There is advantage in centralising all safety data, clinical data, analysis and reporting with one provider. By combining Bio Soft Research substantial  medical writing and pharmacovigilance expertise, we offer a fully compliant and high quality complete package of pharmacovigilance services. Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximise product potential, whilst ensuring patient safety. From outsourcing of individual activities, to the set-up and management of an effective and efficient global pharmacovigilance system, Bio Soft Research  provides solutions specific to the requirements of our customer’s organisation and products.
From Phase I to IV we cover drug and vaccine safety right through the development cycle ensuring that ICH Good Clinical Practices are fulfilled. We have a passion to provide excellence and solutions for the services you require.

Bio Soft Research offer the following pharmacovigilance services:

    • PV Consultancy and Project Management
    • Serious Adverse Event Case Processing of Initial/Follow-up reports
    • MedDRA coding
    • Case Narratives
    • Medical Monitoring
    • Global Expedited Case Reporting
    • EudraVigilance reporting using EVWEB
    • Responsible Person for EudraVigilance
    • Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) entry and maintenance
    • SafetyData Management & Global Safety Database
    • Legacy case transfer
    • Signal Detection & Evaluation
    • Development Safety Update Report (DSUR) preparation and submission
    • Global Literature Search & Review in support of the DSUR
    • Monthly compliance and status reporting
    • Pharmacovigilance Awareness Training
    • Reconciliation of Serious Adverse Events
    • Risk Management
    • Study documentation review and update, including protocol and Investigator’s Brochure