Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
- When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
- FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now
- SCOPE Takeaways On Inclusion And Real Patient-Centricity
- 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
GUEST COLUMNISTS
-
These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials
Minovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.
-
Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
-
What ChatGPT Ads Will Really Mean For Clinical Trials
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 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.
CLINICAL TRIAL WHITE PAPERS
-
Navigating The European Market's Regulatory Complexities
Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.
-
Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
-
The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting10/30/2024
The twin pressures of inflation and attrition prolong negotiations between sponsors and clinical sites, stalling drug development. Sponsors need up-to-date, reliable benchmark data to negotiate fair market value budgets.
-
Accelerate Drug Development With Master Protocols5/15/2025
Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
-
The Hidden Problem In Early Phase Oncology Trials9/23/2025
Integrating patient-reported outcome measures (PROMs) can enable improved capture tolerability and optimize dosing decisions.
-
Site Perspectives On BYOD ePRO Use6/17/2024
This study examines participant convenience and compliance, aiming to understand and address the challenges faced by site personnel in global trials.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Data Matters: Accelerating Dermatology Research With Precision!7/23/2024
When deadlines are tight, execution matters. Find out how Palleos delivered critical data packages, statistical analysis, and regulatory-ready documentation—on time and with precision!
-
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.
-
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.
-
Guiding GLP-1 Participants Through The Challenge Of Retention12/4/2025
Learn how remote lifestyle coaching can combat high dropout rates in metabolic research by offering the support participants need to maintain adherence and ensure data integrity.
-
Digital Biomarkers Show Pathway To Reduced Study Sample Sizes, Shorter Durations7/8/2024
Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.
-
Streamlining Study Start-Up For Accelerated Drug Development2/20/2024
What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.
NEWSLETTER ARCHIVE
- 02.18.26 -- Making Medical Innovation Matter To Patients With Simplified Trial Design
- 02.18.26 -- STREAM Edition: Empower Efficient Clinical Study Execution
- 02.17.26 -- Digital Protocols Are At An Inflection Point
- 02.16.26 -- Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
- 02.14.26 -- Best Of January
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.
-
Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
-
Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.
-
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.
FOCUS ON PATIENTS
-
Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
-
Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.
-
Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.