Introduction
Pharmacovigilance is striving for keeping compliance with the regulatory requirements because of the increasing number of adverse events from multiple sources and the complexity of the data.
How about the advanced and integrated data technologies that improve the data collection, data consistency and operational efficiency, expediting the headways against heavy seas in the pharmacovigilance world? Doesn’t it help to prevail that challenge or at least make it easier to deal with?
On numerous occasions, the collected data is often siloed in the Safety databases where the reporting and data visualisation functionalities are constrained by complex configurations.
Because of that, limited utilisation of real-time data in analytics and reporting functions create burdensome for Pharmacovigilance business units. Typically, that burdensome may impede enjoying the exceptional value of data analytics.
Arithmos supports Life Sciences Companies in defining and implementing the right solutions to gain the maximum value from advanced analytics and generate results having a significant impact on their business performance.
Background and Challenges
Kedrion Biopharma is an international company having a presence in more than 100 countries, that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as haemophilia and immune system deficiencies.
Kedrion’s ambition is to enhance its worldwide role as a strategic partner of the national health systems of those countries which aim to become self-sufficient in the availability of plasma-derived products, also via technology transfer.
As an extension of that strategy, Kedrion decided to constitute a completely scalable and streamlined reporting capacity in pharmacovigilance that:
- grants data integrity and regulatory compliance;
- reduces internal time and effort for reports production;
- empowers final Pharmacovigilance users by enabling them with increased independence along with the activities.
Path of Success
The effective engagement model established among Arithmos and Kedrion was the key to figuring out the perfect solution fulfilling the expectations of Kedrion.
Arithmos have carried out a comprehensive analysis with its’ Safety Domain Experts and Technology Consultants associated with Kedrion’s Pharmacovigilance Team to define core business needs, the structure of information required, the Safety Database data structures and mappings, the relevant architectures in the system with selection rules.
An interactive interface and a customised dashboard have been designed by Arithmos to provide the flexibility and agility that Kedrion needed to get advanced in the reporting process of Pharmacovigilance.
A reporting platform “Kairos” was created to provide a unique user experience with a powerful and easy-access tool enabling autonomy for Kedrion over the data.
The User Interface has been set up with an advanced filter mask that allows defining:
- Ingredients
- Product
- Case Classification
- Cumulative Date Range
- Interval Date Range
Kairos, the reporting platform developed by Arithmos, helps Kedrion to create a significant business value from the advanced analysis of data by facilitating the real-time reports through a user-friendly dashboard, besides assuring regulatory compliance.
Kedrion boosted the ROI (return of investment) of the reporting platform, but how?
The high configurability of the reporting platform enabled Kedrion to implement the solution in a scalable manner, granting an immediate return of investment. The scope of the first implementation run was the PSUR Summary Tabulations.
The reporting platform Kairos, as a part of Kedrion’s Pharmacovigilance System, has been implemented and tested with a proper Validation exercise.
In the following months, the platform has been enriched by custom reporting to support regulatory inspections (a Line Listing “case level” format and a Line Listing “event level” format that can be visualised in the platform or extracted in .pdf or .xls format).
From the release, the platform is completely accessible to Kedrion Pharmacovigilance Users via the web both from PCs and devices. Arithmos maintains and supports Kedrion both from the technical (managed cloud model) and validation point of view, to guarantee the best efficiency.
Success factors and outcome
The reporting platform Kairos has been a successful solution for Kedrion Biopharma.
Through that flexible reporting platform and a smooth implementation project, Kedrion Pharmacovigilance Team:
- automated manual process steps;
- facilitated a smooth process flow and gained cost reduction;
- enhanced report data security and consistency.
The Pharmacovigilance team who uses the reporting on a day-by-day basis has been engaging with an advanced final user experience since:
- they have full and secure access to a web-based platform where safety reports can be accessed remotely;
- the platform is fully synchronised with the user’s Kairos session so that selections and section access rules are automatically applied to the generated report;
- reports can be generated on-demand with a single click directly from any sheet in the Kairos app.
As Arithmos, we are delighted to use our technology and industry knowledge to help Kedrion Biopharma deliver smart solutions for the patient journey they desire to fulfil to bring healthier and less restricted lives to people.
Want to learn more about how you can improve your reporting processes in Pharmacovigilance?
About Arithmos
Arithmos is a Business and Technology expert in Life Sciences helping pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations. We are a long-standing partner and service provider across Clinical Development, Regulatory and Compliance, Quality Management, Pharmacovigilance, and Medical Affairs domains.
Arithmos is a dynamic and fast-growing company in the process of expanding its Consulting Services among Manufacturing and Commercial Excellence in the Pharma industry.
