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by sudhirj 2194 days ago
> supports trial execution, 21 CFR Part 11 compliant remote data collection, telemedicine, biostatistics, sample kits for at-home specimen collection, and protocol writing.

Does that not make sense to people in this field?

2 comments

Depends what you mean. I'm a software engineer working on clinical study software and it makes sense to me. Though, I'm sure there are plenty of problem spaces that I don't work in whose jargon wouldn't make sense to me.

Here's a brief breakdown of the various terms though:

> trial execution

The act of running the clinical study.

> 21 CFR Part 11 compliant remote data collection

21 CFR Part 11 compliance is a set of standards that must be adhered to when running clinical studies. To be compliant means you meet these standards and people or businesses that want to run studies can be sure that you're following the rules.

> Telemedicine

Medical visits typically done over video chat / phone calls or other digital means as opposed to going physically somewhere to be tested or evaluated.

> Biostatistics

Data science + medical data

> Sample kits for at-home specimen collection

Like 23&Me but for collecting other stuff from people at their homes. E.g. stool samples, COVID-19 swabs, etc. You mail the participant a kit, they collect their sample, mail it back to you, you process the sample, and that informs the data in your study.

> Protocol writing

Writing and codifying the procedure of how the clinical study will be run. Covers everything from enrollment, inclusion / exclusion criteria for the study, study running, and study closing and archiving.

Who and what field? If you mean programmers and regular HN visitors then no, those words have no meaning for me. What does each one mean and why is it important for running medical trials? Other than protocol writing, which sounds like a list of rules, I have no idea what the rest means or why it would be important in a trial.