Our expert chat about Brazil’s clinical research transformation concludes with SBOC President-elect Fabio Franke, who explores building sustainable trial capacity beyond the country’s major AMCs.
- Brazil's Regulatory Transformation: A New Era For Clinical Development
- The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI
- An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
- Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWE
- AI Saved Time. Employees Didn't Feel It.
- What Happens When Clinical Trial Patients Need Care Outside Of The Study?
- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
GUEST COLUMNISTS
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![Team Blocks-GettyImages-1860565143]( "When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs")
When To Build Out Your ClinOps Team — And Other Advice For First-Time BiotechsSmall biotechs shouldn't model their ClinOps headcount after Big Pharma. Instead, they need the right capabilities, oversight, and risk controls. Consultant Jessica Cordes explains.
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![OssiumHealth11]( "Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source")
Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor SourceOssium CEO Kevin Caldwell explains how an unconventional multisite Phase 1 trial is shaping the company's novel bone marrow product’s path ahead.
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![privacy, data breach, cybersecurity-GettyImages-2214686070]( "Who Owns Your Clinical Trial Software When The Vendor Leaves?")
Who Owns Your Clinical Trial Software When The Vendor Leaves?When a clinical trial software vendor exits, sponsors still own the risk. Learn what to secure before signing a contract to protect data, validation, and continuity.
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![FDA Headquarters MD-GettyImages-2278014569]( "What The New PDUFA Guidance Means For Drug Development")
What The New PDUFA Guidance Means For Drug DevelopmentLearn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.
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![Diverse women doctors-GettyImages-2246070483]( "The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings")
The Site Landscape Is Evolving, But How? Tufts CSDD Shares New FindingsTufts CSDD data reveals how academic, independent, and network-affiliated clinical trial sites differ in growth, reach, staffing, and performance.
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![Patient ultrasound examination-GettyImages-1473904792]( "Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care")
Testing Early Treatment In Head And Neck Cancer Without Compromising Curative CareCan early APG-157 treatment control head and neck cancer without delaying curative care? A Phase 3 trial puts timing, safety, and outcomes to the test.
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![new reg part 1 - GettyImages-1366013071]( "The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?")
The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?Part one of this two-part series explores how clinical trial regulation aims to balance speed, quality, compliance, and digital innovation.
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![new reg part 2 - GettyImages-1366013071]( "Get Ready For Regulators With This Speed-Quality-Compliance Framework")
Get Ready For Regulators With This Speed-Quality-Compliance FrameworkPart 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.
CLINICAL TRIAL WHITE PAPERS
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![Business Meeting-GettyImages-1831418247]( "Accelerate Drug Development With Master Protocols")
Accelerate Drug Development With Master ProtocolsThrough careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
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Beyond The Benchmark: Innovative Trial Designs Transform Research1/15/2026
Adaptive designs, decentralized models, and AI insights are reshaping trials — boosting efficiency, speeding timelines, and strengthening evidence amid evolving regulations and funding pressures.
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Open-Label Study Assessing Relative And Absolute Bioavailability1/26/2026
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
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If Data Integrity Matters, Paper Is Not An Option3/5/2026
Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.
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Understanding Immunogenicity In AAV Gene Therapy8/14/2025
As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Scaling Success: A Blueprint For Flexible Biometrics Partnerships2/19/2026
Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
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Accelerating Recruitment In A Challenging Phase III Rare Disease Trial8/18/2026
Recruiting for rare acute diseases is challenging. Discover how this organization used rapid site activation and investigator engagement to speed enrollment in a Phase III Anti-GBM trial.
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Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
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How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
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End-To-End Clinical, Biometrics, And Regulatory Support In Neurology6/4/2026
Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.
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Psychedelic Drug Trials: Are Your Sites Ready?8/24/2026
Psychedelic trials require unique operational approaches. Learn how to address patient safety, blinding, specialized assessments, and therapeutic setting considerations.
NEWSLETTER ARCHIVE
- 11.04.26 -- What's Shaping Healthcare Value And Access?
- 11.03.26 -- Disconnected Systems Are Costing Trials Time — Here's Where Teams Are Catching Up
- 11.02.26 -- AI Can't Fix Enrollment When Payments, Sites, And Trust Break Down
- 10.30.26 -- The New Clinical Trial Regulatory Landscape Balances Speed, Quality, And Compliance — Are You Ready?
- 10.30.26 -- Services To Support Your Sites
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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![AI vs human-GettyImages-2285304527]( "The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI")
AI might find patients faster, but only people earn their trust. A site COO explains how to pair AI speed with human judgment, plus the guardrails every site should build in.
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![patient and doctor analyzing medical report-GettyImages-1461330630]( "Can A Universal Health Screening Help Stop Clinical Trial Dropouts?")
Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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![Medicine, healthcare insurance-GettyImages-1369119541]( "Participant Payment — Make It Make Cents")
Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.
FOCUS ON PATIENTS
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![Doctor using tablet in hospital-GettyImages-2227564671]( "What Happens When Clinical Trial Patients Need Care Outside Of The Study?")
Clinical trial patients may need care outside of the trial protocol. Discover how closing information gaps can protect safety, trial participation, and data integrity.
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![Patient ultrasound examination-GettyImages-1473904792]( "Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care")
Can early APG-157 treatment control head and neck cancer without delaying curative care? A Phase 3 trial puts timing, safety, and outcomes to the test.
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![psychology, counseling-GettyImages-2274786993]( "Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?")
Psychedelic-assisted treatment may offer faster, lasting relief for cancer patients facing adjustment disorder, depression, and anxiety.
EDITORIAL COLLECTIONS
Take a deep dive into the issues shaping clinical research today with our curated Editorial Collections. Each collection features expert insights and practical strategies addressing today’s biggest challenges in clinical trial planning and execution.
More Editorial Collections
