Qualogy was founded in 1995, as an Independent Consultancy Company, specialising in providing expertise to organisations that are required to implement the requirements of Good Laboratory Practice and Good Clinical Practice.
The company was founded by Tim Stiles, who has worked within the regulatory arena since the inception of FDA GLPs in 1978, including working as the Director of Quality Assurance within a large Contract Research Organisation (CRO).
Qualogy’s Contract Regulatory Archive facilities were established in 2000 under the management of a qualified regulatory Archivist. A fast growing secure archive, providing high quality archive services. The facilities are operated to the exacting standards required by the Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) Regulations.
Working with our clients, we offer a personal service with knowledge and expertise.
- Centralising your material with Qualogy could prove to be more cost effective, enabling your company to make significant savings. We can advise, liaise with clients and sites to assist in the logistics of moving material from across Europe.
We pride ourselves on having a high level of security and preventative measures in place including intruder and fire monitoring and alarms, fire suppression system, CCTV, temperature and humidity control and continuous monitoring.
With separate buildings on one site, we are able to archive Investigator Site Files (ISF’s) and Trail Master Files (TMF’s) independently.
Our systems have been inspected by the UK GLP Regularity Authority (MHRA).
In conjunction with the Scientific Archivist Group (SAG) we run bi-annual one day Archive training courses. Details and dates can be found on our website.
Tim Stiles is the co author of the Good Clinical Laboratory Practice (GCLP) Guidance document (ISBN 978-1-904610-00-7) and also operates a GCLP accreditation scheme. The scheme is aimed at laboratories who wish to demonstrate to sponsors of clinical trials and government agencies worldwide that their clinical laboratory operates to a standard that assures subjects rights and confidentiality as well as the reliability, quality and integrity of the work and results generated.
Qualogy runs an extensive number of Training courses for Good Clinical Laboratory Practice (GCLP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP). We can offer guidance and expertise in the implementation and operation with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) ensuring compliance with the regulations.
Tel: +44(0)1933 357953