What 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.
- A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI
- One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution
- Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA
- The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help
- To Prevent Parkinson's Disease, We Need New Biomarkers
- What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program
- What ClinOps Gets Wrong About Pediatric Trials
GUEST COLUMNISTS
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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.
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![Blue Print-GettyImages-172211936]( "A Blueprint For Addressing Underserved Patient Populations")
A Blueprint For Addressing Underserved Patient PopulationsDoes 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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![AI, artificial intelligence-GettyImages-2224574999]( "Why Clinical Data Standards Matter In An AI-Driven World")
Why Clinical Data Standards Matter In An AI-Driven WorldNovartis technology and scientific computing expert Bill Illis discusses what changes sponsors must make to the R&D data landscape to achieve sustained, meaningful progress — with the help of AI — to bring new therapies to patients faster.
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![Technology innovationj-GettyImages-1007108002]( "How The Quiet Data Standards Revolution Is Impacting Drug Approval")
How The Quiet Data Standards Revolution Is Impacting Drug ApprovalPrincipal Statistical Programmer Varun Debbeti details the role data standards play in approval timelines, detailing shortfalls of current the model and CORE, Dataset-JSON, and SDTM v3.0 stand to make an impact.
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![Human Circulatory System Heart Anatomy-GettyImages-2202279387]( "Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension")
Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial HypertensionCereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.
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![business people working together-GettyImages-500224928]( "What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use")
What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And UseBenchmarking is widely used and highly valued, yet trust in it is limited. The League Benchmarking Working Group has set out to standardize how site metrics are defined, contextualized, and applied.
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![Disability, daily activities-GettyImages-2169336772]( "New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA")
New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDANervGen 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.
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![Bacterial cells chains, Streptococcus pyogenes-GettyImages-2161636013]( "The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?")
The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?Strep A kills around 500,000 people each year, and a vaccine would change this and is within reach. Yet, no strep A vaccine is currently in Phase 3. 1Day Sooner's Josh Morrison explains why and shares how FDA could make Strep A vaccines a reality.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1397344064 Alzheimers]( "Addressing Trial Design Hurdles Across Alzheimer’s Disease Stages")
Addressing Trial Design Hurdles Across Alzheimer’s Disease StagesExplore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
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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.
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Looking Beyond Weight Loss In The Obesity Pandemic: What's Next?7/12/2024
Here, we analyze the current landscape of obesity management, underscoring the critical need for comprehensive approaches that prioritize overall well-being beyond simple weight reduction.
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Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
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Demanding More From AI Governance In Drug Safety8/13/2025
Embedding 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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Meeting The FDA's New Real-World Evidence Standards5/27/2026
FDA guidance is reshaping RWE strategy. Sponsors that build interoperable, audit-ready RWD infrastructure now will be best positioned for faster, defensible submissions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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A Mission To Expand Recruitment Territory6/11/2026
Learn how a proactive feasibility approach helps sponsors strengthen enrollment forecasting, mitigate risk, and implement timely interventions that improve study execution and clinical development.
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Data Key In Addressing Patient Recruitment Challenges6/19/2025
Explore how a Phase II trial for extensive-stage and previously treated small cell lung cancer overcame recruitment challenges with a data-driven solution designed to surface protocol-matched patients.
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Changing The Clinical Feasibility Game With AI1/22/2026
AI is only as good as the data it’s built upon. Our customized AI platforms are constructed on a foundation of trustworthy, carefully curated data to produce detailed, expert-driven responses.
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Helping To Power The WHO Solidarity Trial Against COVID-193/21/2025
To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.
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Powering Complex Personalized Medicine Oncology Trial2/25/2026
Managing custom therapies requires a synchronized supply chain. Learn how to bridge the gap between manufacturing and clinical workflows to ensure seamless patient care in complex oncology trials.
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Optimizing Wearable Adherence In A Phase 3 Oncology Trial5/15/2026
Long-term wearable monitoring only works if patients keep wearing the device, and in oncology trials, that’s easier said than done.
NEWSLETTER ARCHIVE
- 06.22.26 -- Rethinking Reach: From Underserved Populations To Better Recruitment
- 06.19.26 -- AI-Driven Clinical Trial Innovation: From Recruitment To Execution
- 06.19.26 -- Lab, Site, And Travel Services To Satisfy Your Patients
- 06.18.26 -- From Scorecards To Strategy: Advancing Clinical Trial Partnerships
- 06.17.26 -- Reducing Complexity Across The Clinical Trial Lifecycle
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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![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.
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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
FOCUS ON PATIENTS
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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.
-
![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.
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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.
