January 19, 2021 – This Xybion client is one of the world’s most powerful research and teaching institutions, and one of the top recipients of NIH funding in the US. They focus on the development of next-generation gene transfer vectors and their application in the treatment of a variety of acquired and inherited diseases. Their Gene Therapy Program has decided to partner with Xybion to implement the gold standard preclinical digital lab execution system (Pristima XD) to manage their studies end-to-end through a single software platform. They conduct end-to-end drug discovery and preclinical studies. The lab process execution and data management are a critical part of their research, and the digitized processes will make GLP studies more efficient, improve compliance with regulatory needs and help manage intellectual assets better.
The Xybion solution includes protocol management, study management, data management, quality management, document management, people management, lab inventory, and instrument management in a single platform-based solution.
Xybion helped them with the end-to-end business process definition, implementation of software, training, and change management. This is a Software as a Service (SaaS) based implementation.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.