knowledge

Implementation of ICH M10 Requirements included in StudyReporter Upgrade

Learn how Department of LCMS Bioanalysis at H. Lundbeck A/S has improved reporting performance by upgrading to up to data’s StudyGen 360 Reporter Bioanalytics 3.6 and implementing new regulatory ICH M10 standards within one project.

Situation

Lundbeck selected StudyGen 360 Reporter (also known as StudyReporter) from up to data in 2015 for regulatory bioanalytical reporting after an extensive evaluation process involving several software providers.

StudyReporter serves as an add-on reporting solution based on Thermo Scientific™ Watson LIMS™ (Thermo Watson). In Lundbecks implementation, it generates regulatory compliant reports for BioA & toxicokinetics appendices, reporting of BioA data from clinical trials, and method validation, including long-term stability reports. The solution features a direct interface to Thermo Watson. This, in combination with up to data’s table-protection functionality, enables Lundbeck to gather data from the Watson database and produce various bioanalytical reports without any intermediary manual steps or data rechecks. As such, end-to-end data integrity is fully implemented in a seamless manner. Consequently, the process of GxP report creation at Lundbeck is now completely automated.

In order to comply with the GAMP 5 guideline and ensure data integrity that allows for seamless data flow in a GxP environment, Lundbeck performed the appropriate part of the CSV package of the installation, processing, and each report template implemented.

Achievements

• Realization of regulatory reporting requirements with regards to ICH M10 guidelines
• Revision of bioanalytical tables based on current standards
• Utilization of the Thermo Scientific™ Watson LIMS™ 7.6.1 features
• StudyReporter Upgrade 3.2 to 3.6

Project Process

As the project was primarily focused on implementing regulatory guidelines, the ultimate goal was to enhance the final report output. The initial step involved upgrading Thermo Watson, which was followed by the required validation process. The second step was to upgrade StudyReporter, which was achieved in conjunction with the final publication of the ICH M10 guidelines.

The main focus of the project was to adjust the existing tables in line with the updated regulatory requirements. In order to achieve this goal, a thorough review, evaluation, and modification of all relevant reports was conducted. As a result, the latest regulatory updates, including the Study Summary and Matrix Effect Tables were also incorporated.

Already since 2019, up to data integrated the ICH M10 standards into their table portfolio, enabling Lundbeck to benefit from a wide array of up-to-date regulatory compliant tables and reports. Hence, the implementation of all changes was rapid and effortless, from a reporting standpoint.

Results

Changes in laboratory workflows and processes can be challenging, particularly in GxP environments. However, with a comprehensive plan and strategic partnerships, efficiency can be achieved. Thanks to Lundbeck’s forward-thinking management, their project successfully integrated the latest changes to the ICH M10 guidelines in 2021.

Based on Thermo Scientific™ Watson LIMS™ 7.6 and StudyReporter 3.6, Lundbeck is well-equipped to face future challenges in bioanalysis as it meets all regulatory changes associated with the implementation of ICH M10 guidelines.

Benefits of our Services

• Fully implementing regulatory requirements based on ICH M10 guidelines
• Incorporating Thermo Watson improvements into reports
• Providing recent bioanalytical reports and tables
• Streamlining the process of creating submission-ready reports
• Delivering standardized, future-proof study reports

Next steps

As part of an overall digitalization strategy, Lundbeck LCMS Bioanalysis is aiming to capture all bioanalytical and toxicokinetic data in a digital format.

Hence, as part of the next upgrade it is planned to implement the CDISC SEND report format (for PC and PP domain) that enables direct output of study data in SEND format without any further reformatting or QC steps.

Customer Feedback

“I want to thank the team at up to data for their great work on this project. Since they have longtime experience on Watson data management and are specialized in the highly regulated bioanalytical environments, we can trust on their expertise. During the project we had an excellent cooperation, and the team was eager to make improvements rather than just recreate the wheel.” Morten Kall, Director of Department of LCMS Bioanalysis

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our approximately 5,400 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy.