Newsletter | November 21, 2025

11.21.25 -- Continuous Evidence Generation Remains Critical To Vaccine Development

SPONSOR

Webinar: From Hesitation to Confidence: Should Sponsors Provide Source Document Templates to Sites? Let's Debate

Join CRIO for a thought-provoking webinar examining whether study sponsors should provide standardized, study-specific eSource templates to investigative sites. Explore both sponsor and site perspectives, uncover legal and regulatory nuances, and learn why opinions remain divided. Through structured debate and expert insights, gain practical clarity on this complex operational and compliance challenge in clinical research. Click here to learn more.

TRIAL MONITORING

5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution

Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

Huntington's Disease Clinical Trials: Innovation And Challenges

The Huntington’s disease (HD) landscape is undergoing rapid transformation driven by breakthroughs in gene-targeted therapies, small-molecule modulators, regenerative medicine, and digital innovation.

The Difference Between Clinical Trial Auditing And Monitoring

While both trial auditing and trial monitoring have the same goal of protecting participant safety and rights, they are two separate yet important pieces of the clinical trial process.

SPONSOR

Spotlight the Best in CRO Partnerships—Share Your Voice!

Help shape the future of CRO excellence! Take part in the 2025 CRO Leadership Awards Survey, conducted by Tufts CSDD and Clinical Leader. Your confidential feedback will determine the top CROs in project management, services, culture, and more. Winners will be celebrated through Clinical Leader events—don’t miss your chance to spotlight outstanding collaboration in our industry!

CLINICAL DATA MANAGEMENT & ANALYTICS

Continuous Evidence Generation — Including RWE — Remains Critical To Vaccine Development

President of Takeda's Global Vaccine Business Unit Derek Wallace discusses the importance of continuous, real-world data collection in the context of vaccine development in low- and middle-income countries.

AI As A Catalyst For Innovation In Healthcare: Part One

Explore the fascinating intersection of AI, software, and biology as Yochi Slonim shares his unconventional journey from debugging software to decoding disease at the cellular level.

Accelerate Review Times And Deliver Better Quality Documents

Diahann Homer and Kelly Spencer share strategies to streamline your document review process to boost quality, reduce cycles, and ensure compliance in medical writing.

Putting Trial Data Insights Into Action For Your Study

Learn why sponsors should implement an integrated data monitoring plan and technology solution to ensure data integrity, meet evolving regulatory requirements, and improve trial outcomes.

Optimizing Clinical Data: Reducing Redundancy For Efficiency

Enabling sites to focus solely on critical data facilitates faster data entry, reduces queries, and fosters better relationships between sponsors, CROs, and sites.

Accelerating Data Cleaning

AI-enabled clinical trial technology enables faster processing of large data volumes, thereby enhancing workflows, easing the burden on busy trial teams, and protecting patients.

Why Managing Direct Spend In NetSuite Leads To Commercial Success

Centralizing direct spend with the right tools enables you to manage critical inputs within the ERP and organizations to gain visibility for accurate demand planning and supplier performance tracking.

Here To Help You Succeed

IQVIA Biotech is a standalone business of IQVIA with dedicated teams delivering clinical development solutions for biotech and emerging biopharma customers.

Accelerate Clinical Insights: From Data Deluge To Decisions In Minutes

Unlock clinical trial insights in minutes, not months. Discover a platform that streamlines data review with AI-powered listings and visualizations to empower faster, smarter decisions.

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You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. 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)

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