Roadmap
What we have built and what comes next
We update this page as the work moves. Updated: 2026-10-04.
Done
Portal: the foundation
The new platform on PostgreSQL next to YouEDC 0.2: accounts, projects, team, audit trail, administration.
14 of 14 done
- Sign-up, sign-in, password reset, e-mails Portal
- Russian, English and French interface Portal
- DM desk: what needs a decision today, and portal search Portal
- Studies, sites, team, roles, invitations YouEDC Capture
- Hash-chained audit trail with a nightly check and CSV export YouEDC Capture
- One project mechanism: data collection in YouEDC Capture or DM work in YouEDC Studio, with one team, roles and audit trail Portal
- Administration: functions, limits, who uses what Portal
- Access to each function: personal and group rules, new accounts approved by an admin Portal
- E-mail confirmation at sign-up, protection from bots without outside services, deleting a user for good or anonymising with the audit trail kept Portal
- Branded e-mails in three languages, notifications in the portal, reminders only with consent and an unsubscribe link Portal
- Portal pages editor in three languages, with versions and audit Portal
- Validation kit (UAT/PQ): test scripts, a demo study, every step recorded, sign-off and a report Portal
- A demo project in one click: a study with invented data in every section (Capture, Safety, Studio, TMF) with months of history, deleted in one step Portal
- Study profile from lists (phase, design, area, population, countries, timelines), a passport in the project cabinet and a portfolio with charts, timelines and an Excel export Portal
In progress
YouEDC Capture: everything from YouEDC 0.2
The functions of 0.2 are already here. A few things remain, and the move of studies with their data.
13 of 19 done
- eCRF builder: visits, forms, fields, edit checks, form preview YouEDC Capture
- Subjects, the visit matrix, data entry with checks, the history of each value YouEDC Capture
- Queries (automatic and manual) and SDV by form YouEDC Capture
- Patient surveys (ePRO) by a personal link, no account YouEDC Capture
- Randomisation: minimisation, stratified blocks, the statistician's list, a simulator, two signatures, blinding, emergency unblinding, a replay check YouEDC Capture
- Import of CSV and Excel, exports to Excel, CSV and CDISC ODM 1.3.2 YouEDC Capture
- Serious adverse events from the forms flow into YouEDC Safety YouEDC Capture
- The data validation plan (DVP) writes itself from the eCRF builder: UAT test cases, versions, e-signatures, PDF/A into the TMF YouEDC Capture
- The investigator guide writes itself from the eCRF: the patient’s path, the visit matrix, fields and checks, versions, signatures, PDF/A into the TMF; the site reads it from a button in YouEDC Capture, confirms “I have read it” (training log into the TMF) and prints an A4 card YouEDC Capture
- Investigator e-signature (21 CFR Part 11): the whole patient or each visit, the password at signing, an optional hand-drawn picture, a data change withdraws the signature YouEDC Capture
- Patient casebook as PDF/A: a certified copy with the queries and the audit trail, a zip per site YouEDC Capture
- eCRF versions: testing, release with an e-signature, a draft of the next version, versions compared, deactivation instead of deletion YouEDC Capture
- Medical coding when a form is saved: adverse events, medical history and medications are coded at once, the rest waits for the coder; the dictionary on its licence holder's licence, sites never see codes; the AE code goes to YouEDC Safety and SDTM YouEDC Capture
- Coding, stage 2: a second-level review, queries to the site on unclear terms, the organisation's decisions, moving to a new MedDRA version with an impact analysis, WHODrug, figures YouEDC Capture
- Coding, stage 3: a dictionary of clinical wordings, misspelling suggestions with thresholds, the CTCAE grade from lab values YouEDC Capture
- Data management plan (DMP) from the portal's data YouEDC Capture
- Read-only API YouEDC Capture
- A YouEDC Capture study straight from the protocol analysis YouEDC Capture
- Move of studies and data from YouEDC 0.2 (accounts are already here) Portal
Done
YouEDC Studio: data manager's tools
For data from any EDC: MainEDC™ first, then Rave, InForm, Veeva, REDCap, OpenClinica and Excel.
18 of 18 done
- DM projects: dates, a shared task list, start-up and database lock checklists, archive YouEDC Studio
- A MainEDC™ export as it is: forms, subjects, visits, one Excel workbook for all the tools YouEDC Studio
- Data file profiler for exports from any EDC YouEDC Studio
- Protocol to study build: visits, forms and fields from the schedule of activities, protocol versions compared, eCRF specification YouEDC Studio
- eCRF specification check for other EDCs (Rave ALS, REDCap, Excel) YouEDC Studio
- Lab normal ranges per site with versions, out-of-range flags YouEDC Studio
- “What changed”: two exports compared, Excel report YouEDC Studio
- Query report: ageing, sites, hot fields, a sheet per site YouEDC Studio
- Data review with “reviewed” marks that carry over to the next export YouEDC Studio
- Cross-form checks: AE without medication and back, dates before consent and after end of study, visit windows, duplicates YouEDC Studio
- Overdue visits and missing pages against the schedule, by site and age YouEDC Studio
- Check effectiveness: which edit checks raise queries that change nothing, and which fields need a new check YouEDC Studio
- SAE reconciliation: safety database against EDC, comments carried to the next round YouEDC Studio
- Vendor reconciliation: central lab, ECG, PK against the EDC YouEDC Studio
- Medical coding: ICD-10-CM, CTCAE 5.0, UCUM and an ATC demo built in; MedDRA, ICD-10, ГРЛС loaded from the licensee's files YouEDC Studio
- Database lock readiness: blockers, counts per site, report YouEDC Studio
- Converter from an export of any EDC to CDISC ODM 1.3.2 YouEDC Studio
- CDISC pipeline: SDTM, ADaM (XPT, Dataset-JSON, Excel) and Define-XML 2.1 with a check report YouEDC Studio
In progress
YouEDC Safety: pharmacovigilance
Serious adverse event cases of the studies, their Day 0 and deadlines.
8 of 9 done
- Case queue and intake: the four minimum criteria of a valid case, a decision on every report YouEDC Safety
- Reports from YouEDC Capture, from SAE listings of other EDCs (MainEDC™ first) and by hand YouEDC Safety
- Day 0, SUSAR rules, 7- and 15-day deadlines, follow-up versions, reminders YouEDC Safety
- Narrative, discussion and e-signature of a case YouEDC Safety
- CIOMS I form and ICH E2B(R3) export YouEDC Safety
- A “New case” button in plain sight; the source of every case: YouEDC Capture, by hand, external YouEDC Safety
- Case completeness by ICH E2D, duplicate check, follow-up requests to the site YouEDC Safety
- Indicators: 7/15-day compliance, processing medians, sources and most frequent events YouEDC Safety
- Electronic submission to the authorities (manual for now) YouEDC Safety
In progress
YouEDC Sites: the master file
The trial and site master file: what is filed, what is missing, what was asked of the doctor.
1 of 3 done
- Trial Master File (eTMF, prototype): TMF Reference Model zones, versions, quality control, site pages and document requests, expiry reminders, go-live and lock records, YouEDC Capture data in the site copies YouEDC Sites
- Investigator dossiers: CV, GCP, licences and their expiry, one for all studies YouEDC Sites
- Site profile: equipment, laboratories, normal ranges, study history YouEDC Sites
Later
Later
What we build next, and what is needed before work with real patients.
- Metrics across studies: entry lag, cleaning progress YouEDC Studio
- Work with real patients: personal data operator, notice to the regulator, validated installation Portal
- Local AI assistants with no data leaving the server Portal
- Installations for Israel, the USA and Germany Portal
Have an idea for YouEDC? Write to contact@youedc.com.