Data that holds.
Evidence that moves the marker.
We build the arc of evidence.
A Berlin-based Full-Service CRO embedded within the 500+ expert network of the athagoras group. Ten stages, one continuous curve. From your first idea to the moment a regulator says yes and a patient gets better.
The foundation of every successful trial.
Strategic goals translated into research questions. A rigorous concept that defines the scientific and regulatory pathway, determines feasibility, and shapes timeline and budget for everything that follows.
Protocol writing in accordance with EMA and BfArM standards.
Comprehensive protocol, patient information and consent forms, Investigator Brochure, Case Report Forms, IMPD documentation. Medical writing prepared for every reviewer your study will encounter.
BfArM · PEI · EMA
Scientific advice and protocol assistance, Clinical Trial Application filing, and Ethics Committee submissions. Regulatory roadmap mapped from the start, not retrofitted.
Clear insight into the hospital landscape.
Feasibility analysis and site identification drawing on our network's site analytics, realistic recruitment timeline estimation, and competitive landscape intelligence. All backed by our D-A-CH CRA network.
Single Point of Contact. Fast-Decision Making.
Our Single Point of Contact (SPOC) model means one dedicated Project Manager serves as your central hub for all study activities, and your first point of contact as sponsor. From your initial briefing through to delivery, one person coordinates all study activities across study sites, service providers, regulatory authorities, and your internal team. Our flat hierarchies streamline bureaucratic processes and lead to quick decisions.
Expert-Led Monitoring. End-to-End.
On-site Source Data Verification, remote EDC review, and Risk-Based Monitoring blended into one strategy. Maximum oversight, optimised resources: effort focused on the risks that actually matter to your endpoints.
Full pipeline. Zero compromise.
From first patient entry to submission-ready delivery: Remote Data Capture via Oracle Clinical RDC, hybrid CRF approaches, integrated ePRO and eDiary, GAMP 5 / 21 CFR Part 11 / Annex 11 / EMA/INS/GCP/112288/2023 / GDPR compliant.
Biostatistics You Can Build On.
CSG Biostatistics delivers validated, CDISC-compliant statistical analyses and programming in SAS® or R, covering everything from study design and SAP authoring to regulatory submission support, tailored to your research objectives.
Full vigilance. Zero blind spots.
SAE management, SUSAR reporting, RMP creation and updates, signal detection, DSMB participation. Materiovigilance for MedTech.
When market approval is the beginning.
NIS, PASS, PAES, PMS, label updates. RWE strategy, registries, AbD (§35a SGB V), Erprobungsstudien (§137e SGB V). Health Care Research · Patient Preferences · Clinical Pathways.
Small enough to be agile.
Rooted deep enough to matter.
Large enough to handle anything.
Single Point of Contact
One dedicated PM for every project. No fragmentation, no delays.
Full-Service or FSP
Engagement tailored to your needs, from a single workstream to a whole study.
Regulatory Expertise
BfArM · PEI · EMA · FDA · G-BA · MDR: fluent in every dialect.
CRO Expertise
Phase II–IV · CE-Mark · §137e · DiGA · AbD · RWD: the full evidence stack.
Quality First
ICH-GCP E6(R3) · MDR · GDPR compliant
Ready to sketch
the arc of your trial?
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.
Start the conversation →