How Vigintake Works with the Safety Database You Already Use, from Argus and Veeva to Ennov and EudraVigilance
When we show Vigintake to a pharmacovigilance team, one of the first questions is whether they would have to change their safety database. They would not. Most teams chose their database years ago, validated it and wrote their SOPs around it, and replacing it is a project that takes several quarters. Vigintake sits before the database, in the part of case processing that is still done by hand in most companies.
What happens before a case reaches the safety database
A report arrives as a PDF, an email from a partner or an E2B file from a licence partner. Someone has to read it, check the four minimum criteria, type each field into the database, code the reported terms in MedDRA and write the narrative. Vigintake reads the source and fills the E2B(R3) structure, proposes the MedDRA codes and drafts the narrative. A safety scientist then checks every field against the source document and approves the case before anything leaves the system.
How the approved case gets into your database
The case leaves Vigintake as an E2B(R3) file, which is the ICH format that every database used for EudraVigilance and FDA reporting already imports. Nobody has to build or validate a custom connector on the database side, and the database remains your system of record, so submissions, follow-up rules and periodic reports stay in the process you already have. Before export, each file goes through six checks: data types, mandatory elements, a crosswalk between the file and the stored case, XPath conformance, the EMA business rules and the E2B(R3) schema.
Which safety databases are used in the US and in Europe
There are no independent market share figures for safety databases, and the numbers that circulate come from the vendors themselves. Oracle says Argus has more than 400 customers and that over 70% of the drug case reports in the FDA's FAERS database come from Argus. ArisGlobal says LifeSphere has more than 300 life sciences customers. Veeva does not publish a recent Vault Safety customer count, but it keeps adding large pharma accounts. In Europe the picture is more spread out: large companies run the same three platforms, while mid-size companies and pharmacovigilance service providers often use European vendors with lighter set-ups.
The list below covers the databases we come across most often. Any of them can receive cases from Vigintake because all of them import E2B(R3).
| Safety database | Company | Where we see it |
|---|---|---|
| Argus Safety | Oracle (US) | Large pharma and CROs, US and Europe |
| LifeSphere Safety (earlier ARISg) | ArisGlobal (US) | Large and mid-size pharma, global |
| Vault Safety | Veeva Systems (US) | Pharma already on Veeva Vault, growing in Europe |
| IQVIA Vigilance Case | IQVIA (US) | Companies that outsource pharmacovigilance to IQVIA |
| Safety-In-A-Box | RxLogix (US) | Mid-size pharma and biotech |
| Cloudbyz Safety and Pharmacovigilance | Cloudbyz (US), built on Salesforce | Biotech and mid-size companies |
| Ennov Pharmacovigilance Suite | Ennov (France) | Mid-size pharma, human and veterinary |
| SafetyEasy | EXTEDO (Germany), originally AB Cube (France) | Small and mid-size companies in Europe |
| HaloPV | Insife (Denmark), part of Qinecsa | Mid-size pharma and CROs |
| Flex PV | Flex Databases | Small pharma, biotech and academic sponsors |
| Tepsivo Safety Database | Tepsivo (Finland) | Small companies, fixed monthly price |
| Clinevo Safety | Clinevo Technologies (Netherlands) | Small and mid-size companies |
| Vigilazierta R3 | QbD Group (Belgium) | Small and mid-size companies in Europe |
| PvEdge | Sarjen Systems (India) | Generics and mid-size companies |
| EudraVigilance and EVWEB | European Medicines Agency | Companies that enter cases directly in the EMA system |
| VigiFlow | Uppsala Monitoring Centre (Sweden) | National medicines authorities |
Companies that keep cases in an in-house database or a spreadsheet can also use Vigintake. In that case the E2B(R3) file becomes the structured record kept for each case.
Which teams this is most useful for
Pharmacovigilance service providers and CROs get the most from it, because they handle clients on different databases and can use one intake process with one output format for all of them. Small and mid-size companies on a lighter database or on EVWEB use it so that one person no longer does intake, coding and narratives by hand. Large safety teams on Argus, LifeSphere or Vault Safety use it to reduce manual data entry without touching their validated core system.
How to try it with your own cases
Send us two or three anonymised source documents and we will process them with you in a 30-minute call, from upload to the E2B(R3) file that you can import into your own database. Get in touch or read more about case processing.