We bend the
arc of evidence
toward approval.
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 to EMA, BfArM and FDA 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 · FDA — fluent in every dialect.
Scientific advice and protocol assistance, Clinical Trial Application filing, Ethics Committee submissions and IMPD preparation. Regulatory roadmap mapped from the start, not retrofitted.
IMC Clinicon analytics. Realistic timelines.
Feasibility analysis and site identification using IMC Clinicon site analytics, realistic recruitment timeline estimation, and competitive landscape intelligence — backed by our D-A-CH CRA network.
Single Point of Contact. No fragmentation. No delays.
The SPOC model — one dedicated Project Manager as your central hub for study sites, service providers, regulatory authorities, and your internal team. Flat hierarchies streamline bureaucratic processes. Decisions get made fast.
Hybrid and fit-for-purpose, per ICH-GCP E6(R3).
On-site Source Data Verification, remote EDC review, and Risk-Based Monitoring blended into one strategy. Maximum oversight, optimised resources — effort focused where risk is highest.
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.
Built in early — not bolted on late.
Biostatisticians from the first protocol discussion: sample size, power, randomisation, endpoints. A comprehensive SAP fully compliant with ICH E9 — pre-specified, audit-proof, submission-ready.
PSUR · PBRER · DSUR. QPPV in-house.
SAE management, SUSAR reporting, RMP creation and updates, signal detection, DSMB participation. Materiovigilance for MedTech (PMCF · PMS · FSCAs · PRRC under MDR).
When market approval is the beginning — not the end.
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.
Send a one-paragraph brief →