up to data
Sustainable solutions for managing and reporting study data at the laboratory level. This up-to-date approach enables faster decision-making, proactive safety monitoring, and seamless collaboration between research sites, sponsors, and regulatory bodies throughout the entire study lifecycle.
up to data
Conecting Study Data in a Data Driven World
Sustainable solutions for managing and reporting study data at the laboratory level. This up-to-date approach enables faster decision-making, proactive safety monitoring, and seamless collaboration between research sites, sponsors, and regulatory bodies throughout the entire study lifecycle.
Studygen 360
Managing Study Lab Data Demands Data Processing Systems
Tailored to its Unique Needs
From sample collection to the final approval document, StudyGen 360 provides a scientific data platform for creating and analyzing complex study data reports for submission purposes and beyond.
Rapid Result Access
Speed matters in regulatory submissions. Our study data platform ensures quick availability of real-time study results at any time, reducing time-to-market while maintaining quality standards.
Regulatory Compliance
Study reports must be carefully prepared to fulfill regulatory requirements. StudyGen 360 ensures data integrity and regulatory compliance while streamlining the overall documentation process.
Informed Decision Making
Transform raw lab data into actionable insights. Monitor QC metrics, throughput, sample integrity, and get study real-time insights into each phase of study.
Enhanced Sponsor-CRO Partnership
Strengthen relationships through transparent and timely lab data insights in every stage of the study . Communicate study trends and results efficiently, meeting quality criteria while fostering trust.
Automated Reporting at ANY TIME during your Study
Automated processes ensures fast and targeted reports, while end-to-end automation guarantees consistent data integrity in your study. Manual effort, especially for time-consuming regulatory reporting, is eliminated, data processing is streamlined and reports can be created at the touch of a button. This comprehensive automation reduces the risk of human error and ensures compliance with regulatory standards across all reporting requirements. The need for manual quality control data checks is eliminated, as the system continuously validates data accuracy throughout the entire process.
Rapid Result Access
Speed matters in regulatory submissions. Our study data platform ensures quick availability of real-time study results at any time, reducing time-to-market while maintaining quality standards.
Regulatory Compliance
Study reports must be carefully prepared to fulfill regulatory requirements. StudyGen 360 ensures data integrity and regulatory compliance while streamlining the overall documentation process.
Informed Decision Making
Transform raw lab data into actionable insights. Monitor QC metrics, throughput, sample integrity, and get study real-time insights into each phase of study.
Enhanced Sponsor-CRO Partnership
Strengthen relationships through transparent and timely lab data insights in every stage of the study . Communicate study trends and results efficiently, meeting quality criteria while fostering trust.
Automated Reporting at ANY TIME during your Study
Automated processes ensures fast and targeted reports, while end-to-end automation guarantees consistent data integrity in your study. Manual effort, especially for time-consuming regulatory reporting, is eliminated, data processing is streamlined and reports can be created at the touch of a button. This comprehensive automation reduces the risk of human error and ensures compliance with regulatory standards across all reporting requirements. The need for manual quality control data checks is eliminated, as the system continuously validates data accuracy throughout the entire process.
Important Note: "iStudyReporter" has been rebranded to "StudyReporter" as a part of the platform "StudyGen 360".
Relevant Industries
Large AND Small Molecules
Advanced reporting for PK/PD studies, method validation, and bioequivalence trials. Automated generation of calibration curves, dilution summaries, and statistical analyses with built-in validation checks.
Multi-Run Assay Control
Multi-run QC management with automated trend analysis, statistical process control, and real-time monitoring. Intelligent assay drift detection, outlier assessment, and run-to-run comparability with regulatory-compliant documentation.
Immunogenicity
Comprehensive immunogenicity evaluation tools with automated ADA screening, confirmatory assays, and neutralizing antibody assessments. Statistical evaluations tailored to regulatory requirements.
Stability
Dedicated stability testing workflows with automated trend analysis, shelf-life predictions, and regulatory-compliant stability reports. Real-time monitoring of critical quality parameters.
StudyGen 360 at a Glance
Smart Solutions for perfect Study Data Management.
>110K
Reports Created
>800
REport Table Configs
>30
Global Customer
>100
Projects
Norbert Bittner
CEO, up to data
For more than 30 years, we’ve helped our lab customers increase their efficiency, reduce processing time and drive growth. In doing so, we look at each project individually and deliver the right solutions for your scientific workflows.
WHAT OUR CUSTOMERS SAY
“We have yet to handle a software project that was managed as smoothly and professionally as with up to data. We were also able to introduce the process so quickly because many specific requirements are already included in the standard.”
“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.”
“StudyGen cut our report generation time by 60% and reduced review effort by 68%, saving us nearly 60 to 70 hours per month. It’s transformed our QC process—no more manual Excel work or formatting headaches.”
"The project approach and support during the project was a key factor in the successful project."
“StudyReporter Stability is easy to configure and roll out, and thus relatively inexpensive – which means that opting for an out-of-the-box solution [...] was the right decision. This is particularly evident all the way down the line when you compare StudyReporter Stability with the labor-intensive process of a customized solution.”
“iStudyReporter allow my team to focus only on scientific and added values sections when issuing a report and totally remove all activities related to the edition of the document itself (e.g. data table, trend chart).”
WHAT DRIVES US NOW
-
AI in GxP Environments: Context-First Approach
Blog Leveraging AI in GxP Environments: A Context-First Approach to Bioanalytical Data Management In regulated bioanalytical laboratories,…
