Ossium CEO Kevin Caldwell explains how an unconventional multisite Phase 1 trial is shaping the company's novel bone marrow product’s path ahead.
- What The New PDUFA Guidance Means For Drug Development
- The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings
- Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care
- Founders, Fortitude, And Clinical Trials
- The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?
- Get Ready For Regulators With This Speed-Quality-Compliance Framework
- Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?
GUEST COLUMNISTS
-
![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.
-
![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.
-
![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 Septemeber.
-
![cyber security sign-GettyImages-1070773010]( "Unlocking AI Value For Clinical Research Associates")
Unlocking AI Value For Clinical Research AssociatesClinical research associates (CRAs) have largely been late to adopt AI. CRAs who adopt it can streamline repetitive work while also freeing capacity for high-judgment work.
-
![Exclamation Symbol Blocks with Computer Mouse-GettyImages-2268428175]( "Your EDC Query Count Is Trying To Tell You Something")
Your EDC Query Count Is Trying To Tell You SomethingA rising EDC query count may reveal more than dirty data. Learn how query patterns can expose upstream problems in trial workflows, training, and CRF design.
-
![patient and doctor analyzing medical report-GettyImages-1461330630]( "Can A Universal Health Screening Help Stop Clinical Trial Dropouts?")
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?
-
![Remote work, hybrid-GettyImages-2065627473]( "Can Your Team Coordinate The CRO Model You've Chosen?")
Can Your Team Coordinate The CRO Model You've Chosen?Choosing the right CRO model matters less than a sponsor’s ability to coordinate it. Here’s how to match outsourcing strategy to internal capacity.
-
![LLM, AI Large Language Model-GettyImages-2149059417]( "To Pick The Right Medical LLM, First Assess Your Readiness")
To Pick The Right Medical LLM, First Assess Your ReadinessLearn how to evaluate medical LLMs for clinical trials by weighing readiness, risk, validation, integration, hidden costs, and supplier controls.
CLINICAL TRIAL WHITE PAPERS
-
![Woman laptop telehealth remote iStock-1214389964]( "Improving The eCOA Experience")
Improving The eCOA ExperienceDiscover how template-driven builds and reuse can slash eCOA timelines by 50% while solving the licensing and translation hurdles that delay First Patient In.
-
How Digitized Protocols Are Accelerating Clinical Research4/15/2025
Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.
-
How Sponsors Can Drive Success With Central eSource At Investigator Sites6/17/2025
Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
-
Patient-Focused Data Capture For Cancer Research8/21/2025
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
-
Enhancing Clinical Trial Flexibility9/1/2025
Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.
-
A New Era Of ADC Development Demands A New Kind Of Partner3/30/2026
Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Ergomed's Solutions To The Challenges of Oncology Trials4/15/2025
Explore a pivotal Phase III global clinical trial investigating neoadjuvant immunotherapy for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
-
GA Screening: Early Detection For Future Trial Recruitment4/9/2026
Community-based screenings identify undiagnosed eye disease at high rates, creating a scalable, high-trust pathway for early intervention and improved clinical research recruitment.
-
Driving A High-Adherence LTFU Trial Without An EDC10/29/2025
Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.
-
Sensors And On-Demand eCOA7/13/2026
See how one rare disease trial eased caregiver burden by unifying glucose monitoring and patient diaries into a single app with real-time safety alerts.
-
Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder5/27/2026
Global approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.
-
ICON And Medable Drive 85% eConsent Adoption In U.S. Menopause Study4/1/2026
A site-focused strategy drove strong eConsent adoption in a complex women’s health study, showing how tailored training and hands-on support boost engagement and compliance.
NEWSLETTER ARCHIVE
- 10.22.26 -- From Psychedelics To Rare Disease: Navigating Regulatory Hurdles
- 10.22.26 -- [For Biotech] Build Smarter Oncology Trials
- 10.21.26 -- Choose Your Approach: Traditional, Hybrid Or Decentralized
- 10.21.26 -- From Protocol Design To Site Workflows: Building Trials That Run Smarter
- 10.20.26 -- Smarter Trial Tech: Vetting Medical LLMs, Rethinking eCOA, And Aligning eDiary Design
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.
-
![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.
-
![Mature student Studying-GettyImages-1460342076]( "Most Patients Learn About A Trial Online, But Is That What They Want?")
Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
FOCUS ON PATIENTS
-
![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.
-
![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?
