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approximately $6.07 billion in 2011, with an estimated $11.54 billion in 2018. According to the report, phase III clinical trials account for the largest share of the total contract research organisations (CROs) market in Europe and CROs currently account for nearly two thirds of the Phase I to Phase III trials conducted globally. ‘Te availability of specialised research


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neutraceutical and food industries, Nova Biologicals must comply with the regulations of the National Environmental Laboratory Accreditation Program (NELAP), the EPA and the FDA’s GLP and GMP requirements. Standards – especially for environmental


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testing laboratories – have become far more rigorous as new regulations have been introduced. Tis means we and our clients must perform labour-intensive procedures to ensure compliance, such as sample tracking, chain of custody (COC), record keeping, demonstration of capability (DOC), document control, reagent and standard traceability, proof of training and reporting. Regulatory audits are unpredictable and


sporadic, so Nova’s labs must be constantly prepared to comply with an audit without creating debilitating delays. Our previous paper- based system made audits time-consuming and onerous. Now, because everything is stored in


6 SCIENTIFIC COMPUTING WORLD


technologies, coupled with an exclusive focus on drug development and testing, will boost the chances of success for CROs and


recent analysis of the European contract research outsourcing market by Frost & Sullivan has found that the markets earned revenues of


service


The unique requirements of contract research organisations (CROs) demand the deployment of sophisticated informatics systems, as Beth Harlen discovers


offset the benefits of in-house R&D services,’ commented Frost & Sullivan research analyst, Deepika Pramod Chopda. ‘Strengthening outsourcing partnerships and alliances with leading pharmaceutical and biotech companies through strategic long-term contracts will also support the uptake of CRO services.’ In order to maintain a high level of service


in what is an increasingly competitive market, CROs need to give careful consideration to their informatics needs. From vendors to contract research organisations, industry experts share the unique challenges of this market and the role that informatics solutions play in meeting them.


Dr Paul Pearce, CEO and founder of Nova Biologicals


s a full-service laboratory that provides testing and consulting services to the water, medical device, pharmaceutical,


chronological order with dedicated authorised folders sorted into months and years, the whole process of auditing is much easier and records are automatically updated. Managers can also now review records weekly instead of monthly making internal auditing more efficient. Auditing of training documentation is particularly key and this is where the LIMS


ALL STANDARD


OPERATING PROCEDURES (SOPS) ARE LOADED AND STAFF MEMBER TRAINING IS ALSO RECORDED


(laboratory information management system) is invaluable, allowing automatic updating of customer training records. All standard operating procedures (SOPs) are loaded and staff member training is also recorded. Our biggest challenges are to automate manual and paper processes, increase sample


throughput and improve efficiencies, all while enhancing customer satisfaction and ensuring compliance with the ever-growing demands of industry regulations. Meeting these needs can be hugely time consuming and expensive, especially when we also need to package and report quality control information, which is vital for sending to clients. Prior to implementing the Termo Scientific


SampleManager, we managed our work using paper that was supported by an outdated laboratory information system. Te lab system had data limitations and deficient reporting capabilities and continued use would not sustain the growing business in microbiology, medical device and pharmaceutical testing. In addition, since the old system was located on one computer, only one employee could use the system at a time, which created bottlenecks in the lab and significantly limited the volume of samples that could be processed.


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