Newsletter | October 17, 2024

10.17.24 -- Why Moving More Cancer Trials Into The Community Benefits Patients And Sponsors

SPONSOR

With ICH M11 expected to be adopted by the end of the year, the next Clinical Leader Live digital event will host a panel discussion on the advantages of improving and simplifying the dataflow of clinical trials but also the challenges associated with creating a connected digital dataflow, including digital health channels, that spans from protocol to data collection to CSR. Register today and join us on 10/31 at 1 pm ET (10 am PT).

OUTSOURCING MODELS

Why Moving More Cancer Trials Into The Community Benefits Patients And Sponsors

Guest Column | A conversation with Amita Patnaik, MD, START Center for Cancer Research

Amita Patnaik, MD, recounts the growth and necessity of START’s locations and site network amid the perpetual need to bring clinical research, especially for cancer, closer to patients.

The Unique Value Of Integrated Safety Services And Technology

White Paper | By Archana Hegde, Richard D’mello, and Scott Fonseca, IQVIA Safety & Regulatory Compliance

In your search for an integrated safety partner, begin by assessing a vendor’s previous experience and whether their PV knowledge aligns with the needs of your product portfolio.

SMART First Human Dose (FHD)

Brochure | PCI Pharma Services

A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.

Addressing Top Concerns And Unmet Needs In Oncology Research

Brochure | Worldwide Clinical Trials

Discover how over 140 global clinical outsourcing decision-makers view their key challenges and see why many oncology trial sponsors are turning to flexible, personalized solutions for greater stability.

REGULATORY & COMPLIANCE

Research, Manufacturing, Regulatory, And More: What Are The Challenges With CGTs?

Guest Column | By Roger Palframan, UCB

UCB Head of U.S. Research Roger Palframan discusses the challenges with CGTs — from complex manufacturing to the need for greater and more meaningful patient engagement to evolving regulations and reimbursement.

Lessons On The Use Of RWE In Regulatory Submissions

Article | By Martin Roessner, David Brown, and Sheng Feng, Ph.D.（冯胜）, Parexel International

Read along as authors share their most significant lessons, offering guidance on how to harness the full potential of RWE to drive innovation and efficiency in drug development.

Unveiling The Potential Of Psychedelic Therapies

Article | Avance Clinical

Leading experts highlight the transformative potential of the rapidly evolving field of psychedelic therapies and underscore the importance of rigorous clinical trials and regulatory compliance.

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