It is commonly known in the pharmacovigilance (PV) industry that the costs for a safety database can be huge if you have a large number of safety reports, many user licenses and the safety database software your organization is using is from the large software houses.

If you have realized that the expensive solutions large companies charge for add very little bang for the buck and decided you want to save on your safety database costs and switch to a more efficient option, for example Tepsivo Safety Database, you might run into a problem that you had not thought about: migration costs.

Theory & Reality of Data Migration

The Middleman

Often, the traditional PV safety database systems are sold and operated by service providers and licensing partners, to whom we’ll refer to in this blog with the title “the Middleman”.

This means that the pharmaceutical company, the marketing authorization holder, the regulatory authority, or the CRO, who is responsible for the drug safety reporting, technically doesn’t operate and manage the PV safety database. The pharmacovigilance safety database is owned and operated by the Middleman who are performing drug safety services, including the database, for their customer (the party legally responsible for drug safety reporting).

Migration Is Simple

Now, imagine you want to move your adverse event data from the expensive pharmacovigilance database software to your new affordable PV database. Because the drug safety related data should be in the same format, ICH E2B R2 or R3, this process of migrating drug safety data should be relatively easy.

You either just export the ICSRs / SUSARs from the old database and then import them to the new database. In layman’s terms: downloading and uploading the files. Or, you can set up a connection from the old safety database to the new safety database, either using the AS2 gateway technology used by most pharmacovigilance safety databases, or with an API connection that is more generally used technology available in most modern software.

Because this is very easy work, in an ideal situation the process should be free or there should not be any additional costs to you in addition to the time spent by your PV/IT specialist. If you were using a PV service provider, most likely you would be charged for a few hours of work (“few” being used sarcastically here) to document the migration plans, perform the actual downloading and uploading or setting up the connection and sending the files and then finally reviewing (validating) that the migration has been completed successfully – meaning that all case files have been transferred successfully.

To a person naive to the world of pharmacovigilance / safety database services even this might sound like an exaggeration and a bit annoying paper pushing, but this really is the ideal dream situation, which you will almost never achieve unless you use software like Tepsivo Safety Database and forward thinking safety database service provider to perform the data migration. To achieve a smooth, fast and cost-sensitive migration, and any process related to health and safety data, you need to truly own your data and you must be in charge of the data and what happens to it.

The Hostage Situation

In practice, you should be prepared for a completely different kind of scenario, because you are not just switching software but you are also ending your contract with the Middleman, who at this point can turn out to be a kidnapper holding your data hostage.

The download of the cases can cost you dozens of euros per case because the work is done manually by the safety database service provider / company hosting the safety database and they include mandatory “quality” activities to the basic migration.

This means that if you have had a product for years, the cost of just downloading the safety cases can be around tens, even hundreds, of thousands of dollars just because the service provider holds your data hostage and they can slap unlimited amount of excuses why it is so expensive to get the data out: data migration plan, difficult export of the files, quality control of each case, uploading the files to a safe location, reviewing that the files are in this safe location, documenting that the files are in the safe location, and other nonsense.

In reality, even if someone would perform all these activities this still should not take more than a few hours of work from one qualified PV specialist, but by adding more and more processes and subject matter experts, the kidnapping service provider can add dozens, if not hundreds of billable hours.

To be clear, it isn’t just the “Middleman” that is the culprit here, the traditional PV software providers also tend to write in insane costs to their contracts for what basically can be a click of a button, just to release the data that belongs to you.

Unfortunately, there isn’t much you can do because the Middleman controls your drug safety data and the data can be in a PV software that doesn’t allow an easy way out. To avoid this kind of situation or to get out of one with the least amount of damage as possible, read the next part.

What should you do?

Safety Database Evaluation

When purchasing a safety database software, ensure that there are no hidden costs related to the setup, cancellation or any other stage of the life-cycle. When talking about the migration of pharmacovigilance data in or out of the PV database, ensure that you are able to import and export reports at all times and that you do not rely on the PV service provider or PV software provider to do this on your behalf.

And that’s really all there is to it:
1. No hidden costs
2. Full control over your own data.

Then you are free to do whatever you want with your data. If you decide that the safety database software you are using does not meet your requirements, you do not have a need for the software any more or you for some other reason need to transfer the data from database A to database B, you can do that following your own processes and timelines, without surprise costs.

Searching Way Out

If you already find yourself being ransomed for your safety reports by a Middleman or the software vendor, you have a few options to avoid or to minimize the extra costs.

First, think if you really need the versions of the drug safety reports in the old safety database. If the reports are something that you have reported to EudraVigilance, FAERS or MHRA ICSR Submissions portal, or if the reports have been downloaded from these authority databases, you should be able to download all the reports from these authority databases with the related acknowledgement files, provided you still have sufficient access.

If there are additional assessment and review fields in the old pharmacovigilance database software, that ICSR / SUSAR management related information might be stored somewhere else (Excel, SharePoint) and you do not need them from the drug safety database. From a legal perspective, you need to have the safety reports and that’s it.

You might also be able to export the report information through some type of frontend solution you are using for the safety database. If the exported Excel / CSV files contain all the relevant data fields, it is possible to reconstruct the safety reports in the new safety database by mapping the table fields to database fields and a custom script that performs the generation of the safety reports based on the data in the table. In these situations, you can contact a pharmacovigilance consultancy with sufficient IT knowledge, who have the experience developing these scripts and might have one readily available.

Conclusion

To avoid unplanned pharmacovigilance costs during migration, or any other safety database related process, it is important that you choose a pharmacovigilance database software with no hidden costs and a pharmacovigilance service provider with clear and transparent pricing. The PV database solution should also give you full control over your own safety data.

If you are already being asked crazy amounts of money to migrate safety reports, there can be ways to avoid those costs or at least reduce them significantly. You can try the tricks suggested above or discuss with a person familiar with migrations and pharmaceutical database solutions.