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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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
-
Empower Your Trial With Data And Evidence
Fuel your clinical development and decision-making with insights from fit-for-purpose data and evidence.
-
The Rapid Digitization Of Trials11/7/2024
It’s no secret that more trials are going digital. Hear from a panel of industry experts including Sanofi, Bayer, and the Clinical Trials Transformation Initiative (CTTI) as they discuss the evolution of digital trials and share their experiences.
-
Elevating Patient Centricity In Clinical Trials2/17/2025
How can the integration of patient perspectives throughout the clinical trial process enhance engagement and outcomes?
-
Planning For High-Performance Hematologic Oncology Clinical Trials5/7/2024
Running successful clinical trials in hematologic malignancies necessitates a deep comprehension of a swiftly evolving treatment framework that is growing more nuanced, intricate, and patient-centered.
-
Automated Evidence Generation For Regulatory-Grade RWD10/20/2025
Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.
-
A New, AI-Augmented Horizon For Safety And Pharmacovigilance1/6/2026
Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Recruiting & Retaining More Patients Per Site:3/14/2025
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
-
Our Unified Platform Serves As eSource For COVID Treatment Trial6/17/2024
Signant Biotech optimized technology for an emerging biopharmaceutical's Phase 2 COVID treatment trial in critically ill patients, minimizing paper data risks and streamlining consent and data management across multiple sites and solutions.
-
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.
-
Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform addresses prevalent pain points faced by trial coordinators by streamlining workflows, automating patient communication, and providing intuitive dashboards that simplify trial management.
-
Meeting 100% Recruitment 7 Months Ahead Of Schedule7/23/2024
Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.
-
Removing Translation Bottlenecks With AI8/8/2025
See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.
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.
-
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.
-
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.
-
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
-
Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
-
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.
-
Clinical supply decisions shape patient access, safety, and trial success. From logistics to procurement, patient-centric supply can accelerate therapies or quietly delay them.