Newsletter | May 23, 2023

05.23.23 -- New FDA Framework: Use Of Digital Health Tech In Drug Development

 
     
 
     
 
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A single trial design misstep can halt a product’s clinical progression, while an informed clinical strategy, which leverages input from patients, regulators, site staff, and other stakeholders, can help teams improve decision-making and outcomes. Join Clinical Leader Live on June 14 as we bring together veteran drug developers to discuss what to do, and what not to do, when designing a clinical trial protocol.

 
 
     
 
Clinical Trial Technology
     
FDA Publishes Framework For Use Of Digital Health Tech In Drug Development
 
 

In March 2023, CDER and CBER published Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.” Here is what you need to know.

 
 
 
 
     
Revolutionizing Ophthalmology Studies With Technology
 
 

Efficiencies in ophthalmology studies can be improved in a variety of ways. Learn how technology can help researchers to accelerate the pace of research, improve the quality of data, and reduce costs.

 
     
A Sponsor’s Commitment Drives Global Site Adoption And Process Optimization
 
 

A global Top 10 pharma sponsor needed a provider whose core focus was on patient payments with heightened functionality and centrality. Find out the solution they turned to in order to solve this need.

 
     
Perfusion MRI And Other Perfusion Imaging Techniques For Clinical Trials
 
 

Read about perfusion imaging techniques and their use for clinical trials, with a particular focus on perfusion imaging using DCE-MRI.

 
     
Key eTMF Elements And Practices For High-Volume, High-Quality Processing
 
 

In an ideal scenario, the eTMF would operate like a well-oiled factory. Examine some of the factors that would support making “The eTMF Factory” a reality.

 
     
Start Smart: A Solution Suite For Complex Clinical Studies
 
 

IQVIA Asset Maximizer is a comprehensive suite of solutions that intelligently connects insights, technology, and expertise to maximize your asset's probability of success in a complex and competitive environment.

 
     
The Medrio Electronic Patient Reported Outcomes Platform
 
 

With Medrio's combination of technology and consultative support from our team of experts, you can experience a seamless ePRO transition and establish a smoother path to regulatory submission.

 
     
     
 
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