Safety & Pharmacovigilance

photodune-9680632-female-doctor-looking-at-medical-records-on-ipad-sCROS NT understands the pressing issue of pharmaco- and devicevigilance and the need to manage safety data collection and reporting in an efficient and cost-effective manner. We offer, through our sister company, a comprehensive package to help Sponsors manage their safety data during the clinical phases of development and support their PV needs during post-marketing authorization.

CROS NT’s experts work to Europe’s Good Vigilance Practices (GVP) and the FDA’s Guidance for Industry-Good Pharmacovigilance, and can support from data entry and case processing to signal detection and reporting.

Our portfolio of services include:

Data Collection, Case Processing & Reporting

  • Case Collection including external/internal sources
  • Data Entry
  • Coding
  • Query Management
  • Case approval and reporting to Eudravigilance or other regulatory/competent authority
  • Full cycle management of signal detection
  • Periodic Reporting: preparation of PSUR and DSUR according to ICH format
  • Literature screening
  • Preparation and management of Risk Management Plan (RMP)
  • Preparation and management of the Pharmacovigilance System Master File (PSMF)

Quality Assurance and Consultancy for Safety and Pharmacovigilance

  • Safety and Pharmacovigilance Quality Assurance and Compliance consultancy available on a case-by-case basis including an EU QPPV
  • Support for audit and inspection regulations
  • Support for setting up SOPs and quality manuals within your organization
  • Making sense of complex pharmacovigilance legislation and offer support for submissions