Learn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).
- My SCOPE Groundhog Day Experience
- How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)
- How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)
- These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials
- Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
- What ChatGPT Ads Will Really Mean For Clinical Trials
- The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?
GUEST COLUMNISTS
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The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?
Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.
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The Key Role Of Clinical Supply Teams In Patient Centricity Efforts
Clinical supply decisions shape patient access, safety, and trial success. From logistics to procurement, patient-centric supply can accelerate therapies or quietly delay them.
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Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure Innovation
To secure long-term innovation, Ascendis Pharma's Ivanna Rosendal suggests pharma companies should help startup companies through their growing pains.
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Becoming A Backbone Therapy: Lessons Learned With Actuate Therapeutics
CEO Dan Schmitt discusses the pursuit of a backbone therapy and how Actuate's current and planned trials are structured to confirm that potential.
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Building Patient Trust In Research Through Connection Driven-Transparency
The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
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How To Lead A Moonshot Collaboration: Lessons From Over A Decade Of Competitors Working Together
TransCelerate BioPharma's Andy Lee and Janice Change share the lessons they learned bringing disparate voices together for a united purpose.
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Patient Trust In Pharma Is Low; Here's How To Rebuild It
CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
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The U.S. Trial Advantage Is Eroding
Once the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.
CLINICAL TRIAL WHITE PAPERS
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The True ROI Of Decentralized Clinical Trials
Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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Eliminate Clinical Trial White Space With The Right AI Strategy10/9/2025
Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
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Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
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Retention Begins With Recruiting The Right-Fit Patients11/13/2025
Recruiting the right patients into a clinical trial is only half the battle. To combat attrition, sponsors must also institute measures that ensure patients remain comfortable and confident throughout the trial.
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Navigating The FDA's Drug Supply Chain Security Act3/14/2025
Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Duchenne Muscular Dystrophy Trial In China9/17/2025
A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.
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RTSM: Randomization And Cohort Management, IP Inventory Management4/17/2024
Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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Accelerating Early Phase Oncology Study Development4/17/2025
Explore a close collaboration to co-develop a comprehensive, adaptive protocol designed to support key decisions across multiple trial phases for an innovative cancer therapy.
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Breaking Barriers In ED Treatment: A 100% Recruitment Success!7/23/2024
Discover how Palleos achieved full patient enrollment across four countries in record time in an Erectile Dysfunction study.
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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Drug-Drug Interaction Study On A Novel Cardiovascular Medication9/17/2024
Learn how Altasciences leveraged its expertise to design, recruit, and conduct complex DDI studies, assessing pharmacokinetic and pharmacodynamic impacts of co-administered drugs.
NEWSLETTER ARCHIVE
- 02.14.26 -- Best Of January
- 02.13.26 -- Continuous Evidence Generation Remains Critical To Vaccine Development
- 02.13.26 -- Find A Consulting Partner To Boost Your Clinical Trials
- 02.12.26 -- What CROs Do Right Isn't Always Obvious To Research Sites
- 02.11.26 -- Clinical Supply's Role In Driving Success In Decentralized Trials
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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On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.
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AI health assistants may be used to surface clinical trials earlier in patient journeys, and advertising inside conversational AI is best understood as the next logical step in that same progression.
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The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
FOCUS ON PATIENTS
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Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
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Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.
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Clinical supply decisions shape patient access, safety, and trial success. From logistics to procurement, patient-centric supply can accelerate therapies or quietly delay them.