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

Continue Reading

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

Continue Reading

Part 1: The Paper Problem

Paper presents an ongoing Source Data monitoring challenge, especially for multicenter clinical trials. Paper records are clunky, locked off on site, and not a particularly secure way to keep Protected Health Information (PHI). With all those drawbacks, why is paper so common in clinical trials? Having worked across many different sites, we see three common reasons we deal with so much paper: paper-originated source, electronic health records, and tradition. Paper-originated source is self-explanatory. It started that way – why change it? If you have a worksheet you filled out with a patient, it makes sense to just toss it into the subject binder and let the monitor worry about it… Read More

Continue Reading

Invio, Inc. selected for the Cedars-Sinai Accelerator Powered by Techstars

We’re proud to announce that Invio has been invited to the third cohort of the Cedars-Sinai Accelerator Powered by Techstars. Invio was one of only ten companies selected out of almost six hundred applicants, consistent with Techstars’ 1-2% acceptance rate. As part of the application process, our solution was validated against real-world needs at Cedars-Sinai. Additionally, our team was extensively interviewed to make sure we’d be a good match: they were “looking for focused, well-rounded companies with great teams, strong, thoughtful ideas and the ability to execute.” As part of this program, Invio will be spending Q3 2017 in the Cedars-Sinai Innovation Space in West Hollywood, California. There, we’ll be across the street… Read More

Continue Reading

A Focus on You

In enterprise software, users are not the priority they should be. Frankly, usability can be quite terrible. Daily users are often not the people making software purchasing decisions, so they get stuck using software that they would not choose. Usability suffers even more once you dig into more specific niches like clinical trial software. “Designing anything in a silo is rarely good, and never great.” We wanted to be different from the start and focus on delivering a great user experience. We believe that when you use SourceDrive it should be useful, fast, and intuitive. Features should make your day easier by eliminating the busy work of clinical trial workflows.… Read More

Continue Reading