StemExpress’ Contract Bioservice Organization group, also known as Contract Research Organization (CRO), provides research and support services to pharmaceutical, biotechnological, and healthcare companies in their nonclinical and early phase stages, preclinical studies, and ongoing clinical trials. From testing new cell-based equipment during the developmental phase to organizing specific and recallable donors for clinical trials, our breadth of knowledge and scientific expertise enables us to meet clients’ needs and close the gap on time-to-market for their products.
StemExpress facilities comply with strict guidelines regarding the production, processing, and management of tissue-based cellular products to ensure the overall quality. Each facility complies with FDA CFR 1271 requirements of current Good Manufacturing Practices/Good Tissue Practices (cGMP/GTP) regulations covering human cells, tissues or tissue-based cellular products (HCT/Ps) for the use in clinical applications. The cGMP/GTP compliant facilities operate under strict, approved standard operating procedures (SOPs) and are managed using FDA CFR 1271 compliant Enterprise Resources Planning software (ERP) and Quality Management System (QMS), which is used to streamline manufacturing operations from order generation to product delivery. In addition, human tissue collection protocols are approved by the company’s Medical Director and Independent Review Board (IRB) in accordance with federal law.
As demands in human studies and advances in medical research become increasingly difficult due to soaring production costs and extensive developmental times, it is important to choose a partner that enables you to easily navigate barriers, enhance quality, and drive success in your research and clinical trials.
No matter what service we are providing, the bottom line is the quality and deliverability of your product.