Heading a team responsible for clinical operations systems.

Lech Garus is attending the DS&AI F2F in Madrid 05.2023. Lech works in the system support as the Senior Systems Manager. Lech comes from Poland and lives in Warsaw. Lech loves paragliding and bread baking.

Part of the Clinical Trial Technology and strategy group. Bringing new technology and services to our organisation

We met at DS&AI Madrid meeting. I was the the English bloke who works in clinical trials.

Collaborations with external partners may lead to joint legal rights for compounds and data, which may restrict reusage in other projects. With the increasing number of collaborations at Bayer and with advancing time, memories of the project details fade, and reconstruction of the status will be nearly impossible. Therefore, we aim for a system to document the role of compounds, which will facilitate decisions on further usage in other collaborations. For more information contact: Miriam Wollenhaupt. Images taken from Microsoft Office free for use pictograms.

Scientific work in Pharma R&D requires a reliable high-quality body of data and knowledge. Bayer Pharma R&D has an extremely large amount of scientific data. The use of a Data Catalog significantly improves the findability of data and serves as a key pillar in the implementation of a comprehensive data strategy.

Recent focus has been on streamlining and optimizing the clinical operations system landscape. To support the initiative, our key business capabilities related to clinical operations are consolidated on one core platform: Gemstone. Gemstone is a Software as a Service provided by Veeva and contains modules of their Vault Clinical suite. Where possible the system remains as close to "out of the box" as possible to align with industry standards and to reduce the complexity for the 3 general releases provided by Veeva. eTMF, Startup, Monitoring, Site Connect, Feasibility components are already live. The latest Gemstone „Ruby“ went live over Eastern (April 23). IRIS is now retired, and Issue Management, Monitoring, and Study Risk Management and Study Training are available in Gemstone with more capabilities to come. Gemstone interfaces with over 50 systems and is closely integrated with RAVE, RAVEN, BRAVE and other systems. Gemstone provides a modern technology foundation with API capability, allowing connection via the Integration Hub, a bespoke PaaS solution with a unified data integration layer. As not all systems are as advanced, the Integration Hub provides a database facade that allows backward compatibility to cater to those legacy systems.