Knowledge

Blog 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…

Blog 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…

Blog 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…