Platform
Study Start-Up
Run feasibility, site selection, document collection, and activation as one connected workflow, with unified feasibility, configurable start-up forms, and every document landing straight in the eTMF.
Why it's different
Start-up on one connected record
The work that usually spans a feasibility tool, a stack of spreadsheets, and a separate eTMF happens in one place, configurable to your process and connected end to end.
Unified feasibility
Feasibility and site selection run on the same record as the rest of start-up, no re-keying between a separate feasibility tool and your operational systems.
Configurable start-up forms
Configure forms for every start-up activity, from site selection through initiation, instead of bending your process to fixed templates.
Seamless eTMF connection
Documents collected during start-up file themselves into the correct eTMF and ISF structure automatically, no separate upload, no reconciliation.
Document Packs
Define, assign, and collect, without the spreadsheet
Document Packs give start-up a controlled way to define what each site must provide, request it, and collect it, with all the tracking in FICS instead of email and Excel.
- Reusable document packs. Define standard packs of required documents once in the library, then reuse and adapt them study to study.
- Targeted assignment & bulk requests. Assign packs to every site, to selected countries, or to a single site, and send document requests in bulk or site by site.
- Upload, sign, and auto-file. Sites upload documents or e-sign in FICS; responses file straight into the ISF and TMF for sponsor review.
- Collection dashboards. Track collection progress across sites and countries at a glance, replacing the start-up tracking spreadsheet.
Site Greenlight
One view of site readiness, from request to activation
Greenlight brings every start-up requirement for a site into a single view, so teams can see what's outstanding, close the gaps, and approve sites to begin enrolling.
- One view of every requirement. A single, per-site view of all Greenlight requirements, documents, milestones, and forms, instead of hunting across the system.
- Progress you can see. Progress bars and clear visuals show sites exactly what's outstanding, with tasks, comments, and reminders in one place.
- Status across the study. Dashboards roll up Greenlight status by site, country, and study so trial managers can act on what's most pressing.
- Review and activate. Once every expected document is filed and approved, reviewers approve the site's Greenlight, completing the milestone and clearing it to enroll.
Activate sites faster, on one record.
See how FICS runs feasibility, document collection, and Greenlight in one connected start-up workflow.