CTMS for Investigator-Initiated Studies

Still managing IIS in Excel and SharePoint?

A lightweight, SOP-tailorable study management tool for small and mid-size medtech — without the cost and complexity of enterprise CTMS platforms.

Try the live demo

Explore a fully working environment filled with mock data — studies, sites, documents, budgets, and milestones. Leave your work email and you're in.

Everything an IIS program needs — nothing it doesn't

From first proposal to final publication: one tool, tailored to your SOPs.

Structured study register

Every IIS in one place: status, sites, investigators, and milestones — not scattered across five spreadsheets.

Portfolio dashboard

KPIs, an interactive country map, and an attention panel that flags overdue milestones and missing documents.

Document tracking

Completeness checked per study against your SOP requirements — audit preparation without inbox archaeology.

Budgets, contracts & communications

Milestone payments, spend versus budget, and the relevant correspondence — linked to each study.

One-click reporting

Export a branded portfolio report or CSV for management and stakeholders — no copy-paste slide decks.

Custom onboarding

Existing Excel masters get migrated, and checklists and workflows configured to existing SOPs — live in weeks, not quarters.

Sponsor-side data only

No patient data, no CRFs — GDPR-compliant by design and free of EDC-grade validation burden.

EU data hosting

Operated on secure servers in Germany — your study data never leaves the EU.

Audit trail (ALCOA+)Not in demo

Who changed what, when, and why — append-only records with inspection-ready export.

IIS submission portalNot in demo

Investigators submit proposals online; you triage and track them in one pipeline instead of an inbox.

Role managementNot in demo

Granular permissions — from administrator and contributor to read-only auditor access.

Review processNot in demo

Structured review rounds and documented decisions, from intake to approval.

Features marked “not in demo” are on the active roadmap — ask about timelines in a walkthrough.

Tailored to your SOPs, not the other way around

The CTMS is deployed as a custom installation configured to your document requirements, workflows, and naming conventions — typically up and running in weeks, not quarters.

Questions? Call +49 1515 79 43 500 or write to marc.harms@mh-analytics.eu.