Principal 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.
- New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA
- The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?
- How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly
- 3 Views From Inside FDA's RTCT Pilot
- 5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift
- Lessons In Pivoting From A Clinical Trial Launch In Uganda
- DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD
GUEST COLUMNISTS
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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
Lessons In Pivoting From A Clinical Trial Launch In UgandaGates 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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![Gastroenterology analysis, diagnosis, screening, medical research analytics-GettyImages-2261860563]( "DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD")
DDW 2026 Signalled The Next Era Of Competitive Landscape In IBDAt the DDW 2026 meeting, the IBD landscape was portrayed as increasingly competitive and diversified, with emerging players and novel mechanisms challenging established standards of care.
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![Computer programmer at desk-GettyImages-973716000]( "What Is Computer Software Assurance, And What Are Its Benefits?")
What Is Computer Software Assurance, And What Are Its Benefits?Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.
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![GettyImages-1447898051]( "The FDA Is Rudderless And Clinical Trials Are Left Adrift")
The FDA Is Rudderless And Clinical Trials Are Left AdriftFormer commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
Expanding Access To Cell Therapy Trials Beyond AMCs And Into The CommunityCEO 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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![ispor]( "What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026")
What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.
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![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "Why Tolerability Will Drive The Next Wave Of Obesity Treatments")
Why Tolerability Will Drive The Next Wave Of Obesity TreatmentsFor the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
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![Genetic engineering, GMO and Gene manipulation-GettyImages-1344879684]( "Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge")
CLINICAL TRIAL WHITE PAPERS
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![route path, future transport logistics,GettyImages-1673636482]( "Modernizing Clinical Trial Logistics To Deliver Value")
Modernizing Clinical Trial Logistics To Deliver ValueExplore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
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Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials11/21/2025
This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies.
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Best Practices In Rare Disease Patient Recruitment3/9/2026
Recruiting for rare disease clinical trials is daunting, and making patients aware of clinical trials, involving them in trial design, and building trust are a few ways sponsors can boost recruitment.
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Proving The Return On Investment For eRegulatory1/22/2025
Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.
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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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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Cracking The Code: Strategies For Success In Complex Trials8/27/2024
Navigating the complexities of modern clinical trials requires advanced technology and strategic planning. Learn what goes into managing a challenging, decentralized rare disease trial.
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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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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.
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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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GSK And Medable Discuss The Next Phase Of DCTs3/10/2025
GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
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Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission1/27/2026
Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
NEWSLETTER ARCHIVE
- 06.11.26 -- Why Contracts Need To Catch Up To AI Appears In Clinical Trials
- 06.10.26 -- AI Amplifying Capabilities And Risks: The Legal Consequences Of AI In Clinical Research
- 06.10.26 -- STREAM Edition: Is Real-World Data "Messy?"
- 06.09.26 -- Navigating Risk And Capital Scarcity With AI
- 06.08.26 -- Personal And Financial Support For Clinical Trial Participants
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.
-
![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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![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.
-
![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "Why Tolerability Will Drive The Next Wave Of Obesity Treatments")
For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
