LCG Bioscience located at Bourn Hall, claimed to be the worlds first IVF clinic, has implemented a new labelling system from global information technology solutions and services company, Episys, to ensure its compliance with MHRA (Medicines and Healthcare products Regulatory Agency) and FDA (Food and Drug Administration) validation requirements.
Challenge
Bourn Hall Clinic was founded in 1980 as the worlds first IVF clinic. Building on the pioneering work of Patrick Steptoe and Bob Edwards and the strong clinical research ethos they created, LCG Bioscience was founded in 1993. This new force in contract clinical research was quickly recognised for its innovative approach and delivery of high quality data. Attracting considerable inward investment from the biotech/pharma industry the facilities and services continued to grow rapidly.
Bourn Hall Limited runs two businesses, one of which is Bourn Hall Clinic, the IVF treatment centre, and the other is LCG Bioscience, conducting early phase clinical trials.
The changing regulatory environment and requirements relating to the labelling of investigational medicinal products to comply with the requirements of GMP, led LCG Bioscience to review its previous labelling system
After researching the labelling software and printers that were available they decided to upgrade to a new system.
Solution
LCG Bioscience selected Ultimate from Episys as they saw the benefits of the Episys one stop solution of software, printers and support, and opted for the Ultimate Platinum solution, which offers a higher security setting, a vital requirement for companies working in the NHS and Pharmaceutical industries.
Simon Barton, Finance Director of Bourn Hall Limited, said, Our initial research indicated that Episys provided a system that would tick all of our boxes in terms of functionality and requirements. This view was supported from receiving positive feedback regarding the system from another Episys customer.
Clare Lyon, Clinical Trial Co-ordinator at LCG Bioscience, who is responsible for producing the labels when they are running clinical trials, said, We are regulated by the MHRA and they come and inspect us on a regular basis and we need to comply with all their requirements, including labelling, for example blood samples from volunteers on trials and also the labelling of the drugs that we test in the trials. The main advantages that we saw with the Episys system was the validation package and the audit trail facilities, along with the design of the programmes that fitted in with other programmes weve used in the past.
The validation of Ultimate from Episys is vital to comply with all the regulatory requirements, and LCG Bioscience have taken the validation package that came from Episys. Security is also of great importance, and the Ultimate solution gives LGC Bioscience the functionality to ensure that users can only perform certain criteria, with the ability to allow somebody to manage the system overall, ensuring that only certain people can perform certain tasks.
Benefits
LCG Bioscience has found the system very user friendly. Clare Lyon, Clinical Trial Co-ordinator at LCG Bioscience, said, The design part of the package is based on other similar design programmes which means it has been easy for our users to adapt to. The training that we received at Episys ensured that we are able to use the system well. LCG Bioscience has also found the audit trail a useful functionality. The audit trail allows us to protect templates and control the integrity and security of the system. Weve made the right decision going with the Episys Ultimate system. It meets all of the regulatory requirements and is proving to be a system which our staff are able to use easily. commented Clare.
Episys clients include GlaxoSmithKline, GE Healthcare, Mundipharma Research, Reckitt Benckiser Healthcare, Roche, Smith & Nephew, Bio Products Laboratory, Boehringer Ingelheim, Cardinal Health, and many NHS Hospitals including Bristol Royal Infirmary, Cardiff & Vale NHS Trust, Guys & St Thomas Hospital NHS Trust, Portsmouth Hospitals, Royal Free Hospital, St George's Healthcare NHS Trust, Southend Hospital and Worthing & Southlands Hospitals NHS Trust.
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