Newsletter | July 3, 2025

07.03.25 -- Navigate FDA Regulatory Changes

OUTSOURCING MODELS

It's Time To Change How We Engage Research Sites

Site operations expert Maria Ladd argues for a major change in how sponsors and CROs communicate and work with clinical research sites.

The Rescue Option: Course Correcting Struggling Clinical Trials

The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

Executive Q&A With SGS' Hudson, NH Bioanalytical Services Facility

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Reimagining How You Bring Life-Changing Therapies To Patients

Accelerate your therapy's path to market and create better experiences with the right partner to provide end-to-end Clinical Development expertise.

Your Global CRO Partner In Ophthalmology

Ophthalmic drug and device development demands precision, agility, and deep therapeutic knowledge. Discover how our focused ophthalmology expertise can support your next clinical breakthrough.

How Sponsors Can Leverage New Technologies To Lower Trial Costs

This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.

REGULATORY & COMPLIANCE

Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

The Benefits Of U.S. Biotechs Conducting Clinical Trials In Australia

As U.S. biotech investment continues to rise, cross-border collaboration and trial design innovations are expected to further solidify Australia’s role in the early-stage biotech development pipeline.

Ensuring Compliance When Using Wearables In Clinical Trials

As wearable technology takes on a central role in clinical research, explore how its benefits can be maximized while navigating the increasing complexity of regulatory compliance.

A Roadmap To Expedited Review Pathways

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

Driving Safety And Compliance Seamlessly

Whether it’s accelerating market entry with the “FSP Country in a Box” solution or maintaining global compliance through expert oversight, IQVIA empowers organizations with scalable, localized support.

SURVEY

Have you outsourced in clinical trials?

Tell Clinical Leader how we can better support you in finding the right partners. 

 

Share your thoughts here.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

Learn more about our personalized newsletters here.

Connect With Clinical Leader: