With a solid Quality Assurance background in both pharmaceutical manufacturing and R&D, Karen Bateman is looking forward to bringing her impressive skillset to her new role as Head of Quality Assurance at LCG Bioscience, the specialist clinical research centre based in Bourn, Cambridgeshire.
“Working at LCG provides a fantastic opportunity for me to consolidate my experience and expand my skills, and provides a new challenge – the opportunity to manage and further develop the already excellent quality systems in place here,” she says.
Karen has joined LCG from Phytopharm plc, a pharmaceutical and functional food development company. “Phytopharm operates on a virtual business model so has no laboratory or manufacturing facilities of its own – everything is sub-contracted out,” she explains. “The staff are responsible for managing the work that sub-contractors undertake on behalf of the company. One aspect of my role was to audit the sub-contractors to make sure that they achieved the required regulatory and in-house standards in terms of their facilities, systems, procedures and documentation.”
LCG is very different, having a range of state-of-the-art laboratory, testing and patient facilities on site, but Karen believes that there are some similarities. “I’m still responsible for managing the audit programmes but there are now more internal audits than external ones!” she says.
“It’s a challenge for me, but I’m finding it fascinating. We have a huge range of staff here including medical doctors, nurses, laboratory staff and project managers. It is essential that our staff are appropriately trained to undertake their tasks to the high standards required, and that we keep accurate, detailed records of all our activities. Audits undertaken by the QA team and those conducted by study sponsors help provide the evidence that we meet, and even exceed, the standards.”
Karen started her career at Reckitt & Colman (now Reckitt Benckiser) as a junior lab technician, and worked her way up to laboratory manager before moving into the QA arena. “Working at Reckitts gave me an excellent grounding in Quality Assurance and Good Manufacturing Practice (GMP) requirements,” she says.
Karen enjoys working in Quality Assurance as the role is constantly evolving. She is aware of the changing regulatory environment and monitors amendments to the requirements closely. Her role helps ensure that LCG maintains its position as a highly-accredited CRO working to the highest standards.
“It’s vital to keep up to date with changes in the GCP and GMP requirements and to implement these quickly and accurately,” she says. ”LCG Bioscience has repeatedly demonstrated its commitment to the highest standards. It was awarded MHRA Supplementary Accreditation in June 2008 – one of the first centres to achieve this. The accreditation enables the facility to conduct First in Human trails involving drugs requiring Expert Advisory Group review.
“Working at LCG provides me with exciting opportunities that are hard to come by elsewhere.”
LCG Bioscience has the expertise and facilities to conduct complex studies incorporating hybrid protocols that use healthy volunteers, patients and biomarkers. Studies have included large biotech molecules and the development of novel biomarkers for safety and physiological evaluations.
Working within a highly regulated environment, Karen is determined that quality should be central to all activities carried out by LCG Bioscience.
“Everyone is responsible for the quality of their own work. The role of the quality assurance team is to ensure that the systems and procedures in place for all tasks undertaken at LCG are appropriate and adhered to,” she says. “These procedures should say what we do, we must do what we say and be able to prove it!”
Karen is a Qualified Person for the release of Investigational Medicinal Products and has a Diploma in Analytical Chemistry from the University of Hull. She is a Chartered Chemist, and is a Member of both the Royal Society of Chemistry and the British Association of Research Quality Assurance (BARQA).
About LCG Bioscience
LCG Bioscience is a fully MHRA accredited, purpose built clinical research organisation for exploratory and early phase clinical development. Established in 1993 it performs Phase I and Phase IIa clinical studies and laboratory analysis for all phases. It has particular expertise in studies that require biomarkers, complex clinical procedures, special populations, or surrogate pharmacodynamic endpoints. It has specialist facilities for respiratory and sleep trials.
LCG Bioscience is an operating division of Bourn Hall Ltd and is located at Bourn Hall, Bourn, Cambridge, CB23 2TN, UK Tel 01954 717202
