Vigicare

Management of adverse drug reaction (ADR) cases

Capitalise on our pharmacovigilance know-how. Vigicare® – our user-friendly ADR management system – liberates your staff from repetitive and time-consuming tasks.

Vigicare® is a web-based pharmacovigilance database via which we perform your statutory electronic reporting obligations on your behalf.

Vigicare® means that we take care of your ADR reports

You simply pass on incoming ADR reports to us. You are free to choose the report format and mode of transmission. Our team of experts will convert the report into a format acceptable to the regulatory authorities (as a rule E2B), verify the reporting obligations and attach a medical/scientific assessment to the report. On your behalf we will obtain any missing information applicable to the case. As a client you can monitor the current status of each case via the Vigicare® portal.

Electronic reporting by mouse click

Upon completion, the report and the medical evaluation can be released via the Vigicare® portal with a simple click of your computer mouse. We manage the electronic reporting process and you can access the feedback of the regulatory authorities – quickly and conveniently. All case reports are stored in a pharmacovigilance database, and are available for subsequent analysis in connection with signal generation and the preparation of PSURs.

Vigicare® also means full scalability

You have the option of integrating Vigicare® – in whole or in part – into your company’s internal processes:

• If your company has its own web-based pharmacovigilance database, you can process ADR cases within your system.
• If your company has clinical experts with special experience relating to your medicinal products, we will perform the scientific assessment in collaboration with your team.
• If you have not yet registered for electronic reporting with the European Medicines Agency we will carry out registration on your behalf.
• Vigicare® can be used for approved medicines as well as for medicinal products that are still undergoing clinical trials. In this case we will assume responsibility for reporting ADRs to the competent ethics commissions and the principal investigators.
• Vigicare® can be seamlessly combined with other safety-related YES services (e.g. Vigilit®) and with the preparation of PSURs.