Helus Pharma CMO Amir Inamdar discusses the strategic rationale behind its Phase 3 trial for major depressive disorder, including its adjunctive-treatment approach, patient population selection, and endpoint strategy.
- AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them
- Will AI And Agile Project Management Help Advance RBM?
- The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future
- Why Building Long-Term Value And Making Clinical Progress Are Inextricable
- What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
- What Really Happens At The Site When Sponsors Pull Back Mid-Trial
- Where Are We With Clinical Trial Tokenization?
GUEST COLUMNISTS
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![Healthcare, public health, emergency care-GettyImages-2256438497]( "What Sponsors Don't See: The Systems Behind Clinical Trial Delivery")
What Sponsors Don't See: The Systems Behind Clinical Trial DeliveryWhat do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.
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![Negative results, anxiety, wrong procedure-GettyImages-2215185372]( "What Really Happens At The Site When Sponsors Pull Back Mid-Trial")
What Really Happens At The Site When Sponsors Pull Back Mid-TrialWhen sponsors slow or reduce operational spending due to financial pressure, strategic pivots, or internal restructuring, sites — and patients — suffer. Curo Research CCO Amy Bland explains how sponsors can better manage operational changes.
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![AI, digital innovation-GettyImages-2202490582]( "A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI")
A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROIClinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.
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![White spheres on curved lanes over blue wall-GettyImages-1390877978]( "One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution")
One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial ExecutionHaving the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.
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![Less Risk-GettyImages-1246366605]( "Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA")
Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDAFor nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.
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![Accountant using online spreadsheet-GettyImages-1652010771]( "The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help")
The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can HelpEveryday computational tools such as Excel are simple and easy to use, but they carry risk. Learn how these tools might not adhere to 21 CFR Part 11, and discover how AI can help keep them compliant.
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![Healthcare, disease-GettyImages-1284442724]( "To Prevent Parkinson's Disease, We Need New Biomarkers")
To Prevent Parkinson's Disease, We Need New BiomarkersParkinson's disease research has shifted toward prevention and prodromal intervention but success with disease-modifying and preventive therapies depends on validated PD-specific biomarkers. AC Immune Cofounder and CEO Andrea Pfeifer explains.
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![Cryptocurrency, Blockchain-GettyImages-1130554295]( "What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program")
What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration ProgramErnexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.
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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Empower Your Trial With Data And Evidence1/14/2026
Fuel your clinical development and decision-making with insights from fit-for-purpose data and evidence.
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Digital Endpoint Resource Guide: Parkinson's Disease8/20/2024
Explore how sensor-based digital health technologies can revolutionize the treatment and management of movement disorders by providing more accurate, patient-centered outcomes.
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Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape9/1/2025
Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
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Endpoint Clinical RTSM: Getting The Job Done12/5/2025
Explore how a Job-to-be-Done (JTBD)-focused RTSM approach reduces delays, optimizes costs, and accelerates trial success through predictive intelligence and streamlined global workflows.
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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating Approval Pathway For Phase III Ovarian Cancer Trial8/29/2025
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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Using eConsent Data To Populate Site And Sponsor Data Systems10/7/2024
A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.
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Delivering Complex Oncology Trials At Scale5/19/2026
Parexel delivered two complex, global Phase III prostate cancer trials by aligning site selection, logistics, imaging workflows, and RAM regulatory expertise—achieving faster enrollment and on‑time execution.
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Enhance DMC Services By Harnessing Biostatistics Expertise8/7/2024
Discover how expert biostatistics and project management ensured data integrity and efficient DMC operations in a complex clinical trial for hematologic cancer cell therapies.
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End-To-End Clinical, Biometrics, And Regulatory Support In Neurology6/4/2026
Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.
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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.
NEWSLETTER ARCHIVE
- 06.26.26 -- How Is Remote Monitoring Transforming Compliance?
- 06.26.26 -- Support For Clinical Trial Patients, From Payments To Home Trial Support
- 06.25.26 -- An Inside View Of The Clinical Trials Technology Congress
- 06.24.26 -- The Modern Trialist: Navigating Decentralized Models And Smart Management
- 06.24.26 -- STREAM Edition: Community Trust Can't Be Outsourced
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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![Crowd, Sale, road, promotion-GettyImages-1320971995]( "AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them")
AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
FOCUS ON PATIENTS
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![pre-filled GLP-1 receptor agonist pens-GettyImages-2225780922]( "The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future")
The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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![Blue Print-GettyImages-172211936]( "A Blueprint For Addressing Underserved Patient Populations")
Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
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![Disability, daily activities-GettyImages-2169336772]( "New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA")
NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.
