StudyGen 360 Support

Let’s Create
a Smarter Study
Data Management


Our support team is available to ensure the smooth and efficient operation of your StudyGen 360 solution – whether it’s technical questions, troubleshooting, or optimization recommendations.

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Support StudyGen 360

Let’s Create a Smarter Study
Data Management

Supportcenter

Our support team is available to ensure the smooth and efficient operation of your StudyGen 360 solution – whether it’s technical questions, troubleshooting, or optimization recommendations.

Got Questions?
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StudyGen 360 Platform

The system is great because it can support both large corporate laboratories and small laboratory units. It can be used in on-premise and cloud environments, making it very flexible. Its architecture can be adapted to different organizational structures for the pharmaceutical, CRO, and biotech markets, as well as to various study requirements in the areas of bioanalytics, immunogenicity, and stability.

The Watson-integrated solution is available as an on-premise deployment. For non-Watson solutions, the system can be deployed in the cloud, including private cloud environments. It supports AWS and can be adapted for other cloud providers.

StudyGen 360 is a comprehensive clinical study data platform. It integrates data from multiple sources (LIMS, SAP, Excel, diff. databases) and provides automated GxP-compliant reporting with real-time analytics. Unlike conventional LIM-systems, it offers end-to-end data integrity from sample collection to the final study report generation.

The cloud solution offers much more flexibility in data processing and analysis compared to the on-premise version. It uses modern database technologies instead of Oracle, reducing licensing costs. The cloud platform is built around a study-centric rather than sample-centric approach, allowing for more sophisticated data analysis across studies. It also provides enhanced scalability and easier updates.

StudyGen 360 uses a modern cloud-native architecture built on AWS services. It employs Lambda functions for serverless computing, allowing automatic scaling and improved security. Data is stored in encrypted S3 buckets and Aurora databases (MySQL/PostgreSQL variant). This architecture eliminates the need for traditional server infrastructure while providing enhanced scalability and security features.

The system adheres to ICH M10 guidelines, implementing robust security features like e-signatures, restricted access controls, and comprehensive audit trails. Its configurable validation processes ensure regulatory compliance across different research environments.

Implementation usually spans one month, involving collaborative process understanding, wizard-based configuration, and strategic system setup with minimal technical complexity.

StudyGen 360 is fully 21 CFR Part 11 compliant with built-in electronic signatures, comprehensive audit trails, and data integrity controls. All processes meet FDA regulations for electronic documentation. The system maintains complete traceability through versioning and provides human-readable archiving for regulatory submissions.

Yes, StudyGen 360 offers flexible deployment options to match your needs: on-premise for complete control, cloud for scalability, hybrid for best of both worlds, or SaaS for minimal IT overhead. Our “pay-per-use” model ensures you only pay for what you actually use.

StudyGen 360 enables unprecedented transparency while maintaining separate data environments. CROs can efficiently communicate study progress and potential challenges, while sponsors gain earlier visibility into study trajectories. This reduces communication overhead, enables faster decision-making, and creates more dynamic partnerships at every trial phase.

StudyReporter

This solution provides immediate out-of-the-box functionality with approximately one month of collaborative configuration. Most customizations can be achieved through a user-friendly wizard and a varity of configuration options.

According to customer feedback, the solution saves around 70 to 80% of the total time spent on creating and reviewing reports. Although some manual tasks such as adding comments and a reduced review process are still necessary, automated data transfer, automated creation of complex tables, and the elimination of data cross-checking significantly reduce the overall effort required.

The system offers high flexibility through its experiment concept. Users can define different ways of looking at data, create interactive selection mechanisms, and implement various calculation methods. The platform supports both standardized workflows for regulated environments and more flexible approaches for research and development work. The cloud platform is particularly notable for its ability to perform variable experiments and data analysis requirements quickly and securely.

The system is being developed to support comprehensive data review across different studies and batches. It will allow comparison of chromatograms, analysis of outliers, evaluation of internal standards, and other cross-study analyses. This capability is particularly valuable for reviewing data from different sites or comparing studies over defined periods.

The system is expanding its capabilities with innovative AI features that allow users to request analyses using natural language, simplifying complex data processing. By generating code based on user requirements and facilitating report modifications through natural language instructions, the AI enhances accessibility while maintaining security by processing only data structure information rather than sensitive data. These features are scheduled for upcoming system releases and are currently in testing phase.

The system provides extensive reporting flexibility through configurable templates that adapt to different sponsor requirements. Users can modify column layouts, adjust data fields, and fine-tune number formats between decimal places and significant figures. Large datasets are handled efficiently with horizontal table splitting to maintain document readability, ensuring optimal presentation of complex data. Free text sections are available for comments and ammendments below the tables as needed.

Service Arrangements

Your StudyGen 360 Support from a Single Source

Our support service provides you with the confidence you need for the daily operation of your systems. We offer various support levels to meet your specific requirements, from standard business hours support to 24/7 availability. In addition to reactive support, we also provide proactive maintenance and regular system checks to identify and resolve potential issues before they impact your operations. Our support portfolio includes:

  • Personal Support
  • Extended Support Services
  • Upgrade Consulting
  • Response Time by Specific Arrangements

You did not find what you expected?

Supportcenter
up to data Jobs | Stylized illustration of person in pink shirt looking through binoculars with decorative leaves on transparent background
Service Arrangements

Your StudyGen 360 Support from a Single Source

Our support service provides you with the confidence you need for the daily operation of your systems. We offer various support levels to meet your specific requirements, from standard business hours support to 24/7 availability. In addition to reactive support, we also provide proactive maintenance and regular system checks to identify and resolve potential issues before they impact your operations. Our support portfolio includes:

  • Personal Support
  • Extended Support Services
  • Upgrade Consulting
  • Response Time by Specific Arrangements

You did not find what you expected?

Supportcenter
up to data Jobs | Stylized illustration of person in pink shirt looking through binoculars with decorative leaves on transparent background