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Whether you want someone to handle your clinical study in its entirety, assist with specific parts of it or outsource a certain staff, you can choose City as dependable partner. |
Medical Safety
OUR PHARMACOVIGILANCE EXPERTS SPECIALIZE IN MANAGING CLINICAL TRIAL AES AND SAES, INCLUDING INITIAL RECEIPT, CASE PROCESSING AND FOLLOW-UP, MEDICAL REVIEW, AND CLOSURE. OUR SERVICES INCLUDE:
- AE case processing including SAE management and expedited reporting in the US, EU, and other countries
- Responsible Person for EudraVigilance
- Generation of MedWatch 3500A/CIOMS I forms
- Preparation of periodic safety update reports and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction