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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![Teenager-with-depression-iStock-507801456]( "A Guide To Digital Endpoints In Major Depressive Disorder")
A Guide To Digital Endpoints In Major Depressive DisorderThe integration of digital health technologies (DHTs) in clinical trials for Major Depressive Disorder (MDD) is transforming how symptom severity and treatment efficacy are measured.
-
Completed Clinical Trials Continued To Climb In 20246/19/2025
Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
-
Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps7/7/2025
Modernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.
-
Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
-
A New Approach To Dynamic Clinical Oversight With Centralized Insights7/10/2025
RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.
-
Pharma R&D Annual Review Supplement: New Active Substances4/15/2026
Last year was by some distance the best year ever in terms of new active substances. Explore the 105 new debuts that easily outstrips that of the previous record holder, 2021’s, 97.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
-
Use Of Epiontis ID In A Phase 2 Psoriasis Trial9/25/2025
Mirikizumab’s Phase 2 trial explores IL-23 inhibition in psoriasis, measuring immune cell changes to assess its potential for long-term disease control and flare-up prevention.
-
Inspection Facilitation Without Local MAH Presence5/26/2026
Local expertise and centralized oversight ensured compliant, well‑coordinated inspections across countries, reducing operational risk and client burden while maintaining consistent authority engagement.
-
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.
-
Guiding GLP-1 Participants Through The Challenge Of Retention12/4/2025
Learn how remote lifestyle coaching can combat high dropout rates in metabolic research by offering the support participants need to maintain adherence and ensure data integrity.
-
Rescuing A Global Program For NDA Success8/12/2025
Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
NEWSLETTER ARCHIVE
- 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
- 10.29.26 -- Regulators Tighten Scrutiny While Too Many Vendors Strain Study Execution
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.
-
![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.
-
![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?
-
![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
-
![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.
-
![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.
-
![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
