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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Disclosure Management System: Build Or Buy?
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
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Pharma R&D Review 2024: Pleasant Weather Ahead5/16/2024
Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.
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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.
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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.
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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.
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A Strategic Guide For Biotech And Biopharma Leaders5/15/2025
Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
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Unlocking Recruitment Potential In Trial-Naïve Sites4/17/2025
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
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Quantitative ROI With DCTs11/13/2025
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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GxP Inventory Solution Delivers Real-Time Visibility, Operational Efficiency12/10/2025
Explore how unified forecasting and GxP-level inventory control can streamline your clinical supply chain, reduce risk, and strengthen oversight across every trial you run.
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.