Data Management
MedDRA coding of adverse events occurring in clinical trials is often outsourced to non-medical personnel…
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/Eudravigilance
As a sponsor conducting a clinical trial within the European Economic Area (EEA) sponsors of clinical trials are obliged to be registered as an organisation at the European Medicines Agency’s (EMA) SPOR system.
In the registration process a responsible person (RP) for EudraVigilance (EV) needs to be elected. To hold this position, training on the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and the submission of individual case safety reports (ICSRs) within the Eudravigilance system are a prerequisite. As a holder of both qualifications I can support you not only as the RP but also conduct the necessary submission in compliance with regulations.
In accordance with Article 57 of the European Commission both marketing authorization holders (MAH) as well as sponsors from clinical trials are obliged to submit medicinal product data to the EudraVigilance XEVMPD.
We offer:
- EMA Sponsor Registration
- Responsible Person for EudraVigilance
- EudraVigilance XEVMPD Submissions
- EudraVigilance ICSRs Submission
Data Management
MedDRA coding of adverse events occurring in clinical trials is often outsourced to non-medical personnel which may lack experience in correct allocations of PT/LLT/SOC terms. This can lead to wrong conclusions on drug safety during the clinical development programme of your IMP. Reasonable medical input and expedient query raising to investigators from medically experienced individuals prevents misleading data.
- MedDRA Coding
- WHO ATC Coding
- Safety Data Management
- Query Raising
Consulting
Aquila MS can offer you full support throughout the process of your study and guide you through the jungle of legal requirements needed to safely conduct trials in compliance with pharmacovigilance regulations.
As a medical doctor with 9 years of experience in pharmacovigilance practices in over 15 studies conducted within the European Union my services reach from individual work packages to full pharmacovigilance management including constant medical monitoring.
If required from your side, assistance starts at the draft protocol and will end with the last case narrative of the final clinical study report.
Due to my activities both in the university hospital environment as well as in clinical research I can offer a large network of clinicians and experts in the field available for even the most specific medical issues arising within trials.
We offer:
- EU Regulatory Requirements Consulting
- Assistance in PV Requirements and Data Handling