Pharmacovigilance

Pierrel Research Italy offers full Pharmacovigilance services, including:

• Collection, assessment ,and transmittal to the Sponsor ,ECs, CAs of the SAEs from clinical trials
• Collection, assessment, and transmittal to the Sponsor, Eudravigilance, CAs and ECs of the SUSARs from clinical trials
• User Access to Hypervigilance, a validated, Oracle web based, ICH E2B compliant drug safety database , which allows ICSRs upload and download to / from Eudravigilance , through an XML file.
• Revision and update of Sponsor Pharmacovigilance SOPs
• Pharmacovigilance Audits
• Training of personnel
• Management of all the PV regulatory duties , on behalf of the Marketing Authorization Holder (MAH)
• Safety Risk Management