SECTORS / 7 VERTICALS

Where evidence
meets market.

Pharma, MedTech, Digital Health, ATMP, Real-World Evidence, plus the two G-BA-driven evidence pathways — AbD (§35a) and Erprobungsstudien (§137e). Seven sectors, seven regulatory languages. We speak them all.

SECTOR01 / PHARMA · BIOTECH

Phase II–IV with submission discipline built in.

Pre-Approval · Post-Approval · AbD §35a SGB V
Phase IIPhase IIIPhase IVNISPASSAbDRegistry

Pre-approval. Phase II and III studies via secure Clinical EDC, full pharmacovigilance coverage — SAE, SUSAR, RMP, DSMB — and patient recruitment powered by IMC clinicon site analytics.

Post-approval. Observational studies (incl. NIS), Pragmatic Trials, PASS, and Phase IV / Phase IIIb studies supporting label and indication expansion. Registry setup and enhancement of existing registries through ongoing monitoring and data quality improvement.

AbD §35a SGB V. Operational partner for protocols and SAPs from IGES specialists or your evaluators. Pragmatic monitoring, high data quality, timely registry data exports — at agreed G-BA reporting dates.

SCOPE
Pharmaceuticals · Biotech

Small molecules, biologics, biosimilars — across the lifecycle.

EVIDENCE
HTA-ready data

From RCT to registry — built to convince G-BA, IQWiG, and the EU CTR.

SECTOR02 / MEDTECH

From CE-mark to reimbursement, in one motion.

Pre-Launch · Post-Launch · §137e
MDRIVDRCE-markPMCFPMS§137eMateriovigilance

Pre-launch. MDR- and IVDR-compliant clinical investigations and performance studies — including pivotal studies for CE marking. Device-specific designs and endpoints, patient recruitment, and medical writing, enriched by Athagoras’ deep market access know-how across Europe.

Post-launch. PMCF studies, observational and registry-based studies, PMS, materiovigilance, and risk management aligned to ISO 14971 — generating evidence for sustained market access and positioning across Europe.

G-BA §137e — Erprobungsstudien. Your gateway to standard GKV reimbursement: feasible protocols, HTA-authority dialogue, and efficient study management. CSG brings hands-on experience from two such projects.

SUPPORT
Hospital site assessments

Backed by IMC clinicon — feasibility and site identification grounded in real D-A-CH data.

FRAMEWORK
MDR · IVDR · ISO 14971

Compliance is the floor. Strategic positioning across Europe is the ceiling.

SECTOR03 / DIGITAL HEALTH

From first evidence to permanent listing.

DiGA · §139e SGB V · BfArM Fast-Track
BfArM Fast-TrackPos. VersorgungseffektRCTpragmaticePROeDiaryNIS

One of the first. CSG is one of the first CROs in Germany to specialise in clinical trials for Digital Health Applications — guiding manufacturers through the full BfArM Fast-Track lifecycle under §139e SGB V.

Clinical evidence. GCP-compliant RCT or pragmatic trials proving the “positiver Versorgungseffekt” — supported by PRO, ePRO and eDiary expertise.

Listing and beyond. Dossier preparation and endpoint strategy aligned with BfArM — developed with Athagoras Group experts — covering the bridge from provisional to permanent listing, as well as the RWE required for annual re-listing via NIS, continuous ePRO follow-up, and G-BA-ready reporting.

CLINICAL
Versorgungseffekt

The primary BfArM prerequisite — designed and proven, not just declared.

POST-LISTING
Annual re-listing

Routine-care RWE that protects your DiGA-Verzeichnis listing long-term.

SECTOR04 / ATMP

Gene, cell, tissue — research at its frontier.

Gene Therapy · Cell Therapy · CAR-T
Gene TherapyCAR-TCell & TissueEMALong-term follow-up

A new frontier. Advanced Therapy Medicinal Products — gene therapies, CAR-T, cell and tissue therapies. Complex biology, patient-specific manufacturing, and long-term safety monitoring demand a partner who has done it before.

Specialised expertise. ATMP trials require knowledge well beyond traditional pharmaceutical approaches. Dynamic regulatory landscapes, unique study designs, and meticulous long-term oversight — navigated with the regulatory and European market access expertise of Athagoras Group partners. Full lifecycle. Demonstrable ATMP experience — from early feasibility and dose-escalation through to post-marketing observation. EMA-aligned, drawing on Athagoras partners’ regulatory strategy for viral vectors and gene constructs, plus the long-term follow-up these therapies require.

PHASES
Early Dev → PMS

Feasibility, dose-escalation, Phase II/III, and post-approval observation under one team.

COVERAGE
End-to-end

PM, DM, biostatistics, pharmacovigilance — single-partner Full-Service support.

SECTOR05 / REAL-WORLD EVIDENCE

When approval is the beginning — not the end.

NIS · PASS · PMS · Registries · AbD · §137e
NISPASSPMSRegistrySmartCareAbD§137eePRO

Primary & secondary data. Non-Interventional Studies, PASS, and Post-Marketing Surveillance — capturing the true effectiveness and safety of your product under real-world conditions. Prospective and retrospective designs, chart reviews, ePRO and eDiary — complemented by the secondary data and database analytics expertise of the Athagoras Group.

Networks in routine care. Relationships with physicians, clinics and providers across D-A-CH that get you the patients and data sources your study actually needs — in real care, not just trial settings.

Registries and pragmatic trials. Proven registry experience built through ABD — with qualified monitoring and SDV, randomisation in routine care, and the discipline to keep HTA-relevant data clean and audit-ready.

FRAMEWORKS
AbD §35a · §137h · §137e

The German HTA stack — handled by people who built the playbook.

SCALE
1 to 90 sites

From single-centre registries to nationwide programmes.

SECTOR06 / ABD

Post-marketing evidence with HTA-grade discipline.

AbD · §35a SGB V · G-BA · IQWiG
AbD§35aG-BAIQWiGRegistrySDVHTA

When the G-BA mandates evidence — the stakes are high. Following market launch, the G-BA may order post-marketing data collection (AbD) under §35a SGB V for drugs and orphan drugs where costs are high and evidence is deemed insufficient. Data is typically collected through registries, with Source Data Verification required.

Monitoring with a delicate touch. Registry data in daily practice already demands additional effort and discipline. Add HTA scrutiny and on-site monitoring visits, and the workload reaches its limit — making experienced monitors who can distinguish RWD from clinical trial data essential.

What makes it work. Protocol adaptations and SAP requirements aligned to G-BA / IQWiG guidelines — translated into practice through experienced monitoring. Site fatigue actively managed, data gaps minimised from the outset, and first-class communication across all stakeholders — sites, sponsors, and regulatory interfaces — as the decisive success factor in the German statutory health insurance market.

FRAMEWORK
§35a SGB V

G-BA-mandated post-marketing data collection — the AbD procedure end-to-end.

PARTNERSHIP
IGES · IQWiG

Protocols and SAPs from IGES specialists or your evaluators — we operationalise.

SECTOR07 / ERPROBUNGSSTUDIEN

The gateway to standard GKV reimbursement for MedTech.

§137e SGB V · Pilot Studies · G-BA
§137eG-BA PilotGKVMedTechReimbursementHTA

A decisive path to reimbursement. For medical devices, the G-BA pilot study under §137e SGB V is a viable route to GKV reimbursement — provided the method or product has shown its value in clinical practice, evidence is still pending, and “potential” has been recognised by the G-BA.

A sound approach if you know what you’re up against. The study may be initiated by the manufacturer or by the G-BA itself. Success rests on well-designed protocols meeting HTA agency requirements, and a robust network of sites prepared — infrastructurally — to deliver the method and meet recruitment goals.

Proven track record. With two G-BA-commissioned studies under §137e already delivered, CSG combines startup flexibility with deep experience in these specialised studies — from early planning through to the final study report.

PROOF
2 G-BA-commissioned

Two completed §137e studies on behalf of the G-BA — not theory, evidence.

SCOPE
Planning → Final Report

End-to-end support — protocol, dialogue with HTA, study conduct, final report.

Tell us which sector,
we'll tell you the path.

Lots of engagements start with a 30-minute call. By the end of it you'll have a feasibility view, a regulatory roadmap, and a named PM.

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