ctms. | Tesserblu

/ CDMS

Clinical Trial Management System

Orchestrate every study phase — from first site to database lock.

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.

Key capabilities

Protocol & Study Setup

Site Identification & Activation

Participant Tracking

Milestone Monitoring

IMP & Supply Integration

Regulatory & Safety Coordination

47

Active studies

312

Sites managed

18,400

Participants enrolled

94%

Milestone on-time rate

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 Protocol & Study Setup

Version-controlled protocol repository with amendment tracking. AI-powered amendment impact analysis propagates changes to site documentation and CRF specifications automatically.

02 Site Identification & Activation

Feasibility questionnaires, site scoring, regulatory submission tracking and site initiation visit checklists — all in one view per country and site.

03 Participant Tracking

End-to-end subject lifecycle from pre-screening through completion or withdrawal, with enrolment projections vs plan and screen-failure analytics.

04 Milestone Monitoring

Configurable milestone templates per phase. AI burn-down analysis predicts at-risk deliverables up to 8 weeks ahead and proposes corrective actions.

05 IMP & Supply Integration

Real-time inventory view per depot and site, reconciled with Salvus RTSM/IRT. Expiry alerts, resupply triggers and accountability summaries.

06 Regulatory & Safety Coordination

Submission tracker (IRB/IEC, HA) with deadline management. Seamless SAE handoff to Salvus ICSR for expedited reporting workflows.

07 Budget & Contract Management

Site contract lifecycle, payment milestones and cost-per-subject analysis across the portfolio with variance tracking.

08 Analytics & Oversight

Real-time dashboards for executive, sponsor and site views. Exportable listing packages for TMF reconciliation and inspection readiness.

How it works

From day one to every day after.

A typical journey through Clinical Trial Management System — from onboarding to steady-state operations.

1

2

3

4 Protocol ready

Load the approved protocol; AI extracts the schedule of assessments, visit windows and endpoint definitions into a draft study plan for sponsor review.

Sites activated

Run feasibility scoring, track regulatory submissions and site initiation — milestones auto-flag when any critical-path item falls behind.

Trial executed

Enrolment, visit compliance, deviation capture and supply reconciliation run in real time. At-risk signals surface in the ops dashboard before they become issues.

Study closed

Data lock, regulatory submission coordination and TMF reconciliation are tracked to completion — with one-click audit-ready export for inspections.

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 Clinical Trial Management System 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.

Clinical Trial Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

/ CDMS

Clinical Trial Management System

Orchestrate every study phase — from first site to database lock.

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.

Key capabilities

Protocol & Study Setup

Site Identification & Activation

Participant Tracking

Milestone Monitoring

IMP & Supply Integration

Regulatory & Safety Coordination

47

Active studies

312

Sites managed

18,400

Participants enrolled

94%

Milestone on-time rate

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

Protocol & Study Setup

Version-controlled protocol repository with amendment tracking. AI-powered amendment impact analysis propagates changes to site documentation and CRF specifications automatically.

02

Site Identification & Activation

Feasibility questionnaires, site scoring, regulatory submission tracking and site initiation visit checklists — all in one view per country and site.

03

Participant Tracking

End-to-end subject lifecycle from pre-screening through completion or withdrawal, with enrolment projections vs plan and screen-failure analytics.

04

Milestone Monitoring

Configurable milestone templates per phase. AI burn-down analysis predicts at-risk deliverables up to 8 weeks ahead and proposes corrective actions.

05

IMP & Supply Integration

Real-time inventory view per depot and site, reconciled with Salvus RTSM/IRT. Expiry alerts, resupply triggers and accountability summaries.

06

Regulatory & Safety Coordination

Submission tracker (IRB/IEC, HA) with deadline management. Seamless SAE handoff to Salvus ICSR for expedited reporting workflows.

07

Budget & Contract Management

Site contract lifecycle, payment milestones and cost-per-subject analysis across the portfolio with variance tracking.

08

Analytics & Oversight

Real-time dashboards for executive, sponsor and site views. Exportable listing packages for TMF reconciliation and inspection readiness.

How it works

From day one to every day after.

A typical journey through Clinical Trial Management System — from onboarding to steady-state operations.

1

2

3

4

Protocol ready

Load the approved protocol; AI extracts the schedule of assessments, visit windows and endpoint definitions into a draft study plan for sponsor review.

Sites activated

Run feasibility scoring, track regulatory submissions and site initiation — milestones auto-flag when any critical-path item falls behind.

Trial executed

Enrolment, visit compliance, deviation capture and supply reconciliation run in real time. At-risk signals surface in the ops dashboard before they become issues.

Study closed

Data lock, regulatory submission coordination and TMF reconciliation are tracked to completion — with one-click audit-ready export for inspections.

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.

Clinical Trial Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

RTSM / IRT

Supply chain & randomization events

EDC

Visit data & eCRF completion status

CDMS

Data management & database lock

ICSR

SAE reporting & safety oversight

Compliant with

ICH E6(R3) GCP

21 CFR Part 11