saphëus® is a modern und future-proof pharmacovigilance database focusing on user-friendliness and special needs of a good pharmacovigilance.

saphëus® is a pharmacovigilance database fully compatible with E2B R3. The E2B data is stored in saphëus® in R3 Format. This allows creating and importing of XML files directly in E2B R3 format. However, the E2B R2 format is still supported. saphëus® uses the valid BFC rules to convert R3 data in R2 format and vice versa.

As a Full-Pharmacovigilance database saphëus® includes various additional fields and data groups.

Cases from different sources can be entered in saphëus®. This includes spontaneous reports, reports from NITs and ITs, literature cases, reports of product complaints etc. Serious as well as non-serious cases can be managed in saphëus®.

Print-outs for PSURs and DSURs can be created in a fast and easy way according to GVP Module VII and CT-3 / E2F.

The extended multilingual MedDRA® Browser supports users in coding of terms in a comfortable way.

The integrated Query Assistant supports users to create queries to find any case data and to select and output it in a desired way. There are no limitations in creation of queries.

saphëus® includes an intelligent and very well working narrative and medical assessment generator. The generated texts are written in good English.

The integrated gateway for exchange of xml files and acknowledgements can be used without additional costs. saphëus® uses this gateway to manage XML files and acknowledgements directly.

All parts of development, testing, validation and data storage are located exclusively in Germany. Therefore the German and European laws for data protection are affected.

Users get personal support from our helpdesk team without a computer based routing. If required our experts from PV Services department can be consulted on all aspects of pharmacovigilance.

Also in the way to use saphëus® through the Internet we have implemented a beneficial solution. This pays of in several regards for our clients:

• performance of saphëus® is excellent
• users work with saphëus® at any time on a validated environment independent from hardware and software environment used on user side
• connection to saphëus® is safe and encrypted and additionally tunnelled by VPN
• no data will get lost in case the internet connection will be aborted

There are no special requirements regarding user's environment. saphëus® can be used with standard retail PCs, Notebooks, Tablets and iPads®. We recommend MS Windows®.

Another characteristic of saphëus® is its multi core based structure. This makes it possible to split one database environment into different Case Owner Units (e.g. different affiliates) of one company. The data of each core is fully enclosed.

Due to large size of saphëus® and its wide range of functions we are able to present only an excerpt of it in this small description. We are happy to send additional information and present saphëus personally. Please do not hesitate to contact us.

The XEVMPD database -iris- has been developed to enter, manage and transmit of product and variation data in accordance with article 57(2) of the EU regulation.

The following additional smart and usable functions help users to enter and manage XEVMPD data in a simpler and faster way.

The integrated extended multilingual MedDRA® browser makes coding of indications much faster and easier.

-iris- includes a function to change all affected data automatically in case the QPPV, PSMF location etc. has changed. After this global update all affected products can be transmitted to XEVMPD with one step only.

The integrated query function allows users to find required information within the whole database.

A gateway for electronic transmission of XML file is integrated in -iris-. It can be used without additional costs. If required the gateway can be used additionally for import of XML files in XEVPRM format.

An integrated user-friendly copy function can be used to copy similar product data. It increases significantly the data entry process for such products.

The monitoring and listing of time periods is very useful for transmission of variations.

Due to the structure of -iris- as an XEVMPD database no data has to be entered again and again in case of any future changes. In this case just the affected data will be changed and transmitted.

All parts of development, testing, validation and data storage are located exclusively in Germany. Therefore the German and European laws for data protection are affected.

Users get personal support from our helpdesk team without a computer based routing. If required our experts from PV Services department can be consulted on all aspects of pharmacovigilance.

Also in the way to use -iris- through the Internet we have implemented a beneficial solution. This pays of in several regards for our clients:

• performance of -iris- is excellent
• users work with -iris- at any time on a validated Environment independent from hardware and software environment used on user side
• connection to -iris- is safe and encrypted and additionally tunnelled by VPN
• no data will get lost in case the internet connection will be aborted

There are no special requirements regarding user's environment. -iris- can be used with standard retail PCs, Notebooks, Tablets and iPads®. We recommend MS Windows®.

Another characteristic of -iris- is its multi core based structure. This makes it possible to split one database environment into different MAHs (e.g. different affiliates) of one company. The data of each core is fully enclosed.

Due to large size of -iris- and its wide range of functions we are able to present only an excerpt of it in this small description. We are happy to send additional information and present -iris- personally. Please do not hesitate to contact us.