--- title: Non-Clinical description: Discover Biomedion's non-clinical services for preclinical research, toxicology, and safety. Streamline your non-clinical development with our solutions. --- [![biomedion-logo-2020](https://www.biomedion.com/hs-fs/hubfs/biomedion-logo-2020.png?width=898&height=142&name=biomedion-logo-2020.png)](https://www.biomedion.com/en/?hsLang=en) [![biomedion - connecting the dots in life sciences](https://www.biomedion.com/hs-fs/hubfs/biomedion-logo-2020.png?width=898&height=142&name=biomedion-logo-2020.png) biomedion-logo-2020](https://www.biomedion.com/en/?hsLang=en) ![biomedion - connecting the dots in life sciences](https://www.biomedion.com/hubfs/biomedion-logo-2020.png) - [Products](https://www.biomedion.com/en/) - [Watcher 2.x](https://www.biomedion.com/watcher-2.x-the-proven-classic-for-gxp-compliant-long-term-archiving) - [Professional Services](https://www.biomedion.com/en/biomedion-professional-services) - [Raw Data Archiving](https://www.biomedion.com/en/raw-data-archiving) - [Pharma](https://www.biomedion.com/en/pharma) - [Biotech](https://www.biomedion.com/en/biotech) - [Health Science](https://www.biomedion.com/en/healthscience) - [Business Cases](https://www.biomedion.com/en/business-cases) - [Drug discovery](https://www.biomedion.com/en/drug-discovery) - [Non-Clinical](https://www.biomedion.com/en/non-clinical) - [Company](https://www.biomedion.com/en/company) - [Contact](https://www.biomedion.com/en/contact) Search Site [Connect With Us!](https://www.biomedion.com/en/contact?hsLang=en) BUSINESS CASE # Data integrity for non-clinical documentation ## From probability to success  An optimized non-clinical process is a key factor in clinical development's eventual success. For researchers, data analysts, project/vendor managers, and report writers, it's vital to stay on top of the documentation throughout the process and provide the necessary later phase deliverables for the eTMF. By staying organized, professional and diligent, these researchers will be helping to ensure that the drug development process is conducted to the highest standards. The non-clinical (or pre-clinical) development phase primarily aims to identify which candidate therapy has the greatest probability of success, assess its safety, and build solid scientific foundations before it comes to testing humans. The non-clinical development process starts in parallel with research activities, and non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic and toxicokinetic characteristics of drug candidates. Data analysts, project and vendor managers, and report writers need to stay on top of all documentation along the process and need to deliver in later phases and into the eTMF for further reference. - Non-clinical / Pre-clinical Project Management - Planning and Tracking along Drug Development Plans - Management, documentation and reporting of non-clinical programs, projects, studies (GLP) e.g. ADME, PK/TK & Tox, including CRO selection - Pharmacokinetics and Toxicokinetics (PK/TK) (GLP) Preparation of Non-clinical Regulatory Documentation & Reports (IND, IMPD, IB) - Non-clinical (Preclinical) Process Consultancy ## Business Cases where Watcher and biomedion facilitate core processes ![Formycon Case Study](https://26577795.fs1.hubspotusercontent-eu1.net/hubfs/26577795/website-featured-images/AdobeStock_332233520_TIF.jpg) ### GxP-compliant Archiving at Formycon Therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities - this is the main focus of Formycon AG. Their goal was to enhance their data integrity and process automation. A key driver of this project was the need to meet stringent regulatory requirements, ensure seamless device integration, and establish a future-ready data management system.  Read story ![Data Archiving in Drug Discorvery](https://26577795.fs1.hubspotusercontent-eu1.net/hubfs/26577795/website-featured-images/data%20cube.png) ### Raw data archiving in Drug Discovery It is essential for compliance with Good Laboratory Practices regulations that a clear understanding of RAW DATA is established and maintained in laboratory records, as RAW DATA is found in various formats and versions in a large number of laboratory devices, LIMS, and quality management systems. Professional handling and full traceability of RAW DATA throughout its life cycle are crucial for lab control and overall compliance in the drug development process. Read story ## More services ### From validation to technical support ![validation](https://f.hubspotusercontent40.net/hubfs/8124098/Images/services-details-prox-page.jpg) ### Computer System Validation We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits. **HIGHLIGHTS** - Validation Plan - Risk Analysis - Traceability Matrix - Test Plans - Test Protocols - Test Reports - Much more! Discover our Validation Services ![consulting-service](https://f.hubspotusercontent40.net/hubfs/8124098/Images/prox-consulting-service.jpg) ### Regulatory Operations Services The team at biomedion has extensive and diverse submission experience and is ready to assist with your specific needs. We specialize in the planning, processing and submission of original and lifecycle submissions to Health Authorities. We are submission and eCTD subject matter experts and offer flexible and efficient support for all stages of a regulatory application.  **HIGHLIGHTS** - Original Applications - Lifecycle Applications - Promotional Materials Submission - Submission Planning - Templates and Formatting Services for Regulatory Compliance ![maintenance-service](https://f.hubspotusercontent40.net/hubfs/8124098/Images/services_04.jpeg) ### Technical Consulting We advise you on the use of our solutions, make the necessary configurations for them or develop adaptations, e.g. for the integration of other products. In doing so, we work closely with our colleagues in the computer system validation department. **HIGHLIGHTS** - Configuration - Workflows - System integration - Security - GDPR Our professional Solutions #### Not sure what you need? [Get in touch](https://www.biomedion.com/en/get-consultation?hsLang=en) [![biomedion-logo](https://26577795.fs1.hubspotusercontent-eu1.net/hubfs/26577795/logos/biomedion-logo-2020.png)](https://www.biomedion.com/?hsLang=en) At biomedion GmbH, we are dedicated to the **secure and GxP-compliant long-term** **archiving of scientific data**. Our strategic focus is on the **"Watcher" product family** as the central brand for GxP-compliant data archiving. [linkedin-in](https://www.linkedin.com/company/biomedion/) [youtube](https://www.youtube.com/channel/UCLRBLZvHFoc5YzgyYiI9Ycw) [podcast](https://daten-doku-digital.podigee.io/) - [Watcher 2.x](https://www.biomedion.com/watcher-2.x-the-proven-classic-for-gxp-compliant-long-term-archiving) - [Services](https://www.biomedion.com/en/biomedion-professional-services) - [Customer Support](https://support.portal.biomedion.com/servicedesk/customer/user/login?destination=portals) - Connect With Us! - [Contact (Company)](https://www.biomedion.com/en/contact) - [Get Consultation](https://www.biomedion.com/en/get-consultation) - [Get a Quote today](https://www.biomedion.com/en/get-a-quote-today) ![667_RGB](https://www.biomedion.com/hs-fs/hubfs/Footer/667_RGB.png?width=140&height=140&name=667_RGB.png) biomedion GmbH is certified according to ISO/IEC 27001:2022 for secure and compliant data management and archiving solutions in highly regulated environments. Certificate Registration No. 44 121 241800; Audit Report No. 35411490   ![ISO_weiss](https://www.biomedion.com/hs-fs/hubfs/ISO_weiss.png?width=150&height=150&name=ISO_weiss.png) biomedion GmbH is certified according to DIN EN ISO 9001:2015 for providing on- premises and cloud-based data archiving solutions and raw-data archiving services. Certificate Registration No. 44 100 241800; Audit Report No. 3538 1557               © 2026 biomedion GmbH - [Privacy Policy](https://www.biomedion.com/en/privacy-statement) - [Imprint](https://www.biomedion.com/en/imprint)