Newsletter | December 16, 2025
TOP 10 FROM THE EDITOR
1.
Why CRO Site Network Strategies Confuse Me
2.
Why More Biotechs Are Starting Trials In Australia
3.
Clinical Trials At A Crossroads
4.
The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call
5.
The Evolution Of A Clinical Research Coordinator
6.
Inside A Micro-CRO's Evolution
7.
Gottlieb Warns Leaner FDA Will Challenge ClinOps
8.
My Unexpected Takeaways From The SCRS Conference
9.
DCT Benefits Are Proven, Yet Progress Is Slow
10.
When Survival Comes First, Trials Come Last
TOP 10 GUEST COLUMNS
GCP Oversight Simplified: A Quick Guide
By Daniele Novara
RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It?
By Smit Patel, PharmD, director of partnerships, Digital Medicine Society (DiMe)
FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings
By Pradeepta Mishra, VP, AI Innovation, Beghou Consulting
RWE Is Not Optional, It's Essential
A conversation with Jennifer Timoshanko, head of medical strategy, bone health, UCB.
How AI Can Accelerate Clinical Trials' Probabilities Of Technical And Regulatory Success (PTRS)
By Kelly H. Zou, Ph.D., PStat®, FASA, CEO, AI4Purpose Inc. and president, American Statistical Association NYC Metropolitan Area Chapter
How AI Is Rewriting The Future Of TMF And Clinical Quality
By Donatella Ballerini, GCP and AI consultant
4 Clear Trends In Outsourced Clinical Services
By Matt Wheeler, Ian Tzeng, Kevin Giffels, and Jason Dorr, L.E.K. Consulting
RWD Helps Abbvie Bridge Oncology Trial Data Gaps
A conversation with Svetlana Kobina, MD, Ph.D., vice president of global and U.S. medical affairs oncology, AbbVie
Mastering The Monitoring Visit: Key Tips For Site Success
By Rachana Kanvinde, MS, SFC, CCRP
All Of Us Need To Be Rooting For The FDA
By Steven Grossman, FDA Matters
TOP 10 INDUSTRY INSIGHTS
Do CROs Need To Reinvent Themselves In 2025?
By Castor
The Power Of AI To Improve Clinical Trial Monitoring
By Nicola Phillips and Tameka Johnson, inSeption Group
The Role Of AI Throughout The Clinical Research Journey
By Crucial Data Solutions
Key Update On Guideline For Good Clinical Practice E6(R3)
By Elizabeth Bodi, Halloran Consulting
The Regulatory Binder Checklist For Clinical Trial Sites
By Meghan Hosely, Advarra
What Does 2025 Hold For Pharma?
By Darcy Grabenstein, Citeline
eTMFs Uncovered: 5 Costly Misconceptions To Avoid
By Florence Healthcare
Understanding The FDA's Push For More Representation In Clinical Trials
By Miranda McLaren, EmVenio Clinical Research
Five Predictions For Clinical Research In 2025
By Mo Punjwani, Mural Health
Accelerating Site Activation: Examples From Novartis And IQVIA
By Rosemary Shirey, IQVIA Technologies
TOP 10 SOLUTIONS
Auto Generate Documentation
IQVIA Technologies
Clinical Trial Regulations
CHDR
Leveraging Mobile Research Nurses For Clinical Trial Success In Vulnerable Patient Populations
EmVenio Clinical Research
Revolutionizing Clinical Trials: The Power Of Site-First Technology
Florence Healthcare
Clinical Operations: From Study Feasibility And Recruitment To Trial Monitoring And Quality Assurance
Southern Star Research
Central IRB Services
BRANY
The PPD Clinical Trial Forecasting Suite
PPD Clinical Research Business of Thermo Fisher Scientific
Introduction To An End-To-End Clinical Data Science Platform
Revvity Signals Software, Inc.
10 Reasons To Use Mobile Research Nurses In Your Next Study
Clinical Trial Recruitment Reinvented
CSSi - An Elixia Company
