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CTMS Module 27 of 29

Startup Workflow

Study startup task orchestration from feasibility through site activation.

Module Overview

The Startup Workflow module orchestrates the complex study startup process from feasibility assessment through country regulatory submissions, site selection, contract negotiation, IRB approvals, and site activation. It provides a structured startup checklist with parallel and sequential tasks, dependency management, and critical path tracking to minimize time-to-activation.

Key Features

Structured startup checklist with task dependencies
Parallel and sequential task orchestration
Critical path identification and tracking
Startup timeline forecasting with bottleneck analysis
Country and site-level startup task tracking
Startup readiness scorecard

Workflow & Interface

Explore the module's workflow through interactive interface mockups showing each step of the process.

1

Startup Task Checklist

Comprehensive startup checklist with task status, assignee, dependencies, and critical path indicators.

medifirm-ctms — module view
TaskOwnerDependencyDurationStatus
Feasibility AssessmentClinical Ops2 weeks Complete
Country Regulatory StrategyRegulatoryFeasibility3 weeks Complete
Site SelectionClinical OpsFeasibility4 weeks Complete
CTA SubmissionRegulatoryCountry Strategy6 weeks
In Progress
Contract NegotiationLegalSite Selection8 weeks
In Progress
IRB SubmissionSite OpsCTA Approval4 weeks
Pending
2

Startup Pipeline

Track country and site startup progress through the activation pipeline.

medifirm-ctms — module view

USA — 5 sites

Contracts & IRB

75% complete

India — 3 sites

Regulatory submission

50% complete

Japan — 2 sites

Site selection

30% complete

Germany — 4 sites

Feasibility

15% complete

Sweden — 2 sites

Activated

100% complete
3

Startup Timeline & Forecast

Monitor startup timeline with projected activation dates and bottleneck identification.

medifirm-ctms — module view

Overall Startup

62%

On track

Countries Active

2/8

6 in progress

Sites Activated

8/42

19% activated

Projected Full Activation

Sep 30, 2024

+2 weeks vs plan

Module Connections

How Startup Workflow integrates with other CTMS modules in the platform.

BidirectionalCountry Activations

Country regulatory tasks in startup workflow

View Module
BidirectionalSite Management

Site activation is final startup step

View Module
BidirectionalConfigurable Workflows

Startup tasks use configurable workflows

View Module
BidirectionalMilestone Tracking

Startup milestones tracked

View Module
BidirectionalDocument Approvals

Contracts and regulatory docs need approval

View Module