Sympto
Is your pharmacovigilance department ready for a better drug safety workflow?

In the life-science industry, drug safety regulations are getting more complex every year. And the rate at which the amount of data has grown has challenged organizations to search for new solutions.

Since safety data must be accurate from intake to reporting, legacy systems with fragmented data across multiple locations and lifecycles are challenging to manage. And many companies face a daily need for data reconciliation. Rather than providing time for scientific judgment to analyze potential drug safety signals, a lot of their time revolves around making sure the processed data is correct.

But sourcing a suitable safety database is a long and complex process. And with smaller volumes of cases, pharmaceutical manufacturers and CROs ask themselves whether it is feasible to procure a safety database for their teams.

A Cloud Solution for Pharmacovigilance

Eight years ago, a contract research organization in Zagreb faced a similar dilemma. Marti Farm was expanding its team of niche specialists in pharmacovigilance but could not sustain paper-based workflows. Marti Farm's pharmacovigilance department required a simple, user-friendly, cost-effective system that would process PV cases and handle multiple users, multiple clients, and communicate with various agencies. To address their needs, the company—with its team of PV professionals—created a unique cloud database solution called Sympto® that could cover all regulatory requirements, serve as a collaborative team platform, and essentially give PV experts tools to focus on drug safety.

Having undergone constant improvement and innovations over six years by a joint team of PV experts and software engineers, Sympto® has emerged as a simple, user-friendly, and cost-effective pharmacovigilance system. Marti Farm has incorporated complex standards such as ICH E2B R3 and R2 into the platform while also safeguarding each client's confidentiality.

Harmonized and validated according to the industry standards such as GAMP, 21 CFR Part 11, and ICH, Sympto® is one of the most cost-effective platforms that helps companies achieve complete compliance. To improve the user experience, you can access Sympto® from any web browser or mobile device too.

Also, as a real-time team management system, Sympto's intuitive dashboard serves as a control room for teams' pharmacovigilance operations.

Here, PV associates can find reminders for all pending tasks, create customizable notifications, and use an in-case chat section to address particular ICSR workflow. There is a notification system that warns the team when it's close to non-compliance as well. "We have made the PV system complete with additional modules, such as the Literature module, Activity reports generator, and Clinical trials module," says Ena Bulović, a Senior Pharmacovigilance associate.

With Sympto®, case delivery and safety reports are automated and in line with the requirements of regulatory bodies such as the EMA and the FDA. When it comes to pharmacovigilance, Sympto® adheres to every regulation, directive, and EMA's GVP modules, such that the processing of individual cases is done with the utmost safety. The multi-client ICSR module provides centralized reaction management and exchages data with third parties through the gateway system. "We can process safety information, ICSRs, and more for multiple clients within the same environment, but we maintain the confidentiality between those clients," says Željko Kranjčec, Chief technology officer.

User-Friendly and Customer-Centric

If users need help getting acclimated to the solution, Marti Farm offers constant customer support, with PV and IT experts on the line, ready to assist when necessary. The support system also includes user training and re-education modules. Users are delighted with Sympto's ability to collect, analyze and report all safety information under one roof, allowing them to prioritize and divide the workload between their team members. A swift notification system is in place to ensure that clients follow regulations and alert them before breaching compliance. Since the solution is cloud-based, clients can use the solution from anywhere globally with no fear of overlooking essential tasks or deadlines.

Sympto is a collaborative cloud system that integrates pharmacovigilance data processing from intake to gateway submissions and gives PV teams a single source of truth to analyze drug safety.