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informatics for CROs LIMS have become much more prevalent


and necessary in our testing facilities as demand and regulations have grown and paper-based systems are no longer effective. A LIMS works by scheduling and holding sampling plans, which are then used to generate a collection run for each sampler. Te collection run defines where samples must be taken from, what sample bottles must be collected and what onsite tests have to be performed. Samples are then analysed in the laboratory and data, as well as details of what has been carried out in the field, is entered into LIMS. Tis is important as water companies must collect and analyse their water samples in a closely regulated environment, maintaining complete quality control records in case of inspection or audits. Te nature of sample testing means that there


are peaks and valleys – and some months, such as quarterly state reporting deadlines, are much busier than others. We may have as many as 1,500 Coliform samples to process in one day, and in the past it was a struggle to manage these


volumes because of the limited accessibility to the legacy system. With SampleManager, as many as five people can process samples at any one time – which means that we can now process very high sample volumes in a short period of time when necessary and gives us the ability to manage sample fluctuation. We’ve also seen improved efficiencies, better


quality and personnel cost savings. With five members of the staff being able to log samples at the same time, staff bottlenecks have been eliminated, saving many man-hours across the company. In addition, significant improvements in efficiencies and data quality have been achieved with the systems automation, built-in document management capabilities and report generation and distribution functionality. We’ve also seen improved customer service


and our responsiveness time has improved. SampleManager enables us to provide our clients with more meaningful information and data. For example, reporting on sample trends, patterns and volumes is something


Dominic Farmer, CEO of Cisiv C


ontract research organisations


(CROs) have to be at the forefront of


the pharmaceutical market when it comes to technology. Tey have to meet the needs of their customers when it comes to providing research services, but they also have to think about the impact on the investigators that are actually running their studies for them. At the same time, the need for clinical


research is changing as the wider pharmaceutical market evolves. While the number of drugs going through clinical trials may be falling, the number of treatments that are being reclassified or used in different markets is going up. Tis means that CROs are increasingly being called on to run non-interventional studies rather than clinical trials. Non-interventional studies are different beasts


to clinical trials. Rather than the strict rules of the clinical trial, non-interventional studies track real-world interactions between doctors and patients around treatments. Tese studies can be used to support drug re-classification, for example when a cancer treatment can be used to meet a new oncology requirement, or for pharmacovigilance purposes. From a technology perspective, CROs have to


date been using standard clinical trials electronic data capture (EDC) for their non-interventional studies. Tis approach has been driven by client


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requests, i.e. we want you to use a specific clinical trial solution as that is what we are familiar with, or because they are not aware of more focused solutions for non-interventional EDC. Te problem is that these EDC technologies


are oſten difficult for the investigators to use in a non-interventional study context. Tey are designed around a different class of data collection rules than those that apply to non- interventional work, for example. Clinical trial solutions also concentrate on a less dispersed model: a higher concentration of patients per centre and, overall, a lower number of patients. Lastly, clinical trial soſtware has not been


NON-INTERVENTIONAL STUDIES NEED A


DIFFERENT APPROACH TO DATA MANAGEMENT


developed to meet a need for localisation into multiple languages and for different healthcare compliance rule-sets. While it is possible to re-use clinical trial


soſtware for non-interventional studies, this may lead to problems for the CRO in the longer term. A key consideration will be around investigator retention, as a technology designed for one purpose is being used for a different application. As it is more difficult to enter data, the churn rate for investigators increases as frustration


mounts up. In turn, this increases the cost to run and manage the study and potentially lowers data quality. For the pharmaceutical company sponsoring a study, this becomes an issue if the data quality is not high enough to be relevant, or studies don’t produce the required set of results for analysis. It’s also an issue for the CRO as their business depends on supplying the research information that will meet the pharma company’s requirements. From being a technology pain point, it becomes a business issue as well. Non-interventional studies need a different


approach to data management that is less focused on data items and uses different methods to measure and manage overall data quality. New methodologies are needed to manage data as it is collected in very different ways. In essence, these methodologies are embedded in new technologies built specifically to focus on the problems that exist around real- world EDC and study management. As the need for this real-world data increases


and more studies are undertaken, CROs will have to expand their awareness of what these studies are designed to achieve and how their informatics solutions can help deliver this. CROs will take the lead in expanding how these valuable sources of data are compiled and delivered to their customers, but they also need to embrace what makes the non-interventional study different: the emphasis on the real world, rather than the clinical.


FEBRUARY/MARCH 2013 7


we have always been keen to do, but is now greatly facilitated by SampleManager’s ease of access to information. Tis adds commercial opportunities to our portfolio as we can tailor reports to individual customer requirements, offering a bespoke reporting format to a wider customer base. Finally, we’ve been able to reduce our reliance


on manual and paper-based processes. Te LIMS has helped us to significantly reduce the amount of paperwork used in its processes and methodologies. It has automated and accelerated processes within the company from sample collection to results and report generation, saving time and reducing costs through improved production efficiencies. Te solution has helped to eliminate manual error-prone processes, improve data quality and save substantial amounts of time. Furthermore, secure access to sample data is available for laboratory staff, remote users and external customers, enabling all system users to view the same information and ensuring consistency and clarity.


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