Business Consulting

 

Safety and Pharmacovigilance

Pharma IT has an experienced team ready to assist you within pharmacovigilance. Our main competences lie within:

  • Safety management in relation to clinical trials
  • QPPV services
  • Back-up for local safety officers during illness or leave
  • Strategic advice and liaison with authorities
  • Preparation and review of pharmacovigilance documents:
    • Company Core Safety Information (CCSI)
    • Periodic safety update reports (PSUR)
    • Development safety update report (DSUR)
    • Risk Management Plans (RMP)
    • Addendum to Clinical Overview (ACO)
  • Data entry and medical assessment of individual case safety reports (ICSR) from various sources, including:
    • Writing of safety narratives and company comments
    • Coding of adverse events, medical history and concomitant medication
    • Assessment of seriousness, listedness and causality
  • Reconciliation with partners, QA and medical information
  • Outsourcing of case processing
  • Pharmacovigilance system master files (PSMF)
  • Review of marketing material
  • PV agreement negotiation
  • Pharmacovigilance SOPs

Local safety representative

If your local Danish safety representative is absent, or you have a particularly busy period, our consultants are all experienced with the Danish pharmacovigilance legislation, and with safety training of sales staff, writing local SOPs, doing reconciliations and other tasks normally handled by your Danish safety representative. Please contact us if you have a shorter or longer term need for assistance.

QPPV services - EU Qualified Person for Pharmacovigilance

Due to medical expertise as well as numerous years of pharmacovigilance experience, our Danish-based consultants can act as EU-QPPV for your small pharmaceutical company and offer assistance in setting up the necessary procedures to support this role.

Assessment of Individual case safety report (ICSR)

The team is trained in data entry in the major used safety databases, and our consultants can handle every step from book-in, through data entry, quality control, safety review, medical review and distribution/reporting to authorities and partners.

Risk Management Plans (RMPs)

With the release of the EU GVP Module V in March 2017, pharmaceutical companies need to adapt to a new standard of reporting. Our consultants are experienced in the old and the new format and can help you transfer into the new format; and additionally we are ready to help you with the content as well due to our experience across many different therapeutic areas.

Pharmacovigilance System Master File (PSMF)

Our consultants are very experienced in maintaining and building the PSMF for small to large size pharmaceutical companies. Often the demands of the PSMF needs to be reviewed and complied with before the first marketing authorization is granted in the EU, so please contact us, if you need strategic advice on how to set-up your system most efficiently and compliant. In addition to the business consulting, Pharma IT is also able to assist you with an electronic solution to tailor and implement to maintain the PSMF

Pharma IT can assist with all aspects of clinical data management including;

  • eCRF and database design,
  • Data entry and validation
  • Query handling
  • Protocol deviations
  • SAE reconciliation
  • Quality control
  • Data import/export
  • SAS and SQL programming
  • Data migration
  • CDISC SDTM standards
  • MedDRA/WHODrug coding
  • Risk based monitoring
  • Data management oversight