edc. | Tesserblu

/ EDC

Electronic Data Capture

Site-facing data capture that sites actually want to use.

Salvus EDC combines a no-code form designer, a declarative edit-check engine with a built-in test harness, risk-based SDV and CDISC-standard exports — built so per-study validation is fast and site adoption is frictionless.

Key capabilities

eCRF Form Designer

Edit-Check Engine

Visit Schedule & Dynamics

Risk-Based SDV / SDR

Medical Coding

Mid-Study Amendments

< 8 wks

Build to go-live average

300+

Edit checks per study

96.9%

AI extraction precision

ODM 2.0

Export standard

What it does

All the capability, none of the complexity.

Salvus CTMS gives sponsors, CROs and sites a single operational truth across protocol management, site activation, participant tracking, milestone control, and regulatory submission coordination. AI-assisted planning flags at-risk milestones before they slip.

01 eCRF Form Designer

Drag-and-drop builder with CDASH v2.x alignment on every field. WYSIWYG site preview. Annotated CRF PDF with SDTM annotations generated automatically.

02 Edit-Check Engine

No-code rule builder for univariate, cross-field, cross-form and cross-visit checks. Built-in test harness — test results stored as validation evidence.

03 Visit Schedule & Dynamics

Visual schedule-of-assessments builder with visit windows, log forms and dynamic field/form behaviour. Oncology cycles supported.

04 Risk-Based SDV / SDR

Per-field critical-to-quality flagging drives targeted verification plans. Monitor workbench shows assigned sites, broken verifications and field-level marks.

05 Medical Coding

MedDRA and WHODrug coding inline in EDC with AI suggestions for non-exact verbatims. Coder adjudicates every non-exact code.

06 Mid-Study Amendments

Amendment workspace: branch live study, run automated impact analysis, dry-run on cloned production data, deploy with dual e-signature.

07 SAE Handoff & Reconciliation

SAE form data generates E2B(R3) payloads to Salvus ICSR or third-party databases. Reconciliation workspace surfaces discrepancies.

08 CDISC Export & Archival

ODM-XML v2.0 API for CDMS. SDTM mapping with Define-XML v2.1. Full-fidelity archival export at database lock with audit trail.

How it works

From day one to every day after.

A typical journey through Electronic Data Capture — from onboarding to steady-state operations.

1

2

3

4 Build & UAT

Design forms and rules in Dev; promote to UAT; run the test harness and simulate full patient journeys. Deploy with e-signature approval.

Site go-live

Sites complete training gate before accessing production. Offline-tolerant entry and task-first home screen make adoption fast.

Clean & monitor

Auto-queries fire on save; manual queries from DMs and monitors. Risk-based SDV plan reduces verification volume without increasing risk.

Lock & archive

DM + sponsor dual-signature lock. ODM archival export with audit trail included. Site investigator file copy generated per market requirements.

See It in Action

Watch Clinical Trial Management System in action.

A guided walkthrough of the key workflows — built for Clinical Trial teams who need to see it to believe it.

.

How to add your demo video

1. Upload the Electronic Data Capture demo to YouTube.

2. Copy the video ID from the URL — the part after watch?v=

3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"

4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.

5. Save & deploy — the play button handles the rest automatically.

Integrations

Connects where you need it to.

Electronic Data Capture is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

/ EDC

Electronic Data Capture

Site-facing data capture that sites actually want to use.

Salvus EDC combines a no-code form designer, a declarative edit-check engine with a built-in test harness, risk-based SDV and CDISC-standard exports — built so per-study validation is fast and site adoption is frictionless.

Key capabilities

eCRF Form Designer

Edit-Check Engine

Visit Schedule & Dynamics

Risk-Based SDV / SDR

Medical Coding

Mid-Study Amendments

< 8 wks

Build to go-live average

300+

Edit checks per study

96.9%

AI extraction precision

ODM 2.0

Export standard

What it does

All the capability, none of the complexity.

Salvus CTMS gives sponsors, CROs and sites a single operational truth across protocol management, site activation, participant tracking, milestone control, and regulatory submission coordination. AI-assisted planning flags at-risk milestones before they slip.

01

eCRF Form Designer

Drag-and-drop builder with CDASH v2.x alignment on every field. WYSIWYG site preview. Annotated CRF PDF with SDTM annotations generated automatically.

02

Edit-Check Engine

No-code rule builder for univariate, cross-field, cross-form and cross-visit checks. Built-in test harness — test results stored as validation evidence.

03

Visit Schedule & Dynamics

Visual schedule-of-assessments builder with visit windows, log forms and dynamic field/form behaviour. Oncology cycles supported.

04

Risk-Based SDV / SDR

Per-field critical-to-quality flagging drives targeted verification plans. Monitor workbench shows assigned sites, broken verifications and field-level marks.

05

Medical Coding

MedDRA and WHODrug coding inline in EDC with AI suggestions for non-exact verbatims. Coder adjudicates every non-exact code.

06

Mid-Study Amendments

Amendment workspace: branch live study, run automated impact analysis, dry-run on cloned production data, deploy with dual e-signature.

07

SAE Handoff & Reconciliation

SAE form data generates E2B(R3) payloads to Salvus ICSR or third-party databases. Reconciliation workspace surfaces discrepancies.

08

CDISC Export & Archival

ODM-XML v2.0 API for CDMS. SDTM mapping with Define-XML v2.1. Full-fidelity archival export at database lock with audit trail.

How it works

From day one to every day after.

A typical journey through Electronic Data Capture — from onboarding to steady-state operations.

1

2

3

4

Build & UAT

Design forms and rules in Dev; promote to UAT; run the test harness and simulate full patient journeys. Deploy with e-signature approval.

Site go-live

Sites complete training gate before accessing production. Offline-tolerant entry and task-first home screen make adoption fast.

Clean & monitor

Auto-queries fire on save; manual queries from DMs and monitors. Risk-based SDV plan reduces verification volume without increasing risk.

Lock & archive

DM + sponsor dual-signature lock. ODM archival export with audit trail included. Site investigator file copy generated per market requirements.

See It in Action

Watch Clinical Trial Management System in action.

A guided walkthrough of the key workflows — built for Clinical Trial teams who need to see it to believe it.

.

How to add your demo video

Integrations

Connects where you need it to.

Electronic Data Capture is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

CDMS

ODM incremental data feed

RTSM / IRT

Enrolment, randomization & dispensing

CTMS

Site management & enrolment metrics

ICSR

E2B(R3) SAE handoff

Compliant with

21 CFR Part 11

CDISC CDASH v2.x