In our previous blog, we looked at ways how to automate the case intake with existing automation and artificial intelligence technologies such as speech-to-text, natural language processing, and translation tools.

Here, we look at how case intake and all other aspects of case processing can be covered with one pharmacovigilance software: Tepsivo Platform.

Why isn’t automation used more in pharmacovigilance?

There are three main reasons why pharmacovigilance software and different automation tools are not yet used in the industry to their fullest:

• It is cheaper to offshore the activities to a country with low-cost labor than to use the pharmacovigilance software sold by most companies
• Many companies fear that introducing a new computerized system for pharmacovigilance would be a major validation task that would take months
• There aren’t any pharmacovigilance solutions available that could cover all the aspects of pharmacovigilance and also take care of the automation

Tepsivo Platform is pre-validated software that has been configured to cover all pharmacovigilance processes. The system is easily scalable, and our team is adding new features to the system and updating the validation package on a daily basis.

When you manage your pharmacovigilance processes through Tepsivo Platform, you will see immediate process efficiencies. The current standard of pharmacovigilance work still includes steps such as sending reconciliation and notification emails, tracking information in Excel, performing duplicate checks, archiving PDF copies of emails on SharePoint, and many other mundane administrative tasks.

With our modern pharmacovigilance software, you can leave all these steps in the past and let the automation take care of it.

Why should you automate case processing?

For a pharmacovigilance expert, talking about automation of case processing may seem limited, because they know that there is much more to pharmacovigilance than just the adverse event reports. The reason why industry is so keen on automating intake, management, and submission of ICSRs is because, if done manually and at large scale (and with inefficient processes), these activities can be a significant portion of the pharmacovigilance budget.

We covered this topic in more detail in our previous blog about automation and AI in case processing.

How can Tepsivo Platform help you?

Tepsivo Platform is pharmacovigilance software developed for the purpose of centralizing all (truly all) pharmacovigilance activities in one place. Case intake, processing, and reporting is just one aspect of it. But thanks to the modern database structure at the core of our platform, the data can be then reused for the automation of aggregate reports, signal detection, reconciliation, and reporting.

If the data acquisition can be done directly within the platform, case booking, acknowledgement, duplicate check etc. can be fully or partially automated. With Tepsivo Platform, the cases can be received through an online form, via an application for registered users, through automated email intake, or by connecting the platform to your existing case intake / data entry tools using API.

Safety Reporting module of Tepsivo Platform takes care of the administrative work

Safety Reporting module of Tepsivo Platform takes care of the administrative work

Unlimited number of users with one license

With one license you can register an unlimited number of users to the platform, ensuring that there are no additional costs for you even if all your staff is using the platform (that is the sales side of us talking).

The monthly fee of Tepsivo Platform is not affected by the number of users. You can add all your relevant staff, contractors, and SDEA partners to the platform. You do not have to have different systems for the Global and Local functions of your organization.

This reduces your need for local tracking and structuring, deduplication, and reconciliation. Tepsivo Platform compiles and sends automatic reconciliation reports to those external parties who you do not want to have access to the platform.

Case intake with Tepsivo Platform

Workflow is half the job

Ensuring a positive risk-benefit profile is the reason for collecting safety reports, assessing the safety information, and sending ICSRs and SUSARs to the authorities. This is a legal requirement. But how you do all this is mainly up to you to decide, all the way up to the end result that’s standardized (E2B / CIOMS report submitted to a certain place within certain timeline). Unsurprisingly, some companies are more efficient than others in their process. Companies already using the Tepsivo Platform are likely most efficient of all.

With Tepsivo Platform, all safety cases are saved into a database that is used for further case processing steps. Your case processing team is automatically notified of all new cases. The workflow management functionalities of the Safety Reporting module ensure that additional emailing is not required to prioritize and assign tasks. Tepsivo Platform uses modern database technology which means that all documents related to the case can be attached to the record and no additional tracking and archiving is required.

When it is time for inspection

All activities in the Tepsivo Platform are automatically recorded in an audit log and key performance indicators (KPI) are logged to a compliance tracker. The platform shows the KPIs on a dashboard and sends regular compliance reports.

The data entered into the platform can easily be filtered and exported to meet the inspectors document requests. It is also possible to provide the auditors read-only access to the system to demonstrate the transparent and compliant way of working.

Sounds too good to be true

It sure does. It is after all a completely new and currently unique system in a market that has been so slow to modernize and still largely heavily depends on manual labor.

But it’s time to leave that in the past and revamp the industry with an innovative take on how to perform all PV activities.

We don’t claim our system is perfect. There are still many features we plan to add, and we are closely working with our customers and partners to polish the features of the platform to continuously improve it. These improvements come at no additional cost or burden to you but ensure that you do not have to worry about being left with an out-dated pharmacovigilance software that could be a compliance hazard.

If you are interested to see and try out Tepsivo Platform, send us a message and we can quickly arrange a demo and a trial for you.