Featured Articles
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Best Practices For Participant Safety: Assessment, Documentation & Reporting Of Adverse Events
6/24/2020
Identifying and monitoring adverse events (AEs) is critical to protecting research participants and ensuring the integrity of the research trial. This whitepaper examines key aspects in adverse event identification and monitoring, with a specific focus on IND studies, incorporating an unfolding case study after the expedited reporting information is shared.
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21 CFR Part 11 Compliance For Clinical Research Sites
6/24/2020
Understanding and following the detailed regulations around 21 CFR Part 11 requires a significant amount of time, resources and knowledge. We’re here to pass along to you as much of this information as possible so you can navigate with ease everything required for compliance – including validation, training and process development.
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How to Attract Sponsors & CROs: 3 Lessons From Top Clinical Trial Sites
6/23/2020
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.
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Using Remote Clinical Research Site Monitoring During COVID-19
6/23/2020
Here are some of the challenges that research sites and monitors are facing right now – and how they can overcome them with remote monitoring.
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What Goes Into An Investigator Site File?
6/23/2020
The investigator site file (ISF) plays a critical role in a study’s success. But only if clinical trial investigators keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF.
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Leveraging eRegulatory To Improve Remote Monitoring
6/23/2020
Remote monitoring technology initiated by sponsors can often inflict additional burden on sites, requiring them to not only print and file their regulatory documents, but scan and upload them to multiple sponsor portals, too. Fortunately, sites are beginning to identify more efficient ways to enable remote monitoring.
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eRegulatory Binder Checklist: What Does The FDA Require?
6/18/2020
eRegulatory binders help clinical sites organize and digitize the regulatory process. In this post, we take a brief look at what every FDA-regulated binder needs to have.