Newsletter | May 24, 2023

05.24.23 -- FDA Releases Draft Guidance On Decentralized Clinical Trials

Webinar: Big Roadblocks To Avoid When Implementing A New CTMS

Implementing a new CTMS requires engaged collaboration across multiple stakeholders. With the right planning, supporting expertise, and technology, organizations can shorten CTMS implementation and adoption timelines to achieve faster ROI. Join this webinar to learn the most common roadblocks that customers face when adopting a modern CTMS — and how to avoid them. Click here to learn more.

Decentralized Trials
FDA Releases Draft Guidance On Decentralized Clinical Trials

The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.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.

Finding The Right Balance Between Automation And Human Touch

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

Holistic Implementation Of DCT Elements Drives Modern Research

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.

Optimizing Strategies And Technologies For Decentralized And Hybrid Trials

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.

Giving Power To The Patient Voice: IRT And Direct-To-Patient Trials

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. 

Trial Management
Scaling Up Cell Therapy Manufacturing Capacity For Clinical Supply And Beyond

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.

Five Reasons To Choose Canada For Your Clinical Trials

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

The Importance Of Proper Clinic BP Assessment Methods

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

To Placebo Or Not To Placebo? The Great Debate In Rare Disease Trials

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.

Distribution Of The First Commercial CAR-T Therapy From U.S. To Japan

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.

Are We Ready For A Unified Clinical Platform?

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.

Study Design In Fountayn: Build Your Own Adventure
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.
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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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