rationale With Sites")
Why Sponsors Should Share KPI Rationale With SitesTo build partnerships, foster transparency, and promote shared accountability, Curo Research CEO Amy Bland explains why sponsors need to communicate the utility of KPIs with sites.
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![Parkinson's symptoms-GettyImages-1688988054]( "Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial")
Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA TrialAlterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).
CLINICAL TRIAL WHITE PAPERS
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![IRT Getty 1407865352]( "Unique IRT Implementation Considerations For Personalized Medicine Trials")
Unique IRT Implementation Considerations For Personalized Medicine TrialsThe rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.
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Biopharma Reaping Numerous Benefits From AI2/18/2026
Multiple AI use cases with significant impact have been identified, and they are expected to drive innovations in clinical trials, precision medicine, and commercial operations.
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Pharma R&D Review 2024: Pleasant Weather Ahead5/16/2024
Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.
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Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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Global Trial Disclosure Landscape Grows Increasingly Complex4/15/2025
The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
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What Is ICH GCP, And How Does It Impact Clinical Planning?10/20/2025
The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Reframing Clinical Vendor Selection7/2/2025
Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives6/5/2024
Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.
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Optimizing Recruitment For Urgently Needed Vaccine5/15/2024
Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.
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End-To-End Inventory Control Supports Biotech's Expanding Portfolio2/19/2026
Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.
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Achieving A 2.67x Reduction In Study Build Time For An Innovative Neuromodulation Study12/20/2024
This study explores the potential of Focused Ultrasound Neuromodulation in deepening meditative states, and the platform that helps enhance the overall experience for researchers and participants alike.
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How A Biotech Startup Transformed Their Clinical Trial Supply Management2/25/2026
Don’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
NEWSLETTER ARCHIVE
- 03.11.26 -- Mobile Health Exhibit Bringing Clinical Trial Education To Communities
- 03.11.26 -- STREAM Edition: Policy By Press Release Is Now A Real Problem
- 03.10.26 -- When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
- 03.09.26 -- Expanding Influenza Study Access Via Community-Based Research
- 03.06.26 -- How Regulatory Convergence Is Rewriting Clinical Data Management
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.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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![Dietitian holding diet plan-GettyImages-1425188874]( "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.
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![Woman using smartwatch-GettyImages-2248203064]( "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.
FOCUS ON PATIENTS
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![Father playing with child-GettyImages-1567083882]( "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.
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![Dietitian holding diet plan-GettyImages-1425188874]( "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.
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![Woman using smartwatch-GettyImages-2248203064]( "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.
