Newsletter | October 16, 2025

10.16.25 -- Import Product Specifications And Drug Registration Testing For China

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Smart Sourcing: Patient Recruitment & Retention Showcase, a virtual event for clinical teams to explore and compare top patient recruitment and engagement partners. Expect live 15-minute demos, side-by-side comparisons, real-time Q&A, and practical insights to boost enrollment, diversity, and retention. Ideal for Clinical Ops, Site Engagement, and Vendor Management teams. Leave with a vetted shortlist of partners and actionable takeaways—without the time, cost, or travel of traditional conferences.

REGULATORY & COMPLIANCE

Import Product Specifications And Drug Registration Testing For China

This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

The Central And Eastern Europe (CEE) Clinical Trials Report

This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.

The FDA's Remote Regulatory Assessments: The Future Of Inspections

Remote Regulatory Assessments (RRAs) provide distinct advantages over traditional inspections, such as increased efficiency, reduced travel costs, and enhanced global oversight capabilities.

Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook

This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

Expand Bandwidth With A Trusted Regulatory Writing Partner

Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

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ISPOR Europe 2025

As healthcare systems navigate increasing cost pressures, evolving regulatory landscapes, and rapid innovation, fostering deeper collaborations between patients, payers, providers, regulators, and industry is more critical than ever. Join global healthcare leaders, researchers, and decision makers at ISPOR Europe 2025 to explore how integrating and amplifying patient perspectives in value assessment, pricing, reimbursement, and market access strategies can lead to more equitable, sustainable, and impactful healthcare solutions.

OUTSOURCING MODELS

Should You Choose An FSP Model? It Depends…

Small biotechs are often drawn to an FSP model because they believe it’s a less expensive option as compared to an FSO. But that’s not always the case, says Réne Stephens of Danforth Advisors, who gives some examples of what to consider before making your choice of outsourcing solution.

8 Critical Questions To Ask Your IRB

This article outlines eight essential questions to ask a potential IRB partner to assess their ability to help you navigate complex regulatory requirements while avoiding delays.

Four Pivotal Categories To Elevate Your Clinical Vendor Management

For sponsors ready to improve vendor management, technology platforms with the right framework can help you tighten budget controls, improve data integrity, or foster collaborative vendor relationships.

Optimize CMC And Clinical Strategies For Injectable, Oral Peptide Drugs

Advances in peptide drug delivery have opened new opportunities for peptide drug products, with non-parenteral routes of administration — such as oral and nasal — now feasible.

Mitigating Risk And Complexity In Cell & Gene Therapy Trials With IRT

CGT pioneers require supply chain partnerships that mitigate trial risk and complexity. Explore how to optimize pre-trial and pre-screening activities and reduce trial cost and risk with an IRT solution.

Data Integrity Drives Every Step Of Your Clinical Trial

Choose the right Data Sciences team to save time without compromising quality. Find out what sets us apart, from comprehensive strategies to cutting-edge solutions.

The Team For Your Package Design Needs

Our dedicated team of in-house design specialists deliver insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

Commercial Drug Sourcing For Clinical Trials

Learn how the right partner can leverage years of experience, market knowledge, industry relationships, and clinical packaging expertise to develop a sourcing strategy tailored to the needs of each study.

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)

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