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Manual Clinical Trial Admin
Clinical research staff are overwhelmed by manual, repetitive, and poorly coordinated administrative and data tasks that lack integrated tooling.
In their words
management has asked me to build them a secure database, something the organisation genuinely owns and can build on for future studies, rather than just Excel files in SharePoint
how are you guys handling bulk participant consent without manually emailing hundreds of pdfs?
we really liked Mosio but the PI wanted us to "really think if this is something that adds value" before biting the bullet on ~$1200/year
all study docs will be in Spanish and our CMS doesn't offer bilingual/translation for their monitoring efforts
It was already a stretch getting parents to take a day off of work to volunteer.
a lot of the workflow behind it is still manual and fragmented
Clinical trials still run on a messy mix of legacy EDC systems, PDFs, lab reports, imaging reports, safety databases, spreadsheets, vendor portals, protocol deviations, reconciliation, and query management.
Clinical trials still run on a messy mix of legacy EDC systems, PDFs, lab reports, imaging reports, safety databases, spreadsheets, vendor portals, protocol deviations, and endless query management.
the bioinformatician gave us with no transparency what was actually done
clients have slowed regulatory review so much that the data and references literally change out from under us
at our trust the process is bonkers and I'm trying to offer alternative ideas to the study leave team
There’s no way of excluding participants so we risk our data / products being informed by the exact same group of people.
But the workflow to access drugs via clinical trial is terrible. Directions/Instructions aren't documented. Unwritten limitations and optimizations.
I initially started because I needed a dataset browser. I work with clinical trials, so we usually get raw data files in all possible formats
Clinical research site staff
Where they talk
- r/clinicalresearch
- r/biotech
- r/AmazonFC
- r/ProjectREDCap
- r/publichealth
- r/research
- r/medizin
- r/grc
Tools they use today
- EDC
- CTMS
- Excel
- Microsoft Teams
- REDCap
- Advarra
- Claude
- SharePoint
Why those fall short
- data checks and queries are wrong, vague or not enforced
- re-scanning and retraining required for every new activity or group
- urgent emails, duplicate requests, unclear timelines, no prioritization
- no study-specific filing plan up front; generic reference model only
- no automated check that documents are IRB approved
Map of ideas
Drawing the map…