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.
- 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
- Is It Time To Replace RECIST — Or Just Add AI?
- India Opens The Fast Lane For Drug Development
GUEST COLUMNISTS
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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.
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![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access SuccesseGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
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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)")
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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1474595785 AI]( "Demanding More From AI Governance In Drug Safety")
Demanding More From AI Governance In Drug SafetyEmbedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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Considerations For Plain Language Summaries4/22/2024
Recent FDA emphasis on plain language underscores a shift towards greater transparency and patient understanding, highlighted in the joint FDA and Office for Human Research Protections (OHRP) draft guidance.
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Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation10/23/2025
A consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.
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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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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning1/31/2025
The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
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How A Rare Disease Biotech Replaced Manual Processes With RTSM Software3/26/2026
Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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Streamlining Phase 1 Trials With The Mobile Vision Pod1/29/2025
A contract research organization formed a partnership to address significant challenges during a Phase 1 clinical trial for a corneal disease treatment through the use of a Mobile Vision Pod.
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How Syneos Health Tackles Protocol Complexities1/7/2025
Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase I-IV clinical trials, particularly under a complex adaptive trial protocol.
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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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Reinventing Prostate Cancer Diagnostics With An All-In-One Platform3/31/2026
Discover how a lean research team saved an estimated $100k and reached 95% data compliance by unifying their clinical workflow.
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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![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.
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![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
FOCUS ON PATIENTS
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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.
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![Insulin pen, medical equipment-GettyImages-1447329677]( "Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center")
For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
