Skip to main content

VIEW OUR UPCOMING VIRTUAL & IN-PERSON EVENTS

Study Start-Up: Faster Activations, Stronger Compliance

Study Start-Up centralizes every activation task, document, submission and stakeholder workflow into one connected, audit-ready environment. Purpose-built for global SSU teams, it reduces cycle times, eliminates rework, supports CTIS compliance and integrates seamlessly with Trial Interactive eTMF to keep your studies inspection-ready from day one.

SSU demo

What Study Start-Up Is & How It Helps

Investigative document

Study Start-Up is a configurable, end-to-end activation platform built to replace manual trackers and scattered communication with a single orchestrated workspace. It enables sponsors, CROs and SSU leads to manage country- and site-level tasks, documents, submissions, approvals and timelines with real-time clarity across all regions, including full support for EU CTR and CTIS-specific workflows.

By connecting activation workflows directly with Trial Interactive eTMF, Country Overview and configurable automations, SSU teams reduce operational friction, standardize execution globally and avoid the typical downstream delays that surface during audit and inspection. The result: faster site activation, fewer handoffs, tighter compliance and confidence that every milestone is delivered with precision.

Core Capabilities That Drive Results

Country & Site Activation Control 


Configure global-to-local workflows, assign responsibilities, and standardize activation packages across all countries and sites. 

Submission & Approval Tracking 


Track submission progress, regulatory milestones, and approvals per Member State, including RMS proposal/confirmation in CTIS. 

Document Collection & Automation 


Centralize document requests, updates, and approvals with real-time status visibility and automated notifications. 

CTIS Region Support 


Pre-defined EU/EEA setup, CTIS attributes, and a dedicated tab for managing CTIS-specific data, statuses, and actions. 

Query Management 


Raise, track, and resolve queries directly on submitted documents with full audit history, entirely within Trial Interactive. 

Audit-Ready Oversight 


Every activity, document, query, and submission is captured with complete audit trails and role-based access controls. 

Essential Features of Study Start-Up

Purpose-Built SSU Execution

- Configurable study, country, and site activation workflows
- Country Overview with real-time statuses, packages, and dependencies
- Pre-defined global templates + regional variations (EU CTR, CTIS)
- Automated notifications and task handoffs
- Integrated document management and version control

Compliance & Quality by Design

- Full CTIS Region support: RMS assignment, MSC coordination, submission tracking
- Query Management for document clarification and updates
- Complete audit trails for all queries, submissions, and document interactions
- Access controls aligned with ICH E6(R3) and 21 CFR Part 11
- Secure integration with TI eTMF and platform-wide identity management (SSO/SAML/OIDC)

Connected Workflows That Reduce Time to Activation

- Direct integration with eTMF for filing readiness
- End-to-end visibility across sites, submissions, and timelines
- Fewer handoffs and less rework through standardized processes
- Faster country and site package completion
- Configurable reports and dashboards for cycle-time, completeness and blockage analysis

Smarter Country Workflows for Faster Activation

Trial Interactive's Study Start-Up now includes suggested, out-of-the-box country workflow templates covering 74 countries, built on current, in-force legislation and ready to deploy the moment a study is set up. Each template reflects the actual regulatory sequencing required in that market, so teams no longer need to map submission order manually for every country in a study. Workflows can also be adapted to fit each study's specific needs, giving teams a compliant, accurate starting point without locking them into a rigid process. The result is faster, more confident site activation across even the most complex multi-country trials.

Want to see how activation accelerates when everything is connected?

Request a demo and explore Trial Interactive Study Start-Up.

Request a demo and explore Trial Interactive Study Start-Up.

Contact Us

Solutions
Solutions
Solutions
Solutions

By submitting this form, you agree to the privacy policy.