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laboratory informatics

he adds. ‘However, conventional off-the-shelf laboratory information management systems (LIMS) aren’t necessarily customisable, whereas custom systems are time-consuming to build and reconfigure when requirements change. In contrast, UNIFlow has been designed to be ultimately configurable, based on the changing requirements of laboratories. Te platform puts the control firmly back in the hands of the lab, rather than the lab being at the mercy of the configurability and complexity of the LIMS.’ UNIFlow is based around the concept of

content flow, explains Bill Harten, UNIConnect’s founder and CEO, who specialises in the application of genealogical principles to laboratory problems. ‘At its most basic level we model, in the database, the contents of what goes into, say, a tube, and then when we aliquot something from one tube into another, we copy the record representing those contents from the source container into the destination container.’

Information flow With each portion of the overall workflow being thought of as a container through which information flows, this concept can be used to model and track all kinds of associations, and any object, process, activity or relationship from the assay steps and the ordering, acquisition and usage of individual reagents, instrumentation and samples, to results input, analysis, reporting and document management, and the whole relationship between CRO and pharma. Implementing an informatics platform based

on this concept enables the notion of flow to be expanded to include authority flow, accountability flow, and even monetary flow, such that the UNIFlow platform can act as a complete process management system, Harten continues. ‘What’s key here is that it becomes very easy and fast to implement and modify specifications. Qualified individuals simply need to define the process at the level of the new information that is being input or changed, and the system captures that data in terms of its flow through whichever containers it’s relevant to. It’s like building with bricks, rather than with grains of sand.’ For the scientists at the front end of the CRO operation, new assays requested by clients can be added into the UNIFlow system by staff in hours or a few days rather than months, the firm claims.

A hundred assays UNIConnect’s director of implementation, Clinton Maddox, was previously a biochemist at Southern Research Institute, and says the latter’s HTS centre has added over 100 assays to its UNIFlow LIMS in just two years. ‘Largely contracted by the US government, the HTS centre would get new assays assigned every month or so, and we had to have a system that was flexible

6 SCIENTIFIC COMPUTING WORLD ACD/Labs’ software can sit between a CRO and its clients and existing informatics platforms

enough to enable the scientists to easily create the specifications for every step and reagent of the assay, run the experiment, and then collate, analyse, and report the data. Prior to installing UNIFlow that was about a three-month process. Using UNIFlow, this task becomes much simpler. ‘Doing it this way we could input tens of assays

within a few months, and by the end of our second year we had done over a hundred assays. In fact, by six months we had undertaken the new assay procedure enough times that we had enough steps to match just about any assay that might come in to the HTS unit.’ UNIFlow negates the requirement for

multiple supporting systems that all have to be customised to interface, and upgraded when situations change, Mandahl stresses: ‘When you



factor everything into one system there are not only tremendous cost- and time-savings, but auditing becomes simpler, your processes are more transparent, compliance can be achieved and maintained more easily, and every other logistic and data transfer aspect of the CRO-client relationship can be managed seamlessly.’

Data format and downstream use Te delivery of data from CRO to client, in the format requested, and without loss of content or its usability downstream, can be a major headache for CROs. Germany-based BSSN Soſtware has developed its Contract Research Manager (CRM) process management system specifically with the CRO in mind, to manage workflows, capture all workflow, process and analytical data using the AnIML data standard, and automatically generate the requested deliverable for each client.

BSSN has pioneered the establishment of

AnIML, explains Burkhard Schaefer, BSSN’s president and the lead architect of the data standard, which is based on an open XML format that is human-friendly. ‘CRM and AnIML in effect allow the CRO and client to maximise the full richness of their data. It enables the storage and sharing, in a single space, of all experimental data – such as screening, spectroscopy, chromatography, biological and medical imaging – including sample and method information, along with analytical results, instrumentation details/logs and soſtware, and the workflow itself.’

A switchboard between CRO and client Featuring user-configurable dashboards, CRM sits between the CRO and the pharma client, acting as a kind of switchboard that patches disparate data through to each client as part of the workflow, Schaefer claims. ‘CRM effectively captures all the workflow data, and following review and approval of the data by the CRO, automatically generates the required deliverable according to the terms of the contract, providing the client with the same quality of data that would be generated by them in house.’ Te platform also manages work orders, requests and supplementary information sent to the CRO by the customer, allows clients to keep track of costs and monitor the progress of their projects, and provides access to the raw data as well as the specified electronic data deliverables (EDDs). Importantly, the CRM platform strictly controls the visibility of data, such that native data systems on either side are never exposed to the outside. ‘CRM doesn’t supplant any LIMS, ELN or

instrument management system that the CRO already has installed,’ he adds. ‘Instead, the platform establishes a bridge between the CRO’s and client’s systems, integrating with them and enforcing a well-defined, secure data flow pattern and maintaining all data originating from these different sources in a standard format and with no loss of content. What’s particularly exciting for

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