Every kind
of trial — across
every phase.
From pre-launch confirmatory studies to post-approval surveillance, and digital-therapeutics and specific post-launch Studies ( Erprobungsstudien §137e SGBV, ABD §35a SGBV). Five families of studies, one team that has run them all.
One product. A lifecycle
of evidence.
A therapy doesn't stop generating questions when it gets approved. We run the studies that answer them — at every stage.
Pre-Launch Confirmatory trials.
Phase II/III studies designed to support a regulatory filing. Run with adaptive design, integrated biostatistics, and the regulatory team in the room from week one.
Post-Launch & Phase IV.
Label-expansion, long-term safety, effectiveness in routine care. Built to answer the questions a regulator will ask next year, not last.
Pharmaco- vigilance studies.
PASS, PAES, and signal-detection studies. Run by a PV team that authors PSURs, not just deliverables. EudraVigilance and FDA gateways included.
Erprobungs- studien (§137e).
Method-evaluation studies for innovative procedures, run under the German G-BA framework. We have walked this path more often than most.
Anwendungsbegleitende Datenerhebung — ABD & DiGA studies.
For digital therapeutics and orphan-drug populations, evidence is built differently. We run §35a/§35c ABD studies for AMNOG dossiers and DiGA evaluations for the BfArM directory — combining clinical, real-world and patient-reported endpoints with the agility a digital product cycle demands.
A few recent studies
we've run.
| Code | Therapeutic Area | Phase | Sites · Subj. | Sector | Status |
|---|---|---|---|---|---|
| CSG-241 | Cardiovascular · HF | III | 42 · 1,840 | Pharma | LIVE |
| CSG-238 | Oncology · NSCLC | II | 18 · 220 | Biotech | LIVE |
| CSG-235 | Digital · Type 2 Diabetes | DiGA | 12 · 480 | DiGA | LOCK |
| CSG-232 | Med Device · Cardiac Mon. | §137e | 22 · 600 | Med Tech | LIVE |
| CSG-227 | Neurology · MS | IV | 56 · 2,400 | Pharma | DONE |
| CSG-220 | Rare Disease · ABD | ABD | 8 · 130 | Biotech | DONE |