Quality Commitment

The Robertson Centre for Biostatistics is committed to the provision of quality research services and aims to provide high quality data and statistical reporting to its clients and collaborators, developing its technology continually in order to provide innovative software systems.  It offers a flexibility of approach and commitment to excellence, with changing needs accommodated and managed.

All clinical trials are managed to the highest standards in accordance ICH Good Clinical Practice, The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No 1031), the European Union Clinical Trials Directive 2001/20/EC, the ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials E9 and all other applicable industry legal and regulatory guidelines. 

The Centre is certified for ISO 9001:2008 for its quality systems, and has TickIT certification for its software development.  The Centre is audited every six months by the British Standards in Industry (BSI) and regularly conducts its own internal audits, carried out by BSI-trained internal auditors.  It has also been the subject of several successful regulatory inspections conducted by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).  It is regularly audited by its sponsors and clients both prior to and during the course of studies.

The Centre has extensive experience of managing data in the context of privacy and data protection legislation, including the Data Protection Act 1998 and EU Data Protection Directive 95/46/EC.  Extensive data security procedures are in place including firewall protection, virus detection, daily backups, routine transaction logging, restricted access, and on-site and off-site fire-proof storage of backups.