ClinFo1T has been a leader in HealthCareVigilance Services provision covering the whole MEA region, Turkey and Persian countries.
Our primary goal is to assist you in having a solid HC system and ensure full compliance with local regulatory requirements and provide all your HealthCareVigilance requirements need for establishing HC system.

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

1 Local Contact Person for HealthCareVigilance Provision

Through our network of local personnel and partners, we provide you with the needed contact persons for the conduct of local HC activities and communication with the competent authorities, as per country requirements, and ensure proper appointment to the local competent authorities, where applicable.
In addition, deputies are provided and kept up-to-date to secure business continuity.

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 HC Documents Management

We maintain all your HC 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.

HealthCareVigilance system master file

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

6 Regulatory Intelligence

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

7 Pharmacovigilance consultancy

  • Our team provides guidance and support in the development of SOPs working practices supporting for your HealthCareVigilance activities and related Quality system
  • Ensuring proper and continuous HC training for all HC and non-HC 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.