Newsletter | April 10, 2025

04.10.25 -- Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K.

OUTSOURCING MODELS

Multiple Partnerships Help Drive Precision Medicine Trial For Parkinson's

Neuron23 CMO Sam Jackson, MD, explains the company’s desire to set a new standard in precision medicine for neurology, backed by well-aligned partnerships and fit-for-purpose digital biomarker solutions. 

Demystifying CGT Studies In Australia And The Broader APAC Region

Though conducting your clinical trial in Australia may initially seem daunting, the benefits are ample. Australia is home to qualified CRO partners that will guide your CGT to regulatory success.

Reducing Time To First-In-Human Trials With Robotic SFF Services

Discover how robotic gloveless isolator sterile fill-finish (SFF) systems can accelerate early-phase drug development, ensuring enhanced sterility and streamlined processes for biopharma innovation.

Accelerated Peptide Drug Development And Clinical Strategies

Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

Bioanalysis Solutions

Learn how a bioanalytical testing partner with comprehensive solutions and unwavering commitment to quality can help you bring safe and effective drugs to market with confidence.

Get To Know Citeline Clinical Solutions

To maximize drug development investments, it’s important to find a provider with solutions to optimize and accelerate the entire development timeline, from pipeline to market.

Your Oncology CRO Dilemma Solved

Palleos Oncology is a comprehensive solution designed to support pharmaceutical companies throughout the entire lifecycle of oncology treatment development.

REGULATORY & COMPLIANCE

Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K.

Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.

Beginner's Guide To Human Research Protection Programs

Unearth several of the essential elements that constitute a successful HRPP to better protect the rights, safety, and welfare of research participants.

The Future Of Good Clinical Practice: The ICH E6(R3) Update

The release of the ICH E6(R3) Good Clinical Practice guideline in January 2025 marks a shift in clinical research, with significant implications for CROs, trial design, and quality management. 

A Strategic Approach To CAGT Study Conduct And Operations

Cell and gene therapy clinical trials require adaptive regulatory and operational strategies to address complex challenges, streamline patient engagement, and support successful development and delivery.

Global Regulatory Excellence During The Clinical Development Lifecycle

Navigating the intricate global regulatory path is crucial for clinical development success. See how expert-backed support has consistently propelled sponsors toward regulatory excellence.

IQVIA Regulatory Affairs And Drug Development Solutions

Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services helps to reduce time, cost, and risk, from discovery through post-registration.

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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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