Safety System & Database Implementation

SAFETY SYSTEM & DATABASE IMPLEMENTATIONedcblog

Pharmacovigilance is increasingly becoming a very crucial step in the drug and device development cycle, mostly due to increased regulations by the EMA and FDA (as well as local authorities) who are aiming to improve patient safety in both clinical development and post-market. Defining user requirements and choosing a fit-for-purpose pharmacovigilance system, database and reporting system are the first crucial steps in a compliance strategy.

PM Clinical, in collaboration with its strategic technology partners, can support with:

System Implementation

  • Support in the definition of business processes and User Requirements
  • Validation Plan and Report, Risk Assessment, traceability matrix
  • Architectural design definition
  • System Implementation, configuration and test
  • Support for product integration
  • Data migration from legacy PV systems
  • System training for users

Hosting Services

  • Servers, database and network management
  • Infrastructure fully qualified through design documentation and IQ qualification
  • Backup and recovery services
  • Implementation system, test and configuration
  • Network services (Internet access, firewall protection, security and intrusion detection)
  • Disaster recovery plan for critical application and backup site
  • Helpdesk and support services