Invio Sponsoring the Seattle BioTech & Bagels Morning Meetup

Invio’s proud to sponsor the Seattle BioTech & Bagels Morning Meetup. Started in early 2017, they meet in the biotech-laden South Lake Union neighborhood of Seattle to mix and mingle monthly. This meetup is perfect for those in the exciting intersection between life sciences and technology. Seattle is arguably one of the top cities for growth thanks to the confluence of top universities, hospitals, research institutes, and a vibrant biotech startup community. Now is the right time to cross-pollinate these sectors through a centralized networking group. Meet local Biotechnology and IT professionals, entrepreneurs, and enthusiasts to network and discuss healthcare IT, medical devices, cell biology, life science research, clinical trials,… Read More

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Cloud-Based Monitoring Perspectives and Best Practices – ACRP

This weekend’s ACRP in Washington, DC is a special one as Invio’s CEO Dema Poppa will be co-presenting with Ron Carozza, the Director of Clinical Operations and Co-Founder of C3 Research Associates. We’ll cover case studies of cloud-based monitoring and a conversation about how different stakeholders can cooperate to increase research effectiveness. The speakers will explore remote monitoring from the perspectives of the contract research organization, research site, and technology vendor. Expect to learn about the impact of HIPAA-compliant, cloud-based subject binders, associate regulatory issues such as Certified Copy, and best practices for implementation. Our session will be in National Harbor 12-13 on Sunday, April 29th from 3:30 PM – 4:30… Read More

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Part 3: What’s Possible with Certified Copies of Source Data?

Let’s do a quick compare and contrast between FDA and GCP definitions to understand better what is possible with Source Data. Critically, both definitions address changes from paper to electronic; FDA in a specific parenthetical, and GCP in a general sense about “type of media used.” They both care about having the same information verified, though FDA requires a dated signature, whereas GCP allows “a validated process.” So, what does this mean? One common practice that falls apart under this analysis is the wholesale printing of EHR records. Unless EHR records are being certified after printing, they don’t fall under the definition of Source Data asserted under FDA guidance or… Read More

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Part 2: What is Certified Copy?

As we talked about in part 1 of this blog series, paper presents an ongoing source data monitoring challenge, especially for multicenter clinical trials. Certified Copy exists as a regulatory mechanism by which we can replace paper records with electronic ones – or prevent them from being printed at all. To understand HOW, let’s examine this where it begins: at the source (literally). FDA’s guidance Electronic Source Data in Clinical Investigations defines “Source Data” as: “All information in original records and certified copies of original records of clinical findings, observations, or other activities (in a clinical investigation) used for the reconstruction and evaluation of the trial. Source Data are contained… Read More

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