I am Daniel Funk, consultant specialized in clinical research operations and regulatory compliance, with more than 10 years of experience in the field of pharmacovigilance and related regulatory compliance oversight within the European Economic Area.
Through this work, I have built a broad professional network of experts in regulatory affairs, data management, and clinical research operations, enabling efficient and compliant project execution tailored to your needs.
I support sponsors and CROs in establishing compliant pharmacovigilance workflows, including obligatory EMA registration, Responsible Person for EudraVigilance services, and setup of quality-assured safety documentation systems according to EMA and ICH guidelines.
With long-standing EMA system qualifications (XEVMPD and ICSR electronic reporting) and a decade of experience in pharmacovigilance data integrity, I support sponsors and CROs in ensuring compliant and efficient safety reporting workflows within the European Economic Area.
References
I have extensive experience in pharmacovigilance and regulatory operations across more than 15 clinical research projects (Phase I–III) conducted within the European Economic Area.
I have collaborated with the following companies and sponsors in the context of pharmacovigilance obligations, regulatory compliance and data management for clinical research projects in the past:
- Artery Therapeutics
- Avraham Pharmaceuticals
- BIT Pharma GmbH
- Boehringer Ingelheim
- DataMagik Ltd (Data Management & Statistics)
- Datamedrix GmbH (Data Management)
- NeuroScios GmbH (CRO)
- NSC Therapeutics GmbH
- PharmatrophiX, Inc.