05.24.23 -- FDA Releases Draft Guidance On Decentralized Clinical Trials

The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.

Is your team preparing to launch a decentralized clinical trial? Learn how to maximize research efficiency, quality, and value while ensuring consistency and integrity.

A DCT approach incorporates flexibility into trial designs, expanding patient choices and extending a human touch into patient homes by replicating services normally performed on-site.

Examine several considerations that should be taken when selecting a technology platform that can create operational efficiencies, reduce site burdens, and ensure accurate data collection.

Want to know more about the growth and expansion for IRT in the decentralized trial space? Witness how IRT is being used to support direct-to-patient delivery in this hybrid trial case study presentation. 

Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk while ensuring flexibility to respond to patients’ needs.

Understand the conduct of clinical trials in Canada and learn five key reasons why you should choose Canada for your next trial.

Learn why clinicians prefer validated automated oscillometric blood pressure devices to assess brachial blood pressure.

Consider the severity of the disease, the availability of existing therapies, and more when deciding whether or not to use placebo controls in rare disease trials.

Observe the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a U.S. manufacturing site to a hospital in Japan.

Industry experts share their perspectives on end-to-end clinical development, essential elements of a unified clinical platform, and the benefits and challenges involved in a unified clinical platform.

Discover how Fountayn’s study team supports clinical teams from the trial build, start-up, administration, training, and design changes to data archiving and closing procedures.