Newsletter | August 19, 2019

08.19.19 -- AbbVie Goes All-In On Wearables And Digital Technologies

Featured Editorial
AbbVie Goes All-In On Wearables And Digital Technologies
By Ed Miseta, chief editor, Clinical Leader

When working groups at AbbVie first began evaluating the use of digital technologies in clinical trials, the discussions were mostly conceptual. Individuals agonized over the right approach, the quality of the data, and whether the efforts would be accepted by regulators. Three years ago, the company decided to stop debating and start executing.

Email/Excel vs. Clinical Applications: What Do ClinOps Professionals Really Need?
By Thomas Cocciardi, LMK Clinical Research Consulting

The Veeva 2019 Unified Clinical Operations Survey examines the extent to which the clinical trial industry has sought to overcome its dependence on outmoded processes through the implementation of clinical applications. The survey’s main objective is to grow understanding of the “drivers, barriers, and benefits of a unified clinical operating model” through the exploration of clinical stakeholders’ attitudes about the clinical applications they currently use.

Industry Insights
Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments
White Paper | By Florian A. Quarré, Ciox Health - Life Sciences

Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.

Considerations For Working With Research-Naive vs. Experienced Sites
Article | By Jennifer Dennis-Wall, Ph.D., Biorasi

Some sites have a lot of experience, and those are generally sought after, but they can be busy running other trials and may not prioritize yours. It may be beneficial to include less-experienced sites in order to have better chances of enrolling. But of course, there are some necessary considerations when turning to these sites.

Is The Government Shutdown Already Impacting Drug Development?
Article | By Dr. Lindsay McNair, M.D., MPH, MSB, WCG

Insights into the impact that the shutdown will have on the FDA and on the review of investigational products, including those reviews which were already in process at the time of the shutdown. 

Service Excellence: The Cornerstone Of Quality Clinical Trials
Article | By Chris Flint, Cenduit LLC

Sponsors and CROs are not getting adequate eClinical technology service and support. This is especially true in the case of some providers who seem to have tacked IRT systems onto eClinical suites, almost as a checkmark, without forethought toward designing for change or potential protocol amendments along the trial’s life cycle. You need a solution with not only a technology that works, but also a team available that supports them every step of the way.

Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs
Article | By Simon Ellison, Thermo Fisher Scientific

While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated. In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.

Pooled Inventory And Just In Time Labeling (JTL) Meets Demand For Multiple Channels
Case Study | Almac Group

When a drug is required for both commercial and extended clinical trial use, this may cause strain on supply and demand operations. Discover how Almac Clinical Services used a pooled inventory strategy and a just-in-time labeling (JTL) approach to maximize drug supply and minimize wastage.

Advancing A Diabetes Multiregistration Program
Case Study | Covance

A large pharmaceutical company asked Covance to support their studies for a diabetes Phase 3 program specifically to register a drug to treat Type 2 Diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.

  Clinical Trial Supply Southeast 2019

October 2 and 3, 2019 | Durham, NC

CTS Southeast will return to North Carolina in 2019 to look at ongoing regulations, enhancing the supply chain, and making sure the right systems are in place. Top trial sponsors and regulatory bodies, such as GSK, G1 Therapeutics, PRA Health Sciences, GS1, and many more come together to share their insights into achieving a compliant and error-free supply chain.

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