A Life Sciences case study from the heart of Europe

Clients partner with Clarivate consultants for many reasons, including strategic perspective, additional skills, complementary data sets and therapy expertise.

In the research and development space, we help companies advance their drug discovery, preclinical proof-of-concept, and regulatory activities.  Clarivate’s translational science expertise, regulatory and commercial experts and assets combine to complement client teams in generating long term value.

I’m therefore particularly proud of this newly published case study where Gedeon Richter and Clarivate worked closely to transform regulatory workflow, connect data and improve decision making.

Our client is a major pharmaceutical company headquartered in Budapest, Hungary, with an expanding presence in Western Europe, Mainland China, Latin America and Australia. Its product portfolio covers many important therapeutic areas, including women’s healthcare, central nervous system and cardiovascular health.

53% of pharma CEOs report regulatory changes as a top disruptive trend*

Gedeon Richter had a need to streamline regulatory monitoring and impact assessments. Each day, thousands of regulatory and industry-related documents are released from different regions and companies all over the world. Before partnering with Clarivate, teams would spend hours manually triaging these regulatory documents to identify and communicate impacts across their organization.

This required a significant amount of time to sift through multiple regulatory intelligence sources to identify and locate essential data. Gedeon Richter staff would travel to the sites of EMA (European Medicines Agency), FDA (Federal Drug Administration) and other regulatory authorities to manually review updates in regulations or guidelines. These documents would be downloaded and sent manually via email to subject matter experts.

Gedeon Richter is one of the earliest subscribers to the Clarivate Regulatory Intelligence Tracking Application, an industry leading solution and companion to Cortellis Regulatory Intelligence™.  This end-to-end solution helps organizations manage regulatory intelligence by providing a single source of truth, unifying and making that data more actionable.  Our consultants have helped empower professionals at Gedeon Richter to think and act more strategically by providing:

  • Customizable dashboards that deliver the regulatory update data specific to regions and topics of interest
  • Solutions powered by AI that automates the daily processing of new regulations and legislation
  • A source for all departments to complete and view impact assessments.
  • A notification and alerting system that keeps their experts up to date on the latest regulatory requirements around the world
  • A searchable storage solution that consolidates regulatory updates

The impact of a trusted partnership

Now, with unified data sources from Clarivate, Gedeon Richter has more visibility into regulatory changes and can reinvest time on higher value activities such as actions and impact assessments.

Technology and regulatory consultants from Clarivate provided full support during Gedeon Richter’s transition into the tracking application.

“Clarivate has been very approachable and responsive to taking our business needs into consideration when working with the tracking application. We are now able to efficiently triage and manage our regulatory alerts, send out newsletters with ease, and so much more!”

Kinga Pallay, Regulatory Intelligence Expert, Gedeon Richter

Our worldwide roster of clients can call upon a 300-strong team of practice leaders, therapy area specialists, data scientists, industry experts and analysts who take the time to understand client needs so that we can co-create transformative solutions like this Gedeon Richter example.

If you would like to discuss your 2024 plans with any of our R&D, commercialization or technology enablement teams, please connect with our experts here.

*Source: https://www.nature.com/articles/d41573-022-00001-9