When 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.
- 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
- A Blueprint For Addressing Underserved Patient Populations
GUEST COLUMNISTS
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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.
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![Healthcare, cooperation, teamwork-GettyImages-2191354117]( "How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly")
How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running SmoothlyWhen acquiring another company, the acquiring sponsor must preserve operational continuity across active trials while integrating new assets, teams, technologies, vendors, and decision structures. Leila Cupersmith explains how.
CLINICAL TRIAL WHITE PAPERS
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![GeyyImages-1133420240 payments]( "Navigating The Complexities Of Clinical Trial Site Payments Forecasting")
Navigating The Complexities Of Clinical Trial Site Payments ForecastingAdvanced technology and best practices have the potential to revolutionize clinical trial site payment forecasting, leading to significant improvements in overall trial efficiency and management.
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Demonstrating IDS Value With Time-Based Metrics6/10/2026
Explore how leading IDS pharmacies are using remote monitoring workflows and digital accountability systems to improve accuracy, reduce site burden, and maintain audit readiness.
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Disclosure Management System: Build Or Buy?6/19/2025
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
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10 Clinical Research Practices That Feel Like Compliance (But Aren't)3/24/2026
Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
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Navigating The Challenges Of Large, International Phase III Breast Cancer Trials5/27/2026
In the competitive landscape of breast cancer research, aligning biomarker testing, regulatory pathways, and regional operations from day one creates a path to faster enrollment and stronger outcomes.
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How Adaptive Design Accelerates Early‑Phase NSCLC Development5/22/2026
Adaptive trial designs and an adaptive mindset enable non-small cell lung cancer (NSCLC) sponsors to optimize dose, respond to evolving expectations, and accelerate early‑phase development.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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What Unified eCOA And IRT Can Unlock4/6/2026
See how real-time scoring and automated eligibility checks helped a global dermatology study reduce site burden, avoid manual errors, and move participants through screening with greater speed.
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A Community-Focused Approach To Metabolic Disease Trials8/28/2024
Learn how innovative strategies like free health exams, community engagement, and a comprehensive patient database helped this project achieve rapid enrollment with a high level of patient diversity.
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Transforming European Case Intake Operations5/26/2026
Centralized intake and semi‑automation brought clarity and control to European safety reporting, improving oversight, data quality, and compliance across multiple partners and countries.
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Paperless Online Remote Source Document Verification2/2/2026
Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
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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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Quantitative ROI With DCTs11/13/2025
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
NEWSLETTER ARCHIVE
- 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
- 06.17.26 -- STREAM Edition: From Patient Recruitment To Audit Readiness: Improving Trial Outcomes
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.
-
![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.
