Newsletter | May 15, 2025

05.15.25 -- EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval

REGULATORY & COMPLIANCE

EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval

In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

Why Compassionate Use Should Not Replace Rigorous Clinical Trials

While compassionate use and expanded access programs provide lifesaving treatments outside clinical trials, the lack of structured protocols can lead to inconsistent data, compromising crucial evaluations.

Data Quality Framework For EU Medicines Regulation

Ensure compliance with the EU Data Quality Framework for medicines regulation by using this checklist or consulting with experts for personalized guidance to refine your data quality strategies.

Harnessing RWE For Effective External Control Arms In Clinical Trials

Real-world evidence (RWE) is transforming clinical trials by enabling the use of external control arms (ECAs), which serve as an alternative to traditional randomized control groups.

Strategies For Achieving Regulatory Milestones Faster

Explore how a vendor that offers integrated drug substance, drug product, and clinical testing activities under one organization facilitates improved communication and a more agile approach to development.

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.

OUTSOURCING MODELS

What The Heck Are Financial Accruals? A Guide To Understanding The Mysterious Finance Brain

Clinical finance consultant Chris Chan helps clinical professionals understand financial accruals concepts and interpret requests from finance colleagues.

How To Establish Effective, Scalable Drug Safety Ops Across Vendors

Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

Creating A Sustainable Pharmaceutical Supply Chain

Learn how CDMOs can drive transformation in the supply chain and create a more sustainable future for the pharmaceutical manufacturing industry.

First-In-Human Solution For Small And Large Molecules

Choosing the right CRO/CDMO for your first-in-human (FIH) trials enables you to run a successful study that generates high-quality data with speed and ease.

Clinical Trial Material Distribution Services

From assistance with time-consuming international documentation through destruction following all regulatory protocols, RPS is your trusted clinical trial partner.

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: