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
-
Radiation Therapy Quality Assurance In Clinical Trials
Here, the authors describe the crucial role of radiation therapy in oncology trials and how a robust quality management program can enhance treatment outcomes and research efficacy.
-
Digital Biomarker Upholds Adherence, User Satisfaction, Validity3/25/2024
Digital biomarkers, smartphones, and wearables are transforming clinical trials by enabling remote data collection and offering insights into treatment efficacy. Discover how these exploratory endpoints enhance confidence in clinical trials.
-
Patient-Reported Outcome In Oncology Clinical Trials4/17/2025
As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care.
-
Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
-
Streamlining Clinical Trial Start-Up In Australia10/20/2025
Gain a comprehensive overview of how sponsors can accelerate clinical trial start-up in Australia, leveraging the nation’s unique strengths as a global hub for clinical research.
-
The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality11/18/2024
Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Paperless Online Remote Source Document Verification2/2/2026
Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
-
Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
-
How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
-
CRO Uses CRIO eSource To Double Monitoring Productivity1/31/2025
Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.
-
Boosting Recruitment Strategy For Phase III Study In Ulcerative Colitis6/10/2025
Learn about the successful execution of a challenging three-arm, randomized, placebo-controlled Phase 3 study in Ulcerative Colitis despite strict inclusion criteria and a limited patient pool.
-
How To Seamlessly Integrate NetSuite With Power BI8/12/2024
Unlock the power of your NetSuite data with seamless integration to Power BI. Learn how to automate data refresh, gain real-time insights, and make informed business decisions.
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.