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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![GettyImages-1268717577-doctor-meeting-with-business-professional-computer-office]( "Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?")
Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
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Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
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The EMR Interoperability Dream Vs. Clinical Research Reality10/20/2025
Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.
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AI-Driven Signal Management: The Future Of Drug Safety12/19/2025
By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.
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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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Futureproofing Post-Approval Compliance4/15/2026
In the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Biotech Startup Transformed Their Clinical Trial Supply Management2/25/2026
Don’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
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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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Optimizing EDC Strategy And Data Collection for a Rare Disease Trial6/11/2025
Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
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Leading Recruitment With A Strong Alzheimer's Referral Pool2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
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Post-Market Safety And Risk Management in DMD4/11/2025
The pharmaceutical company specializing in rare neurological diseases sought solutions after encountering significant hurdles in post-market safety surveillance.
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Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
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.
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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.
