Everything you expect from an EDC is here: eCRF, queries, SDV, signatures, the audit trail. On top of it, 11 things a typical old-school EDC does not have. Each already works in the portal, and each says where to find it.
The name has two words, and their order is not an accident. The person comes first: the one who enters the data, the one who checks it, and the one the data is about. The tool comes second. A good, precise, validated one, but a tool.
A clinical trial is a pact of trust. The EDC is the place where trust becomes data.
An old EDC does eCRF only. Everything else lives in separate systems, and data moves between them by exports and manual reconciliations. In YouEDC these are sections of one portal over one database.
The EDC and several more vendors next to it
One portal, one database, one audit trail
Short, to the point, and with the place in the portal where you can see it.
Upload the protocol PDF and get a draft of visits → forms → fields, with quotes and the contradictions found. A protocol amendment is compared with the current set-up.
Where: New study from a protocol; eCRF builder → Auto-setup log, Protocol amendments
A QA environment, UAT with steps made from the design itself and with signatures. Before the release the draft runs over the live data: you see which forms will turn into errors.
Where: eCRF builder → eCRF versions, test environment and UAT
The portal writes the package for GAMP 5, Part 11 and Annex 11 itself, the IQ report, a validation kit for every eCRF version and the DVP straight from the checks that run.
Where: Validation package, DM documents · more on validation
Capture, Safety (pharmacovigilance, E2B, DSUR), TMF, Trials (monitoring, CTMS), Supply (drug supply), Biostat.
Where: the section switch at the top left · the diagram above
Minimisation and blocks, a run of the scheme on invented patients before the start (balance and predictability), emergency unblinding.
Where: Capture → Randomisation
The statistics count themselves, straight from the study's data as it is now. No waiting for an export, no programs to write, no tables to assemble: open the page and see enrolment, how patients take part, the key variables over the visits, adverse events and time to event, by arm. A PDF report in one press.
MedDRA and WHODrug under the customer's licence, ATC, ICD, plus SDTM, ADaM, Define-XML and aCRF.
Where: Capture → Medical coding; Studio → CDISC: SDTM, ADaM, Define-XML
ePRO as a PWA works without the internet, sign-in by QR code and PIN. A tablet at the site, a legal representative, reminders by e-mail and SMS, remote consent.
Where: Capture → ePRO adherence, Informed consent · more on ePRO
Lab results are read from the laboratory's PDF and from a photo of the form; import from the medical record by FHIR and SEMD, device data, an API.
Where: Capture → Lab documents, Health records (FHIR), Device data, API
Data analytics (outliers, trends), audit trail review by E6(R3), lock readiness by site, a weekly report to the sponsor and scheduled data delivery to SFTP, bulk DCRs. Plus a DM assistant that runs on a local model only.
Where: Studio → Data analytics; Capture → Central monitoring, Audit trail review, Status report, Data deliveries, Data change requests
2FA, SSO (SAML/OIDC), field encryption of personal data with AES-256 in the application (152-FZ, GDPR), an inspector role with an end date, access review with a signature, automatic lock of unused accounts.
Where: Profile; Project settings → Security, Team
| Task | A typical old-school EDC | YouEDC |
|---|---|---|
| Set up a study | by hand from the protocol, weeks | a draft from the protocol PDF, with quotes |
| Release an eCRF amendment | UAT in Excel, impact unseen | QA environment, signed UAT, a run over live data |
| Validation | written by the customer or the vendor for money | the package is written from the portal's data |
| ePRO, randomisation, safety | separate vendors and reconciliations | sections of one portal |
| Statistics | after the export, weeks later | online, on live data, by arm |
| SDTM and coding | outside, in separate tools | inside the portal |
| Lab results | manual entry | from PDF and a photo of the form, FHIR, SEMD |
| Sponsor report and data transfer | by hand in Excel | on a schedule, by itself |
| Sign-in and access | a login and a password | 2FA, SSO, encryption of personal data, access review |
We compare with a typical old-school EDC, not with every system on the market.
We have double data entry from paper, but old EDCs have had it for a long time, so it is not on this list. Some vendors have randomisation and ePRO, usually as a separate module.
The DM assistant and AI reading of the protocol run only on your installation's local model and are switched on separately. Patients' data never goes to third-party clouds.
YouEDC Biostat shows descriptive statistics of the current data. It does not replace the analysis by the statistical analysis plan and does not prove efficacy.