Newsletter | January 15, 2025

01.15.25 -- We Are All Project Managers, But We Need Help

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TRIAL MANAGEMENT

Were There Any Surprises In Clinical Trials In 2024?

Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once? Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.

Navigate Licensing Laws And Regulations On DCTs Across State Lines

Take a deep dive into the various laws and regulations surrounding multistate licensing for clinical research and explore additional considerations to set you and your study up for success.

The Final DCT Guidance: I'm Not Mad At It

Explore the FDA's 2024 final guidance on DCTs, including key updates that address previous concerns, affecting healthcare providers, sub-investigators, and sponsors.

Mobile Research Units Enable Large Volume Screenings

Learn how recruitment and screening of potential patients was made possible for a Phase 3, adult patients, clinical trial by utilizing MRUs to screen large volumes of patients at community events.

DECENTRALIZED TRIALS

We Are All Project Managers, But We Need Help

Jess Thompson is a champion of project managers. Not only is she working to validate their role in the clinical trial ecosystem, she wants to spread the word that we all perform PM-types of duties. Also, if the industry can improve its incorporation of those basic tenets of project management, perhaps we could see more drugs succeed — and quicker.    

Uncovering The Root Cause Of Clinical Trial Troubles

Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.

'Diabesitology': Novel Trial Designs In The GLP-1 Axis Medications Era

Find out how today’s FDA-approved obesity medications are primed to become tomorrow’s novel treatments across multidimensional states of disease — from diabetes to heart failure.

Adapting Clinical Strategies For Rapid Response

This presentation aims to equip sponsors, researchers, and stakeholders with the tools to enhance trial resilience and ensure continuity in today’s unpredictable global landscape.

Select The Right BOIN Design For Your Oncology Study

Produce effective, reliable results in Phase 1 oncology trials with Bayesian Optimized Interval (BOIN) designs. These designs enable you to determine the MTD or the OBD with ease.

Toxicokinetics, Pharmacokinetics, And Pharmacodynamics

Discover why gathering and analyzing pharmacokinetic (PK) and pharmacodynamic (PD) data is key — from preclinical studies right to clinical trial conduct.

Launch Strategy & Planning

Read how IQVIA Biotech can help you integrate recent market dynamics and longer-term trends into your launch strategy for a precise understanding of launch risks and expectations.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.

  • 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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