Newsletter | July 22, 2020

07.22.20 -- Is Pharma Ready To Embrace Virtual Trials?

 
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Industry Insights
The Top 5 Questions To Ask When Developing A REMS

Unsure if a REMS (risk evaluation and mitigation strategy) is needed during product development? This article will answer that question and give guidance as to when implementing a REMS is necessary.

Big Data Powers Insights For COVID-19

One challenge facing the research community today: acquiring meaningful data sets on the COVID-19 pandemic. Read how technologies and workflows can be combined to provide a solution.

A View From The Clinical Floor

Adaptive designs allow more flexibility and control over the trial and, hopefully, will lead to defining the optimal strategy for the given therapy. Bayesian statistics is likely to dominate the future standard of trial design but does involve change in how clinicians interpret the results.

Seven Reasons To Consider A Just-In-Time Manufacturing Approach For Your Clinical Trial Supplies

Evaluating the potential that modern drug production methods offer, in terms of increased supply chain optimization and agility, is essential for sponsors. Read Almac’s article to find out how just-in-time manufacturing can help deliver a flexible, continuous, and cost-effective clinical supply chain operation.

ChromoReport Winter 2019: Proactive Planning With Predictive Analytics

Complexity in clinical trials continues to grow a confluence of globalization, outsourcing, protocol complexities, and ever-increasing regulatory mandates. The preliminary step of all clinical trials is study start-up, which is widely recognized as a costly and perpetual bottleneck. Today we have web-based maps that are always up to date and supplemented with satellite images and crowdsourced, real-time information. What if you had this kind of navigation for study start-up?

Clinical Data Aggregation

Learn about the challenges for sponsors and CROs when integrating a vast array of data sources and typical relational database structures and why they don’t work for clinical analytics, as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.

Protected Ambient Sample Shipping

A leading pharmaceutical research company needed help supporting a two-year clinical study of progressive multiple sclerosis. In order to accommodate multiple sampling time points, the shipping kit needed to hold up to 17 test tubes in isolation, instead of the standard six or seven, and needed to maintain the test tubes within a very limited target temperature range despite exposure to extreme heat or cold for extended periods of time.

Agile Drug Development Required In A New Age Of Urgency

It’s time to reconsider the current paradigm of drug development, clinical trials, and regulatory approvals.

Strategies To Optimize Trial Performance And Quality

Modernizing clinical trials is possible with a focused effort and in this eBook, we present real-life examples of select Medidata customers who have aligned the right technology strategies with their business priorities to optimize trial performance and data quality.

Why Choose An FSP Model?

Learn the benefits of using a functional service provision (FSP) model, such as increased resource flexibility, access to specific skills and expertise, access to technology, improved service provider relationships, and lower costs.

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