Newsletter | May 14, 2025

05.14.25 -- Medtech CEO Shares Lessons From FIH Implantable Glucose Monitor Trial

TRIAL MANAGEMENT

Medtech CEO Shares Lessons From FIH Implantable Glucose Monitor Trial

Guest Column | A conversation with Paul Goode, Ph.D., president and CEO, Glucotrack

CEO and President Paul Goode, Ph.D., explores the implantable CBGM’s trial design, as well as the company’s approach to patient input, site selection, and more for its first-in-human trial.

Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology

White Paper | By Robert Rissmann, Matthijs Moerland, and Martijn BA van Doorn, CHDR

Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

Journey Of A Therapeutic Antibody

e-book | By Amanda Woodrooffe, Ph.D. and Rachel Owen, Ph.D., Precision for Medicine

Delve into the early development journey of a therapeutic antibody and learn about the critical role of robust biomarker strategies and analytical assays.

5 Key Considerations For Choosing The Right ERP

Article | By Jim Ingram, Sikich

Selecting an Enterprise Resource Planning (ERP) system is a pivotal decision for life sciences organizations, influencing regulatory compliance, operational efficiency, and long-term growth.

Strengthening Pathways For Cell And Gene Therapies

White Paper | IQVIA Biotech

This report aims to spur informed discussions on the future trajectory of cell and gene therapies and their pivotal role in shaping the future of healthcare.

DECENTRALIZED TRIALS

Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance

Guest Column | By Balaji Maddiboyina, Freyr Solutions

In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.

Patient Trust And Engagement In The Age Of Decentralized Trials

Article | By Mike Stratton, CSSi - An Elixia Company

Decentralized trials are transforming the landscape of clinical research by enhancing awareness and accessibility.

Remote Services And Technology - Regulatory Clarity For Investigators

Article | By Jimmy Bechtel, The Society for Clinical Research Sites, DIA

By focusing on updating regulatory frameworks, developing technical standards, and leveraging technology for compliance, see how the industry can ensure safely and ethically trial conduct.

The Crucial Role Of Mobile Visits In A DCT For Interstitial Lung Disease

Article | PCM Trials

Decentralized clinical trials (DCTs) are revolutionizing patient participation by bringing clinical research directly to participants' homes through mobile research nurses.

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