P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
- Small Biotech Can Outsource The Work, But Not The Thinking
- The Real Cost Of Sites Working Without An Enforceable Agreement: Why Your Site's Quality Of Earnings Is Suspect
- The U.S. Clinical Trial Recruiting Pipeline Report – August 2026
- How VNS-REHAB Aims To Improve Stroke Recovery After Patients Have Plateaued
- Resensitizing Treatment-Resistant Cancer Holds Promise Over Replacing Once-Efficacious Therapies
- Why Oncology Programs Can't Rely On An Inside View Alone
- In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
GUEST COLUMNISTS
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![business man looking through telescope-GettyImages-2215651052]( "Why Oncology Programs Can't Rely On An Inside View Alone")
Why Oncology Programs Can't Rely On An Inside View AloneDiscover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
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![Fda Headquarters-GettyImages-2211199138]( "In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies")
In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene TherapiesI review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.
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![Mixing medications-GettyImages-907865696]( "Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy")
Repurposing Three FDA-Approved Drugs For A New Stroke Recovery StrategyWhen three drugs become one — the polypharmacology strategy, 505(b)(2) pathway, and objective endpoints Nuero-Innovators is relying on to bring new hope to stroke patients.
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![CMT main image-GettyImages-2210725149]( "Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New Guidance")
Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New GuidanceA new Charcot-Marie-Tooth guidance introduces practical recommendations to help sponsors design clearer, more patient-centered, regulator-ready trials.
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![healthcare workers collaborate-GettyImages-2257620029]( "How AI Will Reshape Study Start-Up")
How AI Will Reshape Study Start-UpAI can help study start-up teams move from tracking delays to predicting risks—if human judgment, data quality, and governance stay central.
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![online document verification, file management, data storage-GettyImages-2265259381]( "Clinical Supply Systems Need IT General Controls")
Clinical Supply Systems Need IT General ControlsValidating a clinical trial system does not prove it stays trustworthy. IT general controls can protect data, supply decisions and patient safety long after go-live.
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![metal chain-GettyImages-638503806]( "Medical Affairs: The Missing Link To Oncology Drug Adoption")
Medical Affairs: The Missing Link To Oncology Drug AdoptionLearn how medical affairs can help oncology teams turn strong clinical evidence into real-world adoption by connecting development strategy with clinical practice.
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![Teamwork, collaboration-GettyImages-2218614336]( "How Can We Influence Others For Better Outcomes In Clinical Research?")
How Can We Influence Others For Better Outcomes In Clinical Research?Learn how to use the Delphi method to build consensus and drive better decisions in clinical research — even when stakeholders start far apart.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-912073314 In Home Nurse]( "Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps")
Continuous Cough Monitoring: Addressing Placebo Effects And Data GapsModernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.
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Proving The Return On Investment For eRegulatory1/22/2025
Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.
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Remote Patient Monitoring Using Mobile Health Technology3/28/2025
This study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.
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Ensuring A Diverse Patient Population In Clinical Trials12/13/2024
In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.
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Go From Three Meetings To One With AI-Enabled eCOA5/5/2026
Learn how to turn three meetings into one with AI that is streamlining clinical workflows by reducing redundant steps, simplifying site operations, and accelerating data collection.
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Faster Starts, Stronger Finish: Operational Excellence In NSCLC5/22/2026
In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Scaling Investigational Drug Services: A Case Study in Overcoming Operational Bottlenecks8/20/2026
Are operational bottlenecks holding back your research site? Explore a blueprint for automating investigational product workflows and giving staff time back for patient care.
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NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission8/12/2025
A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).
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How A Biotech Startup Transformed Its 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.
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When Every Hour Counts: Emergency Transfer Protects Critical Biomedical Materials8/10/2026
Rapid deployment of specialized cold chain logistics and cryogenic assets ensures strict temperature compliance, protecting critical research continuity and preventing catastrophic material loss.
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
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Study Analysis – Site Payment Automation12/8/2025
By removing administrative bottlenecks, see how automation improves cash flow for sites, reduces operational burden for sponsors, and supports smoother, more predictable trial execution.
NEWSLETTER ARCHIVE
- 09.25.26 -- Sponsors Trust AI To Match Patients — But Risk Still Needs Human Eyes
- 09.25.26 -- Stop Chasing Documentation. Let Trial Software Catch Up Instead
- 09.24.26 -- Why ING Feels Different
- 09.23.26 -- Overcoming Enrollment Barriers And Navigating Decentralized Trial GCP Requirements
- 09.23.26 -- Why Specialty Samples And Protocol Choices Are Putting Trials At Risk
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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![International Womans Day-GettyImages-2259815511]( "Autoimmune Drugs For Women: What To Bring To The Clinic")
Autoimmune disease is one of the most sex-skewed categories in medicine. Sex, reproductive status, and hormonal state should not be treated as background noise.
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![jackson AI part 2 using-GettyImages-2192428169]( "Turn AI Visibility Into Action: Build Explanation Layers For Different Stakeholders")
AI visibility isn’t just about being found. Ross Jackson coaches sponsors on how to influence AI to provide clear stakeholder pathways for clinical trial involvement.
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![online question and answer, problem-solving, and digital communication-GettyImages-2241803274]( "Your Trial Shows Up In AI. Now What?")
AI can explain your trial — but can it help patients act? Ross Jackson shares how sponsors can turn visibility into trust and next steps.
FOCUS ON PATIENTS
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![business man looking through telescope-GettyImages-2215651052]( "Why Oncology Programs Can't Rely On An Inside View Alone")
Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
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![Risk Assessment-GettyImages-2192813165]( "The Promise Of MRD-Guided CAR-T Treatment")
Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.
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![pharmacist, service, guidance, patient care-GettyImages-2260105068]( "The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option")
Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
