• 24 rue de Lappe - 75011 Paris
  • info@evedrug.eu
  • +33 (0)6 21 93 82 65
  • Mon - Fri 09:00 - 18:00
  • User's club 2020
  • In 2021, you'll be told everything

Presentation

eVeReport is a software combining Health vigilances (Pharmacovigilance, Devices vigilance, Cosmetovigilance, Biovigilance et Other Studies) and eHealth.

eVeReport is connected with the new eHealth tools My eReport, My eClinical et My eCosmetic, but eVeReport can also be used alone to managing your spontaneous reporting and your clinical studies.

Three main principles :
• The database is outsourced : the maintenance is provided directly by a specialized external host.
• Updates are automatic and comply with the E2B regulation. The database will be always up to date.
• No management of the number of licenses. The number of connections is unlimited.

Screenshots






Specifications

Created using multi-browser Web development tools, eVeReport works identically on all existing Web browsers : Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Safari...

All our applications are secured by an Extended Validation SSL certificate and hosted by an Approved Host of Health Data (HADS) certified ISO 27001 on a robust infrastructure with 99.99% guaranteed availability (SLA). Our host has been audited by the eVeDrug Quality Team. All our databases are supervised, daily backups take place and restoration tests have been executed and qualified. In terms of data traceability, we comply with FDA's 21 CRF part 11 regulations.

The updates take place regularly according to evolution of the worldwide and european E2B regulations. Our Pharmacovigilance databases conform to the E2B(R3) standard.

eVeReport is validated according to GAMP 5 instructions. Documentation concerning the software validation is available to users. The validation file is updated at each upgrade and the users are personally assisted throughout their validation process.

eVeReport has the possibility to evolve and to adjust to the regulations and the user needs. Each demand is examined internally and may lead, according to its relevance or business requirements, to adapted developments.

Thanks to adapted import scripts, we transfer your data from your old vigilance system, regardless of the source of the backup : regulatory or custom XML, Excel files, Microsoft Access databases, etc. We will then send you a complete migration report that you can add to your validation file.

A complete on-site training of two and a half days is provided in order for you to master all software fonctionnalities and proceed very quickly to the data entry in your new system.

Features

CIOMS, MedWatch 3500, CERFA, SUE Form, Form 5, Form 6, PSUR, DSUR, PBRER, MEDDEV... eVeReport integrates all types of paper reporting as well as aggregated listings for Pre-Market and Post-Market.

eVeReport integrates by default the qualitative and quantitative signal detection algorithms.

From key field analysis, easily detect duplicates of any case in the database or of an on-going case.

The MedDRA dictionary is directly integrated into eVeReport and is automatically updated with the new semi-annual versions. Integration of SMQ (Standardised MedDRA Queries), IME (Important Medical Event), and advanced features such as automatic re-encoding of reactions.

Export your cases in E2B(R2) or E2B(R3) format and benefit from our Gateway standard AS2 to complete your submissions with the minimal effort. A Business Rules validation module ensures the validity of your cases at E2B level. Our qualified tools such as the Dashboard or the automatic and configurable daily sending of notification mails, provide the means to permanently guarantee the good management of your vigilance data.

Thanks to our import modules, you can easily import pharmacovigilance cases in R2/R3 format (with detailed consultation of the files in the import SAS, possibility of filtering and sorting for L2A/MLM package imports, import stastistics records), products in xEVMPD format, clinical studies in EudraCT format, and investigators from custom Excel files.

A complete query module allows you to easily search your data, query any fields in the database by applying custom filters and perform all types of extraction in different formats. An integrated query manager allows you to save/explore/share all your queries.

Import your own mail or query templates by easily integrating data from your cases. In the same way, create from scratch your own narrative templates in order to conform to your process.

Set up your own Workflow and adapt it to your internal organization by defining the steps, processing times, and rights for each user profile.

You can set, if necessary, deadlines specific to countries or partners, based on the main criteria of declarability (type of case, severity ...).

eVeReport allows you to totally customize your access via the adjustable management of user profiles. Select which features or parts of the case form each user can access. You can create an unlimited number of new profiles or modify the existing profiles by default.

Report your incidents or requests for change with our ticketing tool directly integrated into the interface (no need for connection to an external service). Our ticketing system includes :
• Priority calculation algorithm
• Integration of attachments (screenshots...)
• Notification mails
• Requestor/technician discussion thread
If necessary, our Helpdesk service can be contacted by email/phone daily, from 8am to 8pm.