Newsletter | November 21, 2024

11.21.24 -- The Benefits Of The New ICH M11 Guideline

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REGULATORY & COMPLIANCE

The Benefits Of The New ICH M11 Guideline

With 25 years of global data science experience, Jessica Jolly gives a quick overview of the ICH M11 guideline and talks about some specifics of its two pillars: standardization and automation.

PV Solutions Optimizing End-To-End Safety In Clinical Development

Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.

Navigating The Regulatory Maze Of Targeted Medicines

Learn more about the importance of early engagement with regulatory agencies and collaborating with experienced authorities to streamline the review process and enhance market access.

GxP Audits Guide For Successful Clinical Trials

This step-by-step guide helps sponsors and sites prepare for and navigate the various types of audits required at each stage of the clinical trial process.

A Clearer Harmony And Attractiveness For EU Clinical Trials Regulation

Explore the latest insights on navigating the transition to the EU Clinical Trials Regulation (EU CTR) and ensuring alignment across stakeholders for seamless adaptation in this Pharmaphorum podcast.

Cardiovascular Clinical Development

Worldwide offers a full suite of services and a team of experts to support your cardiovascular therapy development and ensure your program's success throughout all clinical phases.

Maintain Control Over Your Regulatory Path And Mitigate Risks

Our expertise spans the entire drug development process, navigating challenges posed by globalization, stakeholder engagement, scientific innovation, and payer expectations.

OUTSOURCING MODELS

As The Pendulum Swings, More Sponsors Initiate Site Identification And Feasibility

Consultant Megan Liles has seen outsourcing shifts over the years but says this one feels different. Here, Liles explains why she believes sponsors will ultimately initiate site identification and feasibility before bringing a CRO on board.

Harnessing FSP Engagements To Deliver On-Time, On-Budget

The strategic use of FSPs helps biotech companies minimize risks, maintain compliance, and accelerate the development of life-changing therapies.

2024 Market Trends In Clinical Trials: Navigating The Future With Ease

Explore this year’s market trends survey for a comprehensive analysis of the emerging trends, evolving preferences, and key challenges set to shape the future of clinical trial processes.

The High Cost Of CRO Turnover (And How You Can Avoid It)

Though some turnover is an inevitable part of a business’s life cycle, there are several strategies available to ensure a consistent CRO team throughout the span of your trial.

Flow Cytometry Services

Experience customized, validated flow cytometry (FCM) biomarkers and panels for your clinical research on a global scale. Learn how FCM enhances your research and helps develop the panels you need.

How To Optimize Early-Phase Drug Development

Do you keep hitting roadblocks? Frustrated with all the paperwork? Let us help! Learn how Altasciences can provide a more seamless and efficient drug development experience.

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  • 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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