Data Management
Accurate classification and terminology mapping are essential for reliable data evaluation within clinical trials.
EMA/Eudravigilance
When conducting clinical trials within the European Economic Area (EEA) sponsors of clinical trials are obliged…
Consulting
We offer you full support throughout the process of your study and guide you through the jungle of legal requirements needed to safely…
EMA Compliance
Sponsors of clinical trials within the European Economic Area (EEA) are required to register their organisation in the European Medicines Agency’s (EMA) SPOR system.
As part of this process, a Responsible Person (RP) for EudraVigilance must be nominated to oversee compliance with safety data submission requirements.
Holding EMA qualifications for both the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and ICSR electronic reporting, I provide regulatory and technical support to ensure compliant setup and maintenance of EudraVigilance registrations and submissions.
In line with Article 57 of the European Commission, both Marketing Authorisation Holders (MAHs) and clinical trial sponsors are obliged to submit medicinal product data to EudraVigilance (XEVMPD).
My services include coordination, documentation and secure electronic submissions within these frameworks.
Services provided:
EMA Sponsor Registration
Responsible Person for EudraVigilance
EudraVigilance XEVMPD Data Submissions
ICSR Electronic Reporting (Regulatory Transmission Support)
Data Management
Accurate classification and terminology mapping are essential for reliable data evaluation within clinical trials.
With long-standing experience in pharmacovigilance data handling and quality control, I provide independent data management support focused on correct term allocation, query coordination, and documentation oversight in accordance with EMA and ICH-GCP requirements.
Services include:
MedDRA Coding (Preferred Term / Lowest Level Term / SOC Level)
WHO ATC Coding
Data Integrity & Management
Query Coordination & Documentation Oversigh
Consulting
Aquila MS provides comprehensive support throughout the lifecycle of your clinical research projects, ensuring full alignment with European pharmacovigilance and regulatory requirements.
If requested, assistance can start during the early planning phase — such as protocol setup and documentation workflows — and continue through to the completion of final safety deliverables and regulatory reports.
With long-standing experience in both academic and industry-based research environments, I maintain a broad professional network of experts in clinical operations, regulatory affairs and data management, enabling efficient coordination even for complex project structures.
Services include:
EU Regulatory Requirements Consulting
Pharmacovigilance & Data Compliance Support