Clinical Data · CDISC · RWD/RWE · AI Automation · MedTech · Market Access
From assessment to validated implementation.
Focused first step
Turn a promising idea or inefficient workflow into a grounded decision on where AI or automation can create value.
Request an AI Process AssessmentIdentify practical AI and automation opportunities, expected benefits and the processes worth prioritising.
Assess technical feasibility, system interfaces, data availability, data quality and implementation dependencies.
Define appropriate human oversight and review security, privacy and responsible data handling requirements.
Consider relevant GxP, quality, risk-based validation and traceability needs for the intended use.
Recommended next step: a focused, reviewable pilot.
The recommendation aligns scope, success criteria, controls and evidence with the intended use. Validation requirements depend on risk, context and the applicable quality system; no solution is assumed to be validated or regulator-approved.
From protocol to the first eCRF draft and to final data handover —
tailored clinical data management for every phase.
End-to-end data management for clinical trials — from study start-up to database lock, focused on quality, compliance and on-time delivery.
User-friendly eCRF design in leading EDC systems, including logic checks, edit checks and a clean data structure.
Programming and review of validation rules. Early detection of inconsistencies, implausible values and missing data.
Fast, precise and communicative query handling. Fewer follow-ups, cleaner data and happier sites.
Data Management Plans, Data Validation Plans, annotated CRFs, edit and plausibility checks — all built on SOP-based, inspection-ready processes.
CDASH-conform data capture, SDTM and ADaM mapping and standard-compliant data structures for smooth submissions and statistical analysis.
Custom clinical database reporting with Exasol SQL, Microsoft SQL Server, PostgreSQL, Azure SQL and Oracle — including the DTM SQL Query Reporter.
Work aligned with ICH-GCP, GxP, 21 CFR Part 11 and ALCOA+ principles. Documented, traceable and audit-ready.
Custom scripts, macros, data extracts and reporting solutions to automate workflows and improve data quality across clinical systems.
Modern AI tooling supports documentation, validation logic and reporting — always reviewed by an experienced data manager before it reaches your study.
Beyond classic interventional trials — experience across the study designs
that shape today's evidence generation.
Post-authorisation safety studies, non-interventional studies, registries and long-term observational programmes.
RWD/RWE study designs, secondary data sources and EMR-enriched data collection.
Small populations, complex endpoints and highly specific data structures — handled with care and precision.
Device and diagnostics studies with their own regulatory and documentation requirements.
Data structures and evidence packages that support health economics, AMNOG dossiers and HTA submissions.
From early phase through large multinational Phase III/IV programmes across therapeutic areas.
Benno Jürgen Antoni
Principal Clinical Data Management & EDC Consultant
Senior Clinical Data Manager / Lead · DE · EN · RO
The expertise behind the brand
Your Pharmachecker combines a solution-focused Life Sciences perspective with 25 years of experience, most of it in Clinical Data Management as a Senior Clinical Data Manager / Lead.
Benno Jürgen Antoni is the experienced point of contact for projects spanning clinical data, EDC, clinical operations, project management, market access and IT.
2010 – 2025
Leading data management teams across international trials, EDC builds, reporting automation and process improvement.
Earlier
Hands-on clinical data management and EDC work in full-service CRO environments.
Today
Freelance clinical data management and EDC consulting for pharma, biotech, MedTech and CROs.
Awarded for outstanding IT contribution in a clinical data environment.
For the development of a new pricing tool used across the organisation.
Co-author on 15+ peer-reviewed and conference contributions in HTA, AMNOG, market access, real-world evidence and rare disease (ASMD).
Direct communication with sites, sponsors and teams across international studies.
A transparent process, clear communication and no surprises —
that is how we deliver reliable data quality.
We clarify study objectives, system landscape, timelines and your specific data quality requirements.
eCRF design, data validation, workflows and the monitoring plan are tailored to your study.
Ongoing query management, data review, reconciliation and close alignment with your clinical study team.
Clean file preparation, database lock, archiving and handover-ready documentation for your submission.
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