arivis AG
BigImage Data and Regulatory, Quality, Compliance (RQC) Management

Today, ever-increasing technical improvements, along with market changes and regulatory compliance issues are transforming the pharmaceutical and life sciences industry. Meanwhile, the use of multi-dimensional, (super) high resolution big image data or whole slide imaging sets is enabling new discoveries in life sciences, applied science and health care. Additionally, molecular biologists, neuroscientists, and drug development specialists, etc are more and more demanding innovative technologies to manage the data explosion in the biomedical image space. With a specialized but comprehensive product portfolio arivis AG, based in Munich, Germany provides big image data and RQC-software to cover the whole research and RQC value added chain in the life science industry.

arivis Imaging Science software enables users to visualize, explore, analyze, distribute and manage multi-dimensional image data sets from 2D to 5D of nearly unlimited size on standard PC’s and laptops. “Our web imaging technology assists organizations globally to handle extremely large biomedical 3D images in a secure manner, without any kind of plug-ins in a standard web browser,” says Andreas Suchanek, Founder and CEO, arivis AG.

Leveraging cloud technology, the arivis RQC-platform, Clireo, provides various validated modules for all sizes of pharmaceutical companies. Clireo’s eTMF (electronic Trial Master File) module allows businesses and their external users to collaboratively, transparently, and securely manage review, audit, inspect, and search TMF documentation from any location around the world. The second module, Clireo Submission, helps organizations to manage their global regulatory activities. The third module provides comprehensive regulatory information management which creates a complete platform that includes submission planning, correspondence tracking, and xEVMPD/IDMP management. Lastly, Clireo electronic Management of Promotional Materials (eMPM) provides an integrated fully featured solution that supports compliance of promotional materials review and approval per global health authority requirements.

Further enhancing the company’s product suite, arivis acquired BioMedion - a company specialized on compliant electronic content management (ECM), electronic quality management System (eQMS) and training management solutions for the pharmaceutical and other 21 CFR Part 11 related industries.

Our web imaging technology assists organizations globally to handle extremely large biomedical 3D images in a secure manner, without any kind of plug-ins in a standard web browser

BioMedion software is tightly integrated and highly configurable, beginning with workflows, forms, electronic signatures and reporting. BioMedion provides official guidance on regulatory, organizational, and IT issues, but also offers services that secure organization’s historical raw data which can be directly reprocessed without any laborious recreation procedures.

Since its inception, the company has been empowering various life-science, pharma and academic organizations with their ground-breaking product portfolio to handle data explosion as well as regulatory and compliance burdens. Together with the Harvard Center for Biological Imaging (HCBI) arivis received the Microsoft Life Science Award. Dr. Doug Richardson, Director of HCBI says: “arivis software is the only application available to stitch and visualize these amounts of data in reasonable time. Stitching of a 1 TB dataset lasts about 1-2 hours, visualization can be done completely interactively on a normal desktop PC. So, our lightsheet microscope and arivis software gives us a completely new tool for understanding the connectome of the mammalian nervous system. This will lead us to a breakthrough in neuronal sciences.” Another example for the competitive position of arivis is BioMedion’s software for the management of electronic raw data for more than ten years. One of the largest customers herewith meanwhile supports six development/production sites with in total several hundred laboratory instruments and several thousand users in GxP and R&D environments in an FDA compliant mode.

Driven by continuous innovation, creativity, and experience, the company plans on growing and upgrading their imaging technologies to the next level through virtual or augmented reality providing new insights into your big image data.