Cereno 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.
- 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
- The Patient Recruitment Debate Nobody's Having
GUEST COLUMNISTS
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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")
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![Female doctor examining patient-GettyImages-2217109316]( "Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors")
Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid TumorsKivu Bioscience CEO Mohit Trikha, Ph.D., contends that safer ADCs enable higher effective dosing and could elicit a better response in solid tumors. In this Q&A, he also discusses how parallel trial execution, global site strategy, and stakeholder collaboration support rapid, data-driven development.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1309471798 respiratory]( "A Guide to Digital Endpoints in Respiratory Diseases")
A Guide to Digital Endpoints in Respiratory DiseasesLearn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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Go From Three Meetings To One With AI-Enabled eCOA5/5/2026
Learn how to turn three meetings into one with AI that is streamlining clinical workflows by reducing redundant steps, simplifying site operations, and accelerating data collection.
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Biopharma Reaping Numerous Benefits From AI2/18/2026
Multiple AI use cases with significant impact have been identified, and they are expected to drive innovations in clinical trials, precision medicine, and commercial operations.
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Transforming Effective Patient Recruitment Within The Changing Health Care Landscape2/6/2026
Revolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.
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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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Challenges And New Approaches To Developing Clinical Evidence For Medical Devices9/12/2024
Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication1/29/2025
This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
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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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Phase 1 Trial In Painful Diabetic Peripheral Neuropathy2/24/2026
A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
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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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Participant Support In Oncology Trials With Cachexia-Related Burden4/21/2026
Coordinated travel, reimbursements, and visit logistics for oncology participants experiencing fatigue, weight loss, and reduced mobility, helping reduce dropouts and keep people engaged.
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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.
NEWSLETTER ARCHIVE
- 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
- 06.05.26 -- FDA's Draft Guidance On Bayesian Methods
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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![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.
