Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
- Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3)
- Caregivers: The Missing Line Item In Trial Budgets
- A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis
- Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
- Reminder: FDA Approval Is Not Synonymous With Commercial Success
- What Sites, Sponsors, Vendors, And CROs Can All Agree On
- AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
GUEST COLUMNISTS
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![reaching success after failure-GettyImages-2257935579]( "Reminder: FDA Approval Is Not Synonymous With Commercial Success")
Reminder: FDA Approval Is Not Synonymous With Commercial SuccessLife sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability.
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![life sciences future sw]( "What Sites, Sponsors, Vendors, And CROs Can All Agree On")
What Sites, Sponsors, Vendors, And CROs Can All Agree OnExperts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.
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![emerging legal frameworks, regulations governing artificial intelligence-GettyImages-2245648442]( "AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research")
AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical ResearchCompanies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.
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![modern medical research center, ct scan-GettyImages-2160715346]( "Is It Time To Replace RECIST — Or Just Add AI?")
Is It Time To Replace RECIST — Or Just Add AI?Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
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![India MAP-GettyImages-1195985043]( "India Opens The Fast Lane For Drug Development")
India Opens The Fast Lane For Drug DevelopmentNew in 2026, extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain.
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![Finance business trade economy-GettyImages-2230458034]( "U.S. Pharma Tariffs And MFN Become Law After April 2 Update")
U.S. Pharma Tariffs And MFN Become Law After April 2 UpdateBeginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
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![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem ListensPatient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
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![Young female scientist works at work bench in laboratory-GettyImages-899074182]( "What Really Moves The Needle In Primary Immunodeficiency Research And Treatment")
What Really Moves The Needle In Primary Immunodeficiency Research And TreatmentKedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1068004492 women]( "Decentralized And Community-Based Solutions Driving Women's Healthcare")
Decentralized And Community-Based Solutions Driving Women's HealthcareClinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More3/25/2026
High-end technology cannot fix poor rater preparation or complex patient needs. True data integrity requires bridging the gap between digital platforms and the reality of clinical implementation.
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4 New Approvals In Q3 Across Gene, Cell, RNA Therapies11/13/2025
Q3 2025 brought notable progress across the gene, cell, and RNA therapy landscape, marked by four new global approvals. While regulatory progress continued, clinical development activity slowed.
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Strategies For Post-Approval Lifecycle Management And Local PV7/12/2024
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
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Pharma R&D Review 2024: Pleasant Weather Ahead5/16/2024
Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.
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AI in Pharma: Benefits, Risks, And The Road Ahead10/23/2024
How could leveraging AI technologies, including machine learning (ML) and generative AI (GenAI), enable your company to streamline processes from drug discovery to post-launch?
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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Rescuing Data Integrity: A Swift Transition And Quality Transformation11/14/2025
Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
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Overcoming Participant Compliance Challenges In A Medical Device Study9/9/2024
Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.
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Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling3/12/2026
See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.
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From Months To Hours: MMC Medical's EDC Revolution3/31/2026
Learn how a specialized CRO reduced study build times by 95%. Discover strategies for template reusability and flexible resource scaling to accelerate early-stage medical device validation.
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Unlocking Recruitment Potential In Trial-Naïve Sites4/17/2025
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
NEWSLETTER ARCHIVE
- 04.23.26 -- Oncology Insights For Sponsors Navigating Complex Development
- 04.22.26 -- Accessibility For Pediatric Patients
- 04.22.26 -- STREAM Edition: Quantifying The Impact Of AI-Enabled Trial Delivery
- 04.22.26 -- [Biotech Innovators] Level Up Your Oncology Trials
- 04.21.26 -- Think Big, Start Small With AI
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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![Contract, signing and signature, life insurance-GettyImages-1796424011]( "Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials")
Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
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![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
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![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
FOCUS ON PATIENTS
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![Contract, signing and signature, life insurance-GettyImages-1796424011]( "Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials")
Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
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![Rheumatism symptom, knee pain-GettyImages-2182419049]( "The Patient-Centered Trial Paradigm For Knee Osteoarthritis")
Although PROs can complicate a trial design, they're essential to reflecting a patient’s true knee OA experience and producing meaningful evidence, explains Katie Mowry, Ph.D., VP of R&D at Organogensis.
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![Nurse, patient, and daughter talking about prescription medication in a hospital-GettyImages-2210890101]( "Caregivers: The Missing Line Item In Trial Budgets")
More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.
