Clinical Data Management for Phase I–IV Clinical Trials
Freelance data management at the interface of CDM, EDC, clinical operations, project management, market access and IT — from protocol to the first eCRF draft and to final data handover.
Benno Jürgen Antoni
Principal Clinical Data Management & EDC Consultant
Senior Clinical Data Manager / Lead · DE · EN · RO
Services for your study
From protocol to the first eCRF draft and to final data handover —
tailored clinical data management for every phase.
Clinical Data Management
End-to-end data management for clinical trials — from study start-up to database lock, focused on quality, compliance and on-time delivery.
EDC & eCRF Design
User-friendly eCRF design in leading EDC systems, including logic checks, edit checks and a clean data structure.
Data Validation & Checks
Programming and review of validation rules. Early detection of inconsistencies, implausible values and missing data.
Query Management
Fast, precise and communicative query handling. Fewer follow-ups, cleaner data and happier sites.
DMP, DVP & Regulatory Documentation
Data Management Plans, Data Validation Plans, annotated CRFs, edit and plausibility checks — all built on SOP-based, inspection-ready processes.
CDISC Standards & Data Mapping
CDASH-conform data capture, SDTM and ADaM mapping and standard-compliant data structures for smooth submissions and statistical analysis.
SQL Data Extraction & Reporting
Custom clinical database reporting with Exasol SQL, Microsoft SQL Server, PostgreSQL, Azure SQL and Oracle — including the DTM SQL Query Reporter.
Compliance & Quality
Work aligned with ICH-GCP, GxP, 21 CFR Part 11 and ALCOA+ principles. Documented, traceable and audit-ready.
VBA, VB.net, SQL, Exasol-SQL, XHTML/CSS, JSON, Python, SAS
Custom scripts, macros, data extracts and reporting solutions to automate workflows and improve data quality across clinical systems.
AI-assisted Efficiency
Modern AI tooling supports documentation, validation logic and reporting — always reviewed by an experienced data manager before it reaches your study.
Study types & specializations
Beyond classic interventional trials — experience across the study designs
that shape today's evidence generation.
PASS, NIS & Registries
Post-authorisation safety studies, non-interventional studies, registries and long-term observational programmes.
Real-World Data & Evidence
RWD/RWE study designs, secondary data sources and EMR-enriched data collection.
Rare Disease Studies
Small populations, complex endpoints and highly specific data structures — handled with care and precision.
MedTech & Medical Devices
Device and diagnostics studies with their own regulatory and documentation requirements.
HEOR, Market Access, AMNOG & HTA
Data structures and evidence packages that support health economics, AMNOG dossiers and HTA submissions.
Phase I–IV Interventional Trials
From early phase through large multinational Phase III/IV programmes across therapeutic areas.
How I can support your team
Book me for the role your study needs — as a lead, as a specialist or as interim support at the interface of data management, EDC, clinical operations and IT.
2010 – 2025
IQVIA — 15 years, thereof 9 years Data Manager Lead
Leading data management teams across international trials, EDC builds, reporting automation and process improvement.
Earlier
Metronomia CRO & Kendle CRO
Hands-on clinical data management and EDC work in full-service CRO environments.
Today
Independent Consultant — Your Pharmachecker
Freelance clinical data management and EDC consulting for pharma, biotech, MedTech and CROs.
Recognition & contributions
IT Employee of the Year — Munich, 2018
Awarded for outstanding IT contribution in a clinical data environment.
IQVIA German Award 2021 — Silver
For the development of a new pricing tool used across the organisation.
Publications & Scientific Contributions
Co-author on 15+ peer-reviewed and conference contributions in HTA, AMNOG, market access, real-world evidence and rare disease (ASMD).
Working in German, English and Romanian
Direct communication with sites, sponsors and teams across international studies.
How we work together
A transparent process, clear communication and no surprises —
that is how we deliver reliable data quality.
Discovery Call
We clarify study objectives, system landscape, timelines and your specific data quality requirements.
Setup & Design
eCRF design, data validation, workflows and the monitoring plan are tailored to your study.
Live Conduct
Ongoing query management, data review, reconciliation and close alignment with your clinical study team.
Lock & Handover
Clean file preparation, database lock, archiving and handover-ready documentation for your submission.
Ready for clean trial data?
Let's have a short call about how I can support your clinical data management — no obligation, project-based.
Pricing tailored to your study
Rates are based on project scope, study phase, complexity and required level of support.
View detailed consulting rates