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.

SECTOR 01 / 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, NIS, feasibility, PASS, and Phase IV for indication expansion. Registry setup or improvement of existing registries via monitoring and the IGES data-management team.

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.

Pre-launch. MDR- and IVDR-compliant clinical investigations and performance studies — including pivotal studies for CE marking. Device-specific designs and endpoints, patient recruitment, materiovigilance, and medical writing.

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

G-BA §137e — Erprobungsstudien. Your gateway to standard GKV reimbursement: feasible protocols, HTA-authority dialogue, and efficient study management. CSG has run two G-BA-commissioned §137e studies.

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.

SECTOR 02 / MEDTECH

From CE-mark to reimbursement, in one motion.

Pre-Launch · Post-Launch · §137e
MDRIVDRCE-markPMCFPMS§137eMateriovigilance
SECTOR 03 / 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, endpoint strategy aligned with BfArM, the bridge from provisional listing (12 months) to permanent listing, plus the RWE needed 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.

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.

Full lifecycle. Demonstrable ATMP experience — from early feasibility and dose-escalation through to post-marketing observation. EMA-aligned, with logistics for living cells and viral vectors handled, 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.

SECTOR 04 / ATMP

Gene, cell, tissue — research at its frontier.

Gene Therapy · Cell Therapy · CAR-T
Gene TherapyCAR-TCell & TissueEMALong-term follow-up
SECTOR 05 / 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.

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. Qualified monitoring with SDV for registries; randomisation in routine care meeting §137e evidence requirements; and the discipline to keep HTA-relevant data clean.

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.

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.

Four core services. Protocols and SAPs adapted to G-BA / IQWiG guidelines; healthcare providers trained to minimise data gaps from the outset; specialised eCRF systems for real-world data; and integrity monitoring — securing your product's position 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.

SECTOR 06 / AbD

Post-marketing evidence with HTA-grade discipline.

AbD · §35a SGB V · G-BA · IQWiG
AbD§35aG-BAIQWiGRegistrySDVHTA
SECTOR 07 / 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.

Most 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.

Start the conversation →