Newsletter | May 20, 2020

05.20.20 -- What To Expect From The FDA During (And After) COVID-19

 
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Strategies For Efficient Clinical Supply Management And Forecasting

Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.

Industry Trends In Clinical Development Technology

There’s no question that technology is continuously becoming more embedded throughout the clinical development process. The use of electronic data sources is no exception. More systems, processes, files, storage, and approvals are moving away from paper-based methods and toward applications that utilize electronic sources of data.

Clinical Delivery Within COVID-19: We Have The Ability To Adapt

The clinical research industry has dabbled in the virtual space for some time now, cherry-picking low-priority studies to test artificial intelligence platforms and home healthcare nursing options. But today we find ourselves squarely facing the impossibility of continuing as we always have — as with the frontline healthcare professionals, we must adapt immediately to a virtual environment to protect the well-being of research subjects.

Ticking Boxes: Immuno-Oncology Trials Checklist

Because of its promising outcomes, immuno-oncology is a significant and growing segment of clinical research, but one that does not come without challenges. Following the guidelines for best practices within immuno-oncology trials can be made easier by following this comprehensive checklist.

COVID-19 Regulatory Developments Impacting Technology Use In Clinical Trials

In light of the recent disruptions and challenges posed by COVID-19, there has been an increase in activity in promoting the use of technology in clinical trials. This blog reviews recent statements from the FDA (U.S. regulator), MHRA Inspectorate (U.K. regulator), various institutional review boards (IRBs), and ACRO (Association of Clinical Research Organizations) regarding the current situation.

The Trials Of The Future Are Needed Now

A paradigm shift is underway in the world of clinical trials as more and more CROs and pharma companies investigate some type of decentralized trial. The adoption of novel approaches has been slow, but the COVID-19 pandemic has changed everything.

Rideshare: Taking Clinical Research By Storm

The new-age transportation method, Rideshare, is growing in popularity among everyday travelers, but it has also been found to provide significant advantages for clinical trials. This blog outlines ten benefits of utilizing Rideshare through an expert provider in clinical workflow optimization.

Unpicking The Complexity Of Importer Of Record Processes In Globalized Clinical Supply Chains

Embracing Importer of Record best practices is key to reducing risk and promoting timely and compliant supply to patients enrolled in global clinical trials. Download Almac’s white paper for information on how to embrace safe, efficient and cost-effective, global supply chain operations, through the COVID-19 pandemic and beyond.

Clinical Trial Disclosures On The World Map

TrialScope Chief Strategy Officer Thomas Wicks discusses the changing nature of clinical trials: how they are conducted, reported, and regulated, along with compliance issues. Listen now.

Avoid Rescue Studies, Reduce Costs And Timelines, And Accelerate Clinical Operations With Metrics

You can’t manage what you don’t measure. Having technology that can automate or assist in the timely monitoring of trials is a huge improvement over the status quo of manual methods such as spreadsheets, which are cumbersome and erroneous, not to mention only provide a dated snapshot of trial performance.

Experts From China Speak On Conducting Clinical Trials During Covid-19: Part 2

In this follow-up to our first DIA DIRECT COVID-19 webinar, join us to hear experts from China answer your questions about conducting clinical trials during the pandemic. Representatives from across various healthcare product development functions will discuss steps currently in place to ensure safety and efficacy of clinical trials continuing through COVID-19.

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June 14 to 18, 2020

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