SERVICE AREAS

Eight disciplines. One Single Point of Contact.

Strategy, regulatory, project management, monitoring, data, biostatistics, pharmacovigilance, medical writing — all in-house, all senior, all on the same team behind one accountable Project Manager.

SERVICE ·01

Study Concept

The foundation of every successful trial.

A successful clinical study begins long before the first patient is enrolled. Strategic goals must be translated into research questions. A rigorous study concept defines the scientific and regulatory pathway, determines feasibility, and shapes timeline and budget for everything that follows.

01

Research Question & Feasibility

D-A-CH patient potential, recruitment assessment, sector-specific feasibility — before a single euro is committed.

02

Study Design

RCT, pragmatic, observational, or hybrid — optimised for your indication and regulatory pathway.

03

Statistical Analysis Plan

Biostatisticians integrated early to build a robust SAP before a single data point is collected.

04

Regulatory Strategy

Full pathway mapped for BfArM, EMA, FDA or Ethics Committees from day one.

What you can expect
  • A concept scientifically sound and operationally feasible — submission-ready from day one.
  • An interdisciplinary team: clinicians, biostatisticians, PM, RA, market access specialists.
  • Translation of your research question into a publication-ready concept.
  • A clear regulatory roadmap before submission — not after.
  • Strategy→ Concept
  • D-A-CHfeasibility
  • ICH E9from day one
  • Oneteam
SERVICE ·02

Regulatory & Ethics

BfArM · PEI · EMA · FDA — fluent in every dialect.

Full-spectrum regulatory services. From early strategic planning and scientific advice through protocol development, Clinical Trial Application filing, Ethics Committee submissions, and IMPD preparation — to legal representation. Every document, every submission, every deadline. Delivered together with Athagoras Group’s regulatory experts, ensuring no regulatory detail is overlooked.

01

Scientific Advice

BfArM, PEI, EMA and FDA scientific advice preparation and protocol assistance.

02

CTA Filing

Clinical Trial Application across the EU CTR framework and beyond.

03

Ethics Committees

Ethics committee submissions across all relevant D-A-CH and EU jurisdictions.

04

IMPD & Roadmap

IMPD preparation and continuous regulatory roadmap development through the lifecycle.

What you can expect
  • Submissions formatted once — accepted by every authority in scope.
  • A live regulatory roadmap that adapts to feedback rather than collapsing under it.
  • BfArM and PEI dialogue handled in German, by people who know the inspectors.
  • No retrofitting. Strategy first, file second.
  • BfArMPEI · EMA · FDA
  • EU CTRready
  • MDRIVDR · GVP
  • Oncesubmitted
SERVICE ·03

Project Management

Single Point of Contact. No fragmentation. No delays.

Conducting a clinical trial requires a partner who is fully committed to your project, has in-depth knowledge of the German regulatory landscape and is firmly established in the region where your trial is being conducted. The SPOC model: a dedicated project manager serving as your central point of contact for trial sites, service providers, regulatory authorities, and your internal team.

01

Study Planning & Feasibility

Timeline, budget and risk planning — built from scratch around your indication, sites and team.

02

Regulatory & Ethics Liaison

BfArM and PEI liaison handled by the same person who runs your project — not a separate inbox.

03

Vendor & Site Management

D-A-CH vendors and sites managed through one accountable contact, end-to-end.

04

Risk & Quality Oversight

Continuous risk register, quality oversight, and audit-readiness — from Phase II to final CSR.

What you can expect
  • One dedicated PM as the single accountable counterpart.
  • Flat hierarchies — the right person is always reachable.
  • From kick-off to close-out — high quality across every project and study.
  • Decisions made fast. No 14-day approval loops.
  • 1Project Manager
  • SPOCmodel
  • Phase II→ CSR
  • Flathierarchies
SERVICE ·04

Monitoring

Hybrid and fit-for-purpose, per ICH-GCP E6(R3).

Effective clinical monitoring is the cornerstone of data integrity and patient safety. At CSG, monitoring is an active, expert-led quality instrument — consistently managing every step of your study from first contact through to close-out visit.

01

Fit-for-purpose & Hybrid

On-site SDV, remote EDC review and Risk-Based Monitoring blended into one cohesive strategy.

02

SDV & Plausibility

Source Data Verification and plausibility checks calibrated to the risks that actually matter to your endpoints.

03

IP Accountability

Investigational product accountability — drug, device, biologic — handled to ICH-GCP standard.

04

D-A-CH CRA Network

CRAs who speak the local language, understand German hospital workflows, and are on-site rapidly.

What you can expect
  • Sites that are audit-ready at all times — not just before an inspection.
  • Low CRA turnover. Stable investigator relationships. Higher data quality.
  • Inspection and audit coaching included by default.
  • ICH-GCP E6(R3) hybrid monitoring with effort focused where risk is highest.
  • ICH-GCPE6(R3)
  • D-A-CHCRA network
  • HybridSDV + RBM
  • Auditready
SERVICE ·05

Data Management

Full pipeline. Zero compromise.

In clinical research, data is your most valuable asset. We manage the full data pipeline — from first patient entry to submission-ready delivery — with precision, compliance, and flexibility.

01

RDC & Collection

Remote Data Capture via Oracle Clinical RDC and other validated platforms; hybrid paper/electronic supported.

02

ePRO & eDiary

Integrated patient-reported outcomes — particularly valuable for RWE, registries and long-term observational programmes.

03

External Integration

CRF data consolidated with lab results, DICOM imaging, and diagnostics into a single clean data repository.

04

CDISC Delivery

CDISC-compliant SDTM datasets — submission-ready for BfArM, EMA or FDA.

What you can expect
  • A locked database — CDISC-compliant, submission-ready.
  • GAMP 5, FDA 21 CFR Part 11, EU Annex 11, EMA/INS/GCP/112288/2023 and GDPR/DSGVO compliant.
  • Fast database closure via SPOC collaboration between DM, Stats and Clinical Operations.
  • Tailored collection — pure electronic, hybrid, or registry-grade.
  • OracleClinical RDC
  • CDISCSDTM
  • 21 CFRPart 11
  • GAMP5
SERVICE ·06

Biostatistics

Built in early — not bolted on late.

Statistical considerations built in late are costly to fix. Built in early, they define the quality of your evidence. At CSG, biostatistics is the strategic core of your study — not a final step.

01

Sample Size & Power

Sample size, statistical power and randomisation schedules — from the first protocol discussion.

02

Statistical Analysis Plan

Pre-specified endpoints, methodology, missing-data strategy, subgroup and sensitivity analyses — ICH E9 compliant.

03

SAS® Programming

Validated, reproducible outputs — CDISC-compliant ADaM and SDTM datasets generated in SAS®.

04

TLFs

Tables, Listings and Figures for your Clinical Study Report — on time, audit-proof, submission-ready.

What you can expect
  • A comprehensive SAP delivered before database lock.
  • Methodology pre-specified — no post-hoc surprises.
  • TLFs validated and reproducible — every analysis re-runnable.
  • Statistical strategy aligned with your regulatory pathway.
  • ICH E9compliant
  • SAS®validated
  • CDISCADaM · SDTM
  • Prespecified
SERVICE ·07

Pharmacovigilance

PSUR · PBRER · DSUR. QPPV in-house.

Safety surveillance from first dose through patent expiry. SAE management, SUSAR reporting, RMP creation and updates, signal detection, DSMB participation — and materiovigilance for MedTech.

01

SAE & SUSAR

SAE management and SUSAR reporting in line with EU PV legislation and Volume 9A.

02

Periodic Reports

PSUR / PBRER / DSUR authored and submitted on time — every cycle.

03

RMP & Signals

Risk Management Plan creation and updates; continuous signal detection across your portfolio.

04

QPPV

QPPV coverage in-house. PV Scientists, DSMB participation, and materiovigilance for MedTech (PMCF · PMS · FSCAs · PRRC under MDR).

What you can expect
  • Every signal noticed, every report on time, every regulator quietly satisfied.
  • QPPV oversight and continuous availability — no outsourced gaps.
  • GVP-compliant PV agreements and database access from day one.
  • Materiovigilance for MedTech aligned with MDR and ISO 14971.
  • QPPVin-house
  • GVPcompliant
  • PSURPBRER · DSUR
  • Lifecyclehorizon
SERVICE ·08

Medical Writing

Documents written once. Accepted everywhere.

Medical writing is the connective tissue of clinical research — protocols, brochures, CSRs, IMPDs, regulatory dossiers. Authored by writers who have submitted to the authorities you’ll meet.

01

Protocol & IB

Comprehensive Protocol Writing, Investigator Brochures and Case Report Forms to EMA/BfArM/FDA standard.

02

Patient Materials

Patient Information and Consent Forms across multiple jurisdictions and reading levels.

03

CSR & IMPD

Clinical Study Reports and IMPD documentation — pre-submission and inspection-ready.

04

Regulatory Dossiers

Regulatory dossier authoring and review across CTD modules for marketing authorisation and lifecycle.

What you can expect
  • Medical writing aligned with statistics and data management — no version drift.
  • Documents authored to EMA, BfArM and FDA standards simultaneously.
  • Senior writers, not delegated to junior staff under deadline pressure.
  • Editorial review baked into the timeline — not bolted on.
  • EMABfArM · FDA
  • CTDready
  • Seniorauthors
  • Onesource of truth