Newsletter | February 17, 2021

02.17.21 -- Why Did Veeva Become A Public Benefit Corporation?

 
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Does Warp Speed Vaccine Development And Testing Compromise Safety?

Fiction often shows warp speed travels not going as planned, but what does warp speed mean for vaccine development in clinical research? Compared to the processes of 20 years ago, development of the current SARS-CoV-2 (COVID-19) vaccine candidates has been remarkably swift thanks to genetic engineering and the additional resources afforded via Operation Warp Speed. Is this new approach used to develop COVID-19 vaccines safe?

How Open Approaches And Interoperability Enable A Better Ecosystem For Clinical Trials

As pharma companies and CROs around the world continue to adapt to running trials in this new COVID-19 environment, they are taking this time to reassess the status quo of their technology installations. It’s times like this when you can really delve deep into assessing how “open” or “interoperable” a system really is.

Best Practices For Site Communications During COVID-19

With so much new and updated information being shared on nearly a daily basis, it’s important to consider the most effective methods of organization and distribution. Here are some best practices we’ve compiled from working with sponsors and sites of all sizes and specialties during the COVID-19 pandemic.

Virtual Absolution: How Trial Sites Adapted To COVID-19

COVID-19 accelerated interest in the use of virtual trials as a way to keep trials running through the pandemic. It was an unexpected shift, but it has helped many sponsors and sites see the value of virtual for clinical research and identify where and when virtual trial elements may bring permanent benefits to clinical research, even after the pandemic is over.

Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct

As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.

The 3 Cs You Should Expect From Your Pharma Service Provider

When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.  

Implementing Remote Trial Management: Proven Approaches For A Quick And Effective Launch

Remote trial management has never been more critical to ensure flexibility in your clinical operations. Industry experts Penny Manasco and Michael Smyth discuss key considerations for effectively launching remote trial management for current or upcoming studies. Learn how to choose a vendor that can provide you with the right solution to not only ensure your clinical trials maintain accuracy and compliance as they go virtual, but also help you innovate your approach to clinical trial management.

The Use And Value Of Blockchain In Healthcare Research

This article introduces blockchain technology in the context of healthcare research, the opportunities and value it is set to provide in the future, and how to overcome the obstacles of implementing it.

How To Attract Sponsors And CROs: 3 Lessons From Top Clinical Trial Sites

Competition in the clinical trials landscape is fierce. For sites looking for more studies, it can be difficult to capture the attention and trust of sponsors and CROs. In this post, we break down what sites should do to keep their study pipeline full.

Warming Up To Hybrid Trials

In a November 2020 survey, Industry Standard Research (ISR) asked 121 clinical trial outsourcers at sponsor companies a series of questions about their company’s use of hybrid trials. This article offers insight on the prevalence of use, respondents’ overall impressions, and the concerns and downsides of hybrid trials.

Comparator Local Sourcing For Clinical Trials

The growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.

IRB Performance And Best Practices In Site Start-Up: Review Of Two Recent Market Research Reports

ISR will review findings from two recent, high-profile pieces of market research. One details the performance of specific institutional review boards (IRBs) in the clinical development space across such metrics as timeliness and responsiveness of protocol review and local IRB/regulatory knowledge. This report also highlights trends impacting how companies interact with IRBs — mainly the need for improved use of technology. The other report is an in-depth look into what CROs and sponsors are doing, what’s working, what’s not working, and what’s next in their quest to increase the efficiency and effectiveness of site start-up activities in clinical development.

Beyond Brexit: What Now For Clinical Supply Across Europe?

After three years of Brexit withdrawal negotiations, the U.K. is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU and U.K. can be reassured that the U.K. will remain part of the current trade arrangements, customs union, and single market until the end of the transition period on December 31, 2020. This panel presentation will explore the early analysis of potential Brexit challenges that sponsors face and the strategic solutions that can support sponsors in a post-Brexit world.

Driving Trial Efficiency, Speed, And Quality: AstraZeneca’s Clinical Transformation Journey

Improving trial execution requires coordination across many areas. As companies look to modernize clinical operations, a strong technology foundation, seamless integration across systems, end-user ease of use, and operational process improvements are all important considerations to accelerate drug development. Watch this on-demand webinar to hear AstraZeneca's strategic vision and journey to transform clinical operations — from enhancing ways of working, to redefining clinical trials, to reimagining healthcare.

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