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Latest News

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FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors

By Andy Studna, Senior Editor

July 25th 2025

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Empowering the Workforce of the Future: The Trends and Training That Will Drive the Future of Drug Development

By Keri Mattox

July 15th 2025

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment

By Christine Senn, PhD, FACRP

July 8th 2025

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.

Rewiring Clinical Research: AI-Augmented Data, Processes, and People

By Hilde Vanaken, PhD, Eng, MsC

June 26th 2025

AI as an accelerator for data-centric, process-centric, and human-centric clinical research.

Clinical Trials as a Competitive Edge: Strategic Considerations

By Mary Gunn, PhD, MBA

June 16th 2025

Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.

More News

Complex Trials, Clear Budgets: Global Clinical Trial Budgeting Strategies

IQVIA

April 15th 2024

Webinar Date/Time: Wednesday, May 22, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Automating document exchange can speed up reconciliation and study close-out. (Source: Veeva)

Focus on Fundamentals for Better Collaboration Across Research Sites and Sponsors

Kenny Kong

April 9th 2024

Improving the site-sponsor relationship can get trials off on the right foot and on a path for success.

Improve Study Outcomes Through Site-Centered eConsent Solutions

Maximize your Study’s Potential: How Expert Recommendations on Data Collection, Data Flow, Standards and AI can Transform Outcomes

IQVIA

April 5th 2024

Webinar Date/Time: Thursday, May 9th, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

The Evolution of FSP: Not Just for Large Pharma

IQVIA

April 4th 2024

Webinar Date/Time: Tuesday, May 7th, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

When FMVs Collide: Coming to Terms with Fair Market Value

Norman M. Goldfarb

January 19th 2024

With variation in costs between different stakeholders in clinical trials, there is often disagreement on fair market value.

Navigating the Complexities of Clinical Trial Budget Forecasting and Payments

IQVIA

January 2nd 2024

Top 3 Most Read CRO/Sponsor Feature Articles of 2023

Andy Studna, Senior Editor

December 29th 2023

Authors highlighted outsourcing and the impact of the COVID-19 pandemic in these CRO/sponsor articles from 2023.

Anticipating Near-Term Structural Change in the Outsourcing Landscape

Samir Shah

December 22nd 2023

Can full-service outsourcing to CROs by large biopharma companies sustainably prosecute a clinical development portfolio?

Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices

Medable

December 19th 2023

Webinar Date/Time: Wed, Jan 17, 2024 12:00 PM EST

Clinical Research Sites Have Spoken: How Can Sponsors and CROs Improve the Site Experience?

PAREXEL

November 21st 2023

Webinar Date/Time: Mon, Dec 4, 2023 11:00 AM EST

Harmonizing Outsourcing to Keep Clinical Trials on Track

Debbie Gilmore

November 17th 2023

A shared partnership culture is critical in navigating today’s complex terrain.

The Evolution of CRO and Sponsor Relationships

James Moat

November 16th 2023

Exploring the 11 key ‘warning signs’ that could impact partnership success.

The Two Guiding Principles of Optimal Trial Delivery

Rhonda Henry

November 15th 2023

Trust-based relationships form the foundation for successful trial management.

How to Achieve Comprehensive Oversight of Your Entire Portfolio of Clinical Trials

IQVIA

November 10th 2023

Webinar Date/Time: Tuesday, December 12th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET

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Creating Strategic Relationships: The Changing Face of Contract Research Organizations and Sponsor Partnerships

Jennifer Visser-Rogers

November 6th 2023

By taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.

Contract Research Organizations: Leveraging Technology for Success

Dave Espenshade

November 3rd 2023

The handling of payments is frequently an aspect of contract research organizations work that goes underappreciated and undervalued, despite its critical importance.

Reducing Trial Cycle Times: Highlighting the Importance of Efficient Forecasting and Team Building

IQVIA

October 31st 2023

Webinar Date/Time: Thursday, November 30th, 2023 at 3pm EST | 12pm PST | 8pm GMT | 9pm CET

Validation Considerations for AI-Enabled SaaS

IQVIA

October 27th 2023

Webinar Date/Time: Thursday, November 9th, 2023 Option 1: 9am EST | 6am PST | 2pm GMT | 3pm CET

Mastering the Logistics of Remote Visits in Global Decentralized Clinical Trials

PCM Trials

October 17th 2023

Webinar Date/Time: Tue, Nov 14, 2023 11:00 AM EST

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Outsourcing Model Usage and its Relationship to Clinical Trial Performance

Mary Jo Lamberti, PhD;Zachary Smith;Maria DiPietro;John Barry;Ken Getz, MBA

October 12th 2023

Pilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.