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ClinFo1T has been a leader in Vigilance Services provision covering the whole MEA region, Turkey and Persian countries.
Our primary goal is to assist our clients in having a solid Vigilance system (Pharmacovigilance, Materiogivilence, Cosmetovigilance, and Nutrivigilance) and ensure full compliance with local and International regulatory requirements.


We are responsible for setting-up your PV System through:


1 Local Contact Person for Pharmacovigilance (LCPPV) Provision

Through our network of local personnel and partners, 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, and ensure proper appointment to the local competent authorities, where applicable.
In addition to LCPPVs, deputies are provided and kept up-to-date to secure business continuity.

HEalthCAreVIgilance or HECAVI is a pioneer solution platform and services created by Clinfo to serve health sponsors and re regulatory in pharmaco, medico and nutritional vigilance areas.


2 Local Literature screening

our expert Literature Screening team is responsible of managing and reporting safety information collected from locally applicable medical and scientific literature by:

  • Setting-up search strategies and key terms
  • Periodically monitoring literature releases as per local regulations
  • Analyzing search results in English and local languages
  • Providing medical translation of collected safety information into English

3 ICSRs (Individual Case Safety Reports) Management

we manage all ICSRs during clinical trials and post-marketing through:

  • Developing and applying proper case collection strategies.
  • Electronic tracking.
  • Narrative Writing.
  • Medical coding (MedDRA, ATC, etc.)
  • Translation, assessment & follow-up
  • Reporting to local authorities and following up on approvals.

4 Risk management

We provide support for additional risk management and risk minimization activities required for safety concern in addition to analysis of benefit risk balance.


5 PV Documents Management

We maintain all your PV documents to comply with local guidelines and reporting requirements this includes:

Periodic reporting

  • We are highly experienced in the delivery of aggregated reports such as PSUR, PBRER and RMP
  • Setting up periodic submission calendars
  • Performing and following-up on submissions.

Pharmacovigilance system master file

Creating and maintaining local PSMF/PSSF (Pharmacovigilance System Master File/ Pharmacovigilance Sub-System Master File) for your product application.

6 Regulatory Intelligence

Our team constantly monitors local PV regulations, websites, newsletter and international standard organization to update you on any changes and provide consultancy to ensure compliance with the local PV practice.


7 Pharmacovigilance consultancy

  • Our team provides guidance and support in the development of SOPs working practices supporting for your pharmacovigilance activities and related Quality system
  • Ensuring proper and continuous PV training for all PV and non-PV personnel
  • Developing project and unit KPIs
  • Managing CAPAs reporting and implementation
  • Preparing your company for potential/upcoming audits and local authorities’ inspections

8 Medical device vigilance

Clinfo1t provide full range of services on medical device vigilance through:

  • Incident captured, collated, investigated and where applicable reported per national and regional requirement.
  • Field safety corrective action generation and submission.
  • Creation and distribution of Field Notices (FSNs)
  • Periodic reporting.