FAQ

I can use Excel or Access for my pharmacovigilance data. So why should I prefer Safety-Easy to them?

Safety-Easy ensures that you meet all regulatory requirements: e-transmission, 21 CFR part 11, pharmacovigilance Best Practice, ICH guidelines E2A, E2B, E2C, E2D, Volume 9Pharmacovigilance guidelines, etc.
In the event of an audit your system will be compliant.

What do I need to install for Safety-Easy to work?

You must install FireFox and be connected to the Internet. That's all you need to do. FireFox is a W3C-compliant web browser. It's a next generation browser. Free, robust and secure, it is platform-independent (works with Windows, Mac and Unix).

What is a hosted application?

This is a software application for which both the software itself and the data are hosted externally by a specialist data preservation organization on a dedicated server. You don't have to worry about hardware issues (no need for a new server or dedicated workstations), or about database administration or IT management (no need for backups, etc.). No need to tie up internal resources. Your DBA and IT staff are free for their core activities.

 What about EudraVigilance's EV WEB application? Couldn’t I use that as my pharmacovigilance database system?

EV Web is designed to let you input and transmit SUSARs and ICSRs but it cannot replace a pharmacovigilance database system. It cannot produce line-listings or summary tabulations. There is no provision for audit trails, nor for reporting management, nor for everyday pharmacovigilance tasks such as mail follow-up.

How does Safety-Easy stand out from other solutions available on the market?

It is so simple to use: 10-15 minutes and you are done. Safety-Easy comes with all the features you need (case input, regulatory reports, audit trail, XML E2Bimport/export, etc.). It's price is very attractive compared with that of other solutions on the market.

How long does it take to deploy Safety-Easy?

Deployment is quick (allow about six weeks). Since the application is externalised you will only need to spend minimal time on parameter set up and implementation.

I have to manage both clinical trial cases and spontaneous notifications. Is Safety-Easy right for me?

Yes, Safety-Easy is the right tool for both situations. All you need to do is choose an option in a selection field.

My company is a corporate. Can we use SafetyEasy?

Yes, indeed you can. You can let your affiliates have access, too. You can let them use given features or limit them to consulting your data.