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    • PV Services

    Our range of pharmacovigilance services contains all tasks from data entry to entire processing of cases from different sources including literature search, medical writing, creation of PSURs and DSURs.

    An important aspect is the highly modular and fully flexible structure of our services that allows our clients to choose just required items or to combine them according to individual needs.

    Our portfolio includes currently the following services that can be combined depending on clients' needs: 

    Data entry

    Data entry service includes entry of case data from any kind of data records. The Minimum Data Entry Service includes entry of small sets of data into a predefined record format. The Full Data Entry Service includes entry of all case-relevant data and storage of source documents in a defined way. The data records can be provided as files, CRFs, listings, AE/ADR information from CTRs as well as from other sources.

    Clinical trials

    We support the pharmacovigilance departments of our clients in the conduct of clinical trials.

    Coding

    Our extensive know-how in the field of coding with MedDRA® and development of coding tools enables us to perform coding tasks independent from any database.

    Medical assessments

    We assess adverse events with regard to intensity, outcome, severity, labelling/listedness and causal relationship and prepare related medical statements.

    Medical writing

    The medical writing service includes the following issues:

    • final study reports including cover letter
    • PSUR / DSUR according to E2F and GVP
    • opinions on single cases
    • narratives.

    Literature search and management

    This service includes the following issues:

    • literature search
    • screening of abstracts according to client's requirements
    • ordering of relevant articles
    • full processing of cases with AEs/ADRs including reporting
    • management of literature sources in a database

    Holiday replacement / temporary support

    Thanks to our wide knowledge of different substances and our comprehensive experience collected over the years we are able to provide any kind of temporary support.

    Reporting

    The reporting service includes creation and transmission of XML files in E2B format to EMA, FDA and other local authorities. Furthermore we create and transmit reports in paper form like CIOMS I or MedWatch. Additionally we prepare line listings according to CIOMS II and additional standardized types of line listings with extended fields.

    Full Service (if required together with PV database saphëus)

    In case a full pharmacovigilance service is required, we offer it inclusive PV Database saphëus. We enter, code and assess the case data and in case of reporting obligation we report the case electronically or in paper to affected authorities. The full service includes additionally creation of files, PSURs, DSURs and any kind of pharmacovigilance work.

    Consulting

    We consult our customers in their efforts to develop and optimise their processes. This includes writing of SOPs and working instructions.