Brazil’s clinical research transformation takes center stage as this new Q&A series opens with Interfarma CEO and former ANVISA director Renato Porto.
- 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
- Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source
- Who Owns Your Clinical Trial Software When The Vendor Leaves?
- What The New PDUFA Guidance Means For Drug Development
GUEST COLUMNISTS
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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.
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![psychology, counseling-GettyImages-2274786993]( "Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?")
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.
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![Lab Experiment-GettyImages-157697835]( "The U.S. Clinical Trial Recruiting Pipeline – September 2026")
The U.S. Clinical Trial Recruiting Pipeline – September 2026This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from August to September.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1326241306-research-computer-brain-scan]( "ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations")
ICH GCP E6(R3) Implementation: Practical Approaches And Real-World ConsiderationsAccess 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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Phase 1 Clinical Trial Designs And Strategies9/18/2025
With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
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UK Clinical Trial Regulations Reform7/24/2026
UK trial regulations have been overhauled. Learn what faster approval pathways, stricter publication rules, and longer retention requirements mean for your operations.
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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.
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Rapid Expansion Of Peptide And Nanobody Drug Conjugates7/21/2026
Peptide and nanobody drug conjugates are gaining momentum, with 106 active programs identified globally. Learn more about the fast-evolving space for targeted drug delivery and competitive opportunities.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Changing The Clinical Feasibility Game With AI1/22/2026
AI is only as good as the data it’s built upon. Our customized AI platforms are constructed on a foundation of trustworthy, carefully curated data to produce detailed, expert-driven responses.
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Advancing Oncology Innovation With Adaptive Trial Designs8/12/2025
When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.
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Advancing IHC Assays From RUO To Clinical Trials And CDx8/21/2026
Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.
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Breaking Free From Process Paralysis In Clinical Trials1/13/2025
Explore the implementation of CRIO’s eSource solution by a leading pharmaceutical company to overcome process paralysis in clinical research.
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Enhance Access And Improve Retention In Rare Disease Trials With HTS4/17/2025
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
NEWSLETTER ARCHIVE
- 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
- 10.29.26 -- Regulators Tighten Scrutiny While Too Many Vendors Strain Study Execution
- 10.28.26 -- The U.S. Clinical Trial Recruiting Pipeline – September 2026
- 10.28.26 -- Feasibility Isn't Just A Technology Problem
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
