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.
CE Mark clinical investigations.
MDR- and IVDR-compliant clinical investigations and performance studies for medical devices and IVDs, including the pivotal studies that carry a CE marking. Device-specific designs and endpoints, from first-in-human through to proof of concept.
Device evidence has its own grammar. Clinical investigations under MDR Article 62 and performance studies under IVDR follow rules that differ from drug development at almost every step: from the risk classification that determines what evidence is needed at all, to the Notified Body review that decides whether it was enough.
We design device-specific endpoints and run the studies that carry a product from first-in-human and proof of concept through to the pivotal investigation behind the CE marking.
PMS: post-market surveillance.
Everything a product owes the market after approval: PMCF for devices, PASS and PAES for medicinal products, and the signal detection that ties them together. Run by a team that authors PSURs, not just deliverables. EudraVigilance and FDA gateways included.
Post-market surveillance is where a dossier meets routine care. For devices, PMCF keeps the clinical evidence current against the MDR’s ongoing obligations; for medicinal products, PASS and PAES answer the safety and efficacy questions a regulator attached to the approval.
All pharmacovigilance needs, covered within the athagoras group. Experienced teams and specialists who know the regulatory nuances: from signal detection and case processing to PSUR authoring and risk management. One integrated setup, no gaps.
Anwendungsbegleitende Datenerhebung, AbD 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.
AbD and DiGA studies are won or lost on the details: correctly interpreting G-BA and BfArM requirements, bringing the right sensitivity and patience to a collaborative regulatory process with both authorities, and deploying study budgets efficiently within that framework. Translating complex protocols into pragmatic site-level reality (without generating site fatigue) while maintaining full GCP compliance and the high data standards these studies demand.
Erprobungs- studie (§137e).
Method-evaluation studies for innovative procedures, run under the German G-BA framework. We have walked this path more often than most.
§137e SGB V Erprobungsstudien are the path to standard GKV reimbursement for innovative medical procedures. We know from experience what determines success: robust feasibility, reliable recruitment, and solid financing, the foundations that need to be right before the study begins.
Registries & real-world data.
Registry-based studies that follow a therapy through routine care, prospective and retrospective, with the long-term follow-up that surveillance obligations, reimbursement dossiers and health-services research all rely on. Also the data source behind AbD and Erprobungsstudien.
A registry is the only study design that keeps answering questions years after recruitment closes. That makes it the backbone of post-market evidence: the surveillance a regulator expects, the effectiveness data a payer asks for, and the routine-care picture that no controlled trial can produce on its own.
We build them as data infrastructure rather than one-off studies: from non-interventional designs, chart review and ePRO follow-up through to the secondary-data and database analytics expertise of the athagoras group.