The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
- What Really Happens At The Site When Sponsors Pull Back Mid-Trial
- Where Are We With Clinical Trial Tokenization?
- 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
GUEST COLUMNISTS
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
CLINICAL TRIAL WHITE PAPERS
-
![GettyImages-1025834378-manufacturing-excipient-drug-pharma]( "Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers")
Navigating Adverse Immunostimulation: A Practical Guide For Clinical ResearchersExplore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.
-
Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
-
Real-Time Clinical Data Insights Delivered By Automation And AI2/26/2026
Automated data flows and human‑guided AI enable faster, more reliable oversight into clinical trials. Learn how real‑time insights and unified monitoring support quality, efficiency, and readiness.
-
A Guide To Patient Reimbursements And Payments9/13/2024
Delayed or inadequate payments can harm patient retention and site efficiency. Learn how sponsors can mitigate financial toxicity, streamline reimbursement, and ensure a positive experience for all involved.
-
Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?10/20/2025
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.
-
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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence3/10/2025
A top-10 global pharma company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites in Japan. Explore an initiative to enhance the patient and site experience.
-
Case Management Accelerates Shipment For SCN1A+ Dravet Syndrome Gene Therapy3/12/2026
Consider this streamlined, end-to-end solution that helped safeguard study timelines and ensured that patients with urgent medical needs could receive treatment without delay.
-
Automated Trial Monitoring Workflows Make A Lean Team More Efficient1/7/2026
A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
-
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.
-
Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
-
Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
NEWSLETTER ARCHIVE
- 06.23.26 -- Connected Trials: From AI Strategy To Patient Adherence
- 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
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.
-
![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.
-
![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.
-
![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
-
![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.
-
![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.
