Pharmacovigilance

In addition to other GxP services, SanaClis offers comprehensive pharmacovigilance (PV) solutions to both associated as well as individual standalone PV services, fully meeting the needs of our clients across a wide range of therapeutic areas and the majority of all geographical locations. SanaClis operates exclusively compliant pharmacovigilance (PV) systems and is aligned with the European Medicine Agency Guidelines on Good Clinical (GCP) and Good Pharmacovigilance Practices (GVP) and 21 CFR part 11 (US-FDA) regulatory requirements.  SanaClis is exceptionally experienced in the provisions of complex PV-related life cycle management of your product and offers customized trainings, project management and consultancy services.

Our pharmacovigilance capabilities and services include: 

PHARMACOVIGILANCE SERVICES IN THE CLINICAL TRIAL PRODUCT DEVELOPMENT STAGE

Clinical Trial Planning PV Activities

  • Organization of Kick-off meetings
  • Preparation of Safety Management Plans and workflow setting
  • The subsequent revision of both the EDC systems and all relevant study related documentation from expert Pharmacovigilance view points
  • SAE Reconciliation Plan
  • Conception of Sponsor and Medicinal Product profile in EudraVigilance and other relevant Authority reporting systems

Clinical Trial Sponsor and Site Support

  • A comprehensive and thorough PV related trainings provided to investigators and corresponding site personnel
  • The provisions of consultancy services in relation to the Sites with particular regard to the correct implementation of all study related document requirements and form completion
  • Incorporation of all services relating to Safety Physicians with Medical Monitoring capacity and general medical consulting
  • Provision of expertise on safety-specific national regulatory requirements in relevant countries

Comprehensive SAE/SUSAR Management and Case Processing

  • Encompassing medical event and product coding
  • Electronic or paper based reporting to Authorities

Safety Database Hosting

Preparation and Submission of all Types of Periodic Safety Reports

Involvement in Data Safety Monitoring Board Activities

  • Preparation of a DSMB Charter, pharmacovigilance and medically related data for DSMBs 
  • DSMB Membership 
  • Participation in DSMB conventions on behalf of the Sponsor

Management of all PV Related activities in the UK after Brexit


POST-MARKETING PHARMACOVIGILANCE SERVICES


Establishment, preparation and update of a Pharmacovigilance System Master File

Preparation and involvement of expert input into the Risk Management Plan

Full Life Cycle Management of a Product
    • Including Individual case Safety Report Management with the accompanying electronic exchange of ICSRs between EMA, national competent authorities (NCAs) and marketing authorisation holders (MAHs)

Signal Detection and Risk-Benefit Assessment

  • Consulting and provision of advisory capacity

The provisions of global solutions thereby supporting any Medicinal Product across all therapeutic areas and geographical locations

Medical Writing of Post-Marketing PV Related Documents in Accordance with GVP and other Relevant Regulations, Document Submission


    OTHER SERVICES


    SOP Development

    Preparation of tailored specific PV presentations including the provision of respective andrelevant trainings

    Monitoring of regulatory compliance

    Constant communication with the appropiate Authorities on behalf of our clients

    The Provisions of a Qualified Person for Pharmacovigilance service in EU countries 

    Highly experienced Physician 24/7 Availability