Epistem specialises in providing innovative solutions to complex problems. Our team of experts are dedicated to developing and implementing cutting-edge research models and analytical platforms to uncover insights that drive positive change. We offer a range of services, in areas from organoid screening platforms through to clinical biomarkers.
We pride ourselves on our commitment to excellence and our ability to tackle complex challenges in the biotech industry. Whether it is conducting research studies or analysing complex data sets, we have the expertise to help our clients achieve their goals. At Epistem, we are committed to supporting our clients and driving advancements in the field of biotechnology.
Epistem strives to meet and exceed customer expectations, and applicable regulatory requirements standards and guidelines. Our Quality Management System applies companywide and is designed to reflect industry best practices for clinical and non-clinical studies.
The Histology, Immunohistochemistry (and associated Image Analysis) and Pharmacogenomics laboratories are accredited to Good Clinical Laboratory Practice and also operate in accordance with:
- ICH GCP
-Clinical Trials Regulation EU No 536/2014 of the European Parliament and of the Council or 16th April 2014 on Clinical Trials on Medicinal Products for Human use, and repealing Directive 2001/20/EC
- EMA Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples
The compliance of our operations with the GCLP guidelines has been repeatedly assessed and confirmed by an independent company, Qualogy Ltd, since 2010, in addition to regular Sponsor audits.
Our GCLP certificate is available to view in Downloads.