At Tepsivo, we believe in fair pricing and we have developed our own safety database solution following that philosophy. We started the development process because we thought that this niche area of the pharmaceutical industry was being exploited by the few players on the market. So instead of collaborating with one of these established players on the market, we decided to become one ourselves, but with a twist.

Tepsivo Safety Database has immediate advantages just because of the affordable fixed prices, which are invoiced monthly without additional hidden costs or tricks. Just to be clear, the prices are much, much more affordable than what most pharmacovigilance veterans are used to. But the price is just one of the differences. The other differences are the positive side effects (no pun intended) that come from the feeling of freedom the fixed prices give.

The perks of a different approach

Unlimited users

Because you have an unlimited number of user licenses for the same price, you can literally add everyone you wish to the system. You don’t have to think about who from your organization you can afford to grant access to the critical safety data of your products.

You can add your contractors, customers, and partners to the safety database because we are not limiting you to just one email domain and we are not looking over your shoulder how many users are in the system.

You don’t need a separate data entry solution just because it is cheaper to do so. With this, we refer to a situation where the license cost of the safety database solution can be so high that the case processing organization may opt to use another, cheaper, solution for the army of data entry personnel. The data from the initial data entry is then sent to secondary data entry to the actual safety database.

You can avoid unnecessary complexity just because of the costs. And if, for one reason or the other, you prefer to have organizations in separate systems, it will surely be still simpler and more affordable to create two or three tenancies in Tepsivo Safety Database. In such case, it’s easier to transfer data from one database instance to another than to use a safety database, where only selected users have the access to, and a separate case intake tool which is used by larger amount of unpaid or cheaper resources (situation where additional steps are required for review and additional data fields to be filled in before the report is entered to the actual PV safety database).

You will have predictable costs for the month and the year, even years, and if your organization grows. Being able to add all the users in the same system streamlines the ICSR and SAE / SUSAR case management process significantly compared to situations where more than one system is used for the process or where only some of the users have the access to create, review and submit reports in the safety database. Having everyone using the same user interface means simplification of the training and communication.

The oversight of safety data, safety database and PV system in general becomes easier. You can give your EU QPPV, Stufenplanbeauftragter, French QPPV, Australian QPPV, Japanese QPPV or anyone else access to the system so that they have both full oversight of the safety information but hands-on understanding of how the safety database works. The same idea applies for the Sponsor or the Medical Reviewer. By not being limited by the number of user licenses, you are flexible to assign roles in the safety database to everyone who needs one. There are different types of roles and levels of access based on the role.

Unlimited cases

As with the unlimited user licenses, the unlimited cases create a situation where you will have predictable fixed costs even if your number of products changes, or the patients of the study report more adverse events than expected.

The number of received cases is more or less out of our customer’s hands, and we would have to eat our words on “fair pricing” if we charge our clients based on the number of cases which they can typically do little to influence (especially during clinical trials).

This also means that before entering a case to the safety database you don’t need to first think “Should I enter this case or not because if it turns out to be a duplicate or invalid case, I will have wasted $50 of my employer’s or customer’s money which I might have to explain later?”.

Instead, you can go ahead and enter cases and experiment with the test environment. Each user of Tepsivo Safety Database gets a test environment which is identical to the production environment, except that it is meant for testing. You get unlimited access to import cases. You can try out bulk import for example to migrate data from another database or download all the cases from EudraVigilance and test how these cases will change your DSUR or the signal detection report (these reports are also always available for no additional costs).

How this can have a positive impact in your organization is that you can assign more responsibility to less-experienced drug safety specialists. Obviously, this is a variation on the theme of the second paragraph of this section, but the teaching potential of the freedom to make mistakes should not be underestimated. We are not saying you should make mistakes, or you should be sloppy, but when the users don’t have the pressure of high-cost of each mistake, there’s more room for growth and you can actually improve the quality of your data entry.

Relieving the cost-pressure also supports timeliness of the adverse event data entry process because the cases will be entered more quickly to the safety database without first checking and double-checking with the colleagues. The cases will be in the safety database in an earlier phase without delay, making resources management and time estimation easier. The time spent on discussions whether a case should be added to the database or not is reduced.

Conclusion

Counting the number of cases and the number of user licenses is an easy way to generate a price for a safety database, but it easily becomes very expensive to the customer when one or both of those parameters grows. And often these two parameters grow hand-in-hand because more cases require more people to process them.

The obvious benefit of not having to pay for users and cases is the price. Tepsivo Safety Database is significantly more affordable than the competitor safety databases. This is especially true for those organizations that have a large number of adverse event reports or a large number of users. The benefits to the PV processes come from this lower and more predictable price: more users can be added to the safety database streamlining the case entry, review, medical review, quality control and submission processes and improving the oversight of the adverse drug reaction case management process.

Being able to add cases without dreading the additional costs or the need to “overwrite” cases allows you to empower your junior drug safety specialists to enter cases directly to the safety database without first consulting with their seniors. Any revisions required will be of course free, as they should be.

Being able to add an unlimited number of cases and being able to test out things with different combinations of data in the test environment makes the preparation of aggregate reports much smoother and can improve the signal detection capabilities of your organization.