Newsletter | July 1, 2019

07.01.19 -- Humans And Machines Will Partner For Better Outcomes

Featured Editorial
Humans And Machines Will Partner For Better Outcomes
By Ed Miseta, chief editor, Clinical Leader

Dr. Emmanuel Fombu spends a lot of time thinking about healthcare. He’s a trained physician and currently leads global strategy and digital innovation at Johnson & Johnson. He would like to see better roadmaps in healthcare that lead us to determining a patient’s level of health. Currently, your doctor asks a question, you supply an answer, and this begins the process of trying to figure out what might be wrong with you.  

Leveraging AI To Assess Clinical Trial Technologies
By Jeffrey S. Handen, Ph.D., and Nate Regimbal, Grant Thornton LLP

As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

Industry Insights
4 Potential Advantages Of Adaptive Design
Article | By Thomas Laage, M.D., Premier Research

Adaptive design strategies have been especially useful for rare disease research in general and rare oncology in particular. Read more to see how the savvy application of adaptive trial design compares to conventional study designs.

How To Survive An FDA Audit
White Paper | By Paul Dupont, Ropack Pharma Solutions

Understanding the FDA audit process, preparing for it, and being aware of regulations will help to restore a sense of control and the best outcome.

Reducing Cost Within Advanced Therapy Clinical Trials
Case Study | By Simon Ellison, Thermo Fisher Scientific

The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, we’ll demonstrate how a company saw 55 percent cost savings across its distribution system and increased visibility of its supply chain through meaningful data by partnering.

eCOA Solution In Pediatric Clinical Trial Reduces Burden On Caregivers
Case Study | Signant Health, formerly CRF Bracket

In this example of eCOA in a rare disease clinical trial, handheld devices reduce the burden of data collection for caregivers of children.

AI Research Can Optimize Clinical/Operational Effectiveness
Podcast | DIA

“One critical area when you look at healthcare systems is the issue of optimizing clinical and operational effectiveness,” suggests Professor John Lim, founding executive director of the Duke-National University of Singapore Centre of Regulatory Excellence (CoRE). Professor Lim is also chairman of the Singapore Clinical Research Institute and National Health Innovation Center.

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