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Innovation Impulses
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Latest Insights
up to data Blog
Discover Innovation Impulses
and Latest Insights
Explore how advanced technology is reshaping clinical trial data management.
The up to data blog examines industry trends in laboratory technology, artificial intelligence, data automation, research efficiency, and quality improvement. Follow insights on how emerging technologies are driving precision medicine forward and shortening the pathway from research to effective therapies.
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Current
AI in GxP Environments: Context-First Approach
03/26/2025Blog Leveraging AI in GxP Environments: A Context-First Approach to Bioanalytical Data Management In regulated bioanalytical laboratories, the promise of artificial intelligence has often seemed at odds with the stringent requirements of GxP compliance. Traditional approaches to AI implementation face significant hurdles: data privacy concerns, validation challenges, and the complexity of maintaining compliance when using… -
Knowledge
CRO-Sponsor Collaboration: Digital Risk Mitigation
08/14/2025Blog Optimizing CRO-Sponsor Collaboration: Mitigating Risks in Bioanalytical Study Reporting Manual processes in bioanalytical studies jeopardise efficiency, data integrity, and compliance – especially under the strict ICH M10 requirements. This article shows how digital platforms like StudyGen 360 leverage centralised data access, real-time collaboration, and automated workflows to minimise errors, accelerate studies, and future-proof CRO–sponsor relationships. Why… -
Knowledge
Context-First AI Approach for CROs | Multi-Run Assay Control
06/25/2025Blog The Critical Role of Multi-Run Assay Control in Bioanalytical Research: A Context-First AI Approach for Contract Research Organizations (CROs) In bioanalytical research, precise and reliable data is of the utmost importance. This article examines the necessity of robust quality control (QC) systems with a specific focus on multi-run assay control procedures for Contract Research… -
Success Story
Digital Transformation INQA Success Story
03/24/2025Blog The Challenge of Digital Transformation: How up to data GmbH Shapes Future-oriented Change The digital transformation and the changes associated represent a particular challenge for medium-sized companies. up to data GmbH meets this challenge with a sophisticated concept and professional support through the INQA coaching program, an initiative coordinated by the Federal Ministry of… -
Knowledge
Standardized Multi-Run Assay Control Guide Recording
03/10/2025Blog Enabling Standardized Multi-Run Assay Control: Key Insights for Bioanalytical Labs In an increasingly complex regulatory environment, bioanalytical laboratories face growing challenges in maintaining consistent assay performance across long-running studies. A recent webinar led by Norbert Bittner, CEO of up to data, provided comprehensive insights into implementing standardized multi-run assay-controls and highlighted effective strategies for… -
Success Story
Lundbeck ICH M10 StudyReporter Implementation Case Study
06/19/2024Blog 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)… -
Success Story
UCB LabWare LIMS Stability Reporting Case Study
04/17/2024Blog UCB opted for StudyReporter on Labware LIMS as Stability Reporting Solution 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. Challenge UCB is running its stability operations QA… -
Success Story
Biotest Stability Data Automation Case Study
04/15/2024Blog End-to-End Management of SAP Stability Data Learn how our reference customer Biotest AG in Dreieich, Germany, has improved reporting performance. Biotest AG developed its labour-intensive manual stability reporting process by implementing StudyReporter Stability, cutting approval times and gaining a competitive edge through automated, regulatory-compliant report generation. Discover how this German biotech company streamlined their… -
Success Story
Worldwide Clinical Trials Perform Bioanalytical Study Reports Case Study
06/19/2023Blog Worldwide Clinical Trials Selected StudyGen 360, up to data´s Reporting Solution, to Perform Bioanalytical Study Reports up to data, a long-standing supplier of report generation software for regulatory purposes, announces that it has been selected by Worldwide Clinical Trials, Inc. (Worldwide), a leading full-service global contract research organization (CRO) that works in partnership with… -
Success Story
Boehringer Ingelheim Rapid StudyReporter Implementation Case Study
06/29/2022Blog Extremely Rapid Implementation of Regulatory Bioanalytical Reporting Learn how Boehringer Ingelheim successfully converted their bioanalytical reports to automated reporting in a very short time, and the challenges the world’s leading pharmaceutical company faced. Executive Summary The StudyReporter Bioanalytics project was implemented from October 2009 to February 2010 and was integrated into Boehringer Ingelheim’s software…