ClinFo1T has been a leader in Pharmacovigilance Services provision since 2015, covering the whole MENA region, Turkey and Persian countries.
Our primary goal is to assist you in having a solid PV system and ensure full compliance with local regulatory requirements.
PV System Set-up
We are responsible for setting-up your PV system from A-Z by:
• Creating and maintaining local PSMF/PSSF (Pharmacovigilance System Master File/Pharmacovigilance Sub-System Master File)
• Creating and updating all PV SOPs and related Quality System
• Ensuring proper and continuous PV training for all PV and non-PV personnel
• Preparing your company for potential/upcoming audits and local authorities’ inspections
Local Contact Person for Pharmacovigilance Provision
Through our network of local personnel and vendors, we provide you with the needed contact persons for the conduct of local PV activities and communication with the competent authorities, as per country requirements.
Local Literature Screening
Our expert Literature Screening team is responsible for managing safety information and ICSRs collection and reporting from locally applicable medical and scientific literature.
ICSRs (Individual Case Safety Reports) Management
We manage all your ICSRs steps for proper case collection, tracking, MedDRA coding, translation, assessment & follow-up, and reporting to local authorities.
PV Documents Management
We maintain all your PV documents (PSUR/PBRER/DSUR/RMP) to comply with local guidelines and reporting requirements.
Our team constantly monitors local PV regulations to provide you with the most updated information and consultancy for excellent compliance with the local PV practice.