Submission-ready qualification records. Without the last-minute scramble.
Consivera keeps every external consultant's CV, GCP certificate, training and vendor documentation current and audit-ready — and tells you what's missing or expiring before your submission or inspection, not during it.
Dr. Elena Vargas — Regulatory Affairs
CV · GCP certificate · Training — all current
James Okoro — Medical Writer
GCP certificate expires in 14 days
Priya Nair — Clinical Study Manager
Training record missing
The documentation scramble is real — and it always hits at the worst time.
When an FDA or EMA submission lands, or an inspection is announced, someone has to prove every external consultant was qualified and trained: an up-to-date CV, a valid GCP certificate, training records, vendor qualification documentation. For GCP compliance, it's not optional.
And it's almost always scattered — across inboxes, SharePoint folders and spreadsheets — chased in a panic in the final days before the deadline. A single missing or expired document can delay a submission or trigger an inspection finding.
The documents were never the problem. Knowing what you have, what's current, and what's missing — that's the problem.
Ready before you need it.
Each external consultant in one place — CV, GCP certificate, training records, vendor qualification. Upload, or let them submit their own.
We track expiry dates and flag what's missing or out of date — automatically — so nothing quietly lapses between engagements.
When a submission or inspection comes, the complete, current documentation set is already there. No scramble, no chasing.
Built for the documentation that trips up small teams.
Qualification tracking
CV, GCP certificate, training and vendor documentation, per consultant.
Expiry alerts
Know before a certificate or insurance lapses — not after.
Gap detection
See exactly what's missing before a submission, not during it.
Audit-ready export
A complete, inspection-ready pack in one click.
Self-submission
Consultants upload and update their own documents; you just review.
Cross-border check
Flags arbejdsudleje / economic-employer risk when consultants work across borders — the layer the big systems skip.
For the lean teams the big systems overlook.
Small and mid-size biotechs, CROs and clinical consultancies that run trials with external specialists — and don't have a six-figure eTMF system or a dedicated team to keep personnel documentation inspection-ready. If keeping track of your consultants' qualifications falls on one or two busy people, Consivera is for you.
Focused, light, and built for a small team.
| What matters | SharePoint & spreadsheets | Enterprise eTMF | Consivera |
|---|---|---|---|
| Keeps qualification docs current | Manual | Broad & heavy | Focused |
| Warns before documents expire | No | Sometimes | Yes |
| Shows what's missing before submission | No | Partly | Yes |
| Built for external consultants + vendors | No | No | Yes |
| Cross-border risk check | No | No | Yes |
| Affordable for a small team | — | No | Yes |
| Set up in an afternoon | — | No (months) | Yes |
Be ready before the deadline — not because of it.
We're building Consivera with a small group of early users. Join the waitlist for early access, a say in what we build first, and preferential pricing at launch.
Thanks — you're on the list.
We'll be in touch as early access opens. If you'd like to shape what we build first, just reply to the confirmation email and tell us where the documentation pain hits hardest for you.
Questions, answered.
Is this an eTMF?
Who holds the data?
When does it launch?
GDPR?
Ready before you need it.
Keep every external consultant's qualification documents current and submission-ready — automatically.