LABORATORY INFORMATICS
Contractual obligations
SOPHIA KTORI EXPLORES THE USE OF INFORMATICS SOFTWARE BY CONTRACT RESEARCH ORGANISATIONS
functionality that makes the most of the most recent operating systems and browsers. ‘The latest user interface has been developed to take advantage of HTML5, and incorporates a spreadsheet- like results entry form, which is pretty much like Excel. This simplifies results entering, including the importation of data directly from instrumentation. HTML4 wouldn’t have supported that.’ Version 4 also offers a ‘what you see is
The benefits of building a good working relationship between a LIMS supplier and a contract
research organisation (CRO) can’t be underestimated, notes Richard Stember, founder and CEO of LABTrack, which has been working closely with CRO Nitto Avecia Pharma Services (Avecia Pharma) and its predecessor for the last 12 years. The regulatory compliant LABTrack LIMS was originally built as a customised system for Avecia Pharma, but was commercialised more widely in 2007. The LABTrack LIMS system needs
to stay relevant to Avecia’s expanding global business, which spans the complete range of contract development and manufacturing services for small molecule, oligonucleotide and biologic drugs. ‘Scalability and flexibility have been key to meeting Avecia’s growing and diversifying workload,’ Stember explains. ‘The company needs a highly configurable LIMS for working in a GLP environment reliably and defensibly. We developed the solution as a thin client application, so it runs inside a browser, which simplifies implementation.’
Evolution of LIMS technology The current, fourth release of LABTrack LIMS has been developed to provide
18 Scientific Computing World October/November 2017
what you get’ (WYSIWYG) environment for defining new entry forms and reports and queries, Stember points out. ‘This allows our new customers to evolve the LIMS to manage each new project as it comes in. With version 4 you don’t have to hard code new forms in. NET, you can drag and drop fields and lists and create queries to support those forms.’ The LABTrack LIMS is, in addition, highly project orientated. ‘It’s a key requirement for CROs.’ Stember stresses. ‘Our software can manage a client-CRO relationship from the point of proposal to the client, even before the purchase order is received. The software then manages and oversees each stage, including analytical testing, peer review, laboratory management review, QC review, and sample administration steps, all within a GLP environment.’ Avecia Pharma has separately installed
LABTrack’s Stability Study Management System (SSMS), and is in the process of deploying the latter’s project management dashboard (PMD), which interfaces directly with existing accounting, ERP, LIMS, CR and ELN systems. ‘This will allow the whole organisation to work under one umbrella,’ said Nahid Ameri, senior manager, corporate planning at Avecia Pharma. ‘Currently, each department has its own
system for keeping track of jobs. Having a PMD that interfaces with the LIMS will make every job visible to all authorised personnel. I have no doubt that it will add lots of efficiency to our organisation.’ The PMD is also project orientated,
Stember notes. ‘The PMD is an organisation-wide dashboard that intersects with the LIMS to provide management capabilities and visibility for every workflow. Users can immediately view the status of tasks for each of their projects – including any hold-ups or bottlenecks – so they can respond faster.’
Consolidating data Consolidation within the CRO space is increasing competition for major global players and for more specialist firms, and this pushes business development and marketing into the daily workflow, says Nancy Rourke, senior product manager, life sciences, at Abbott Informatics. ‘Whereas many organisations that we work with, including public health bodies and pharmaceutical companies, have separate marketing departments that function to build business and increase competitiveness, CROs expect to integrate an element of marketing oversight, management and intelligence into their everyday business, and that functionality will ideally be embedded in a LIMS.’
Individual firms therefore look for a LIMS that can offer more than just the testing and reports, Rourke suggests. ‘The platform has to stand out in both the pre-analytical and post-analytical functionality. It’s not uncommon for firms to build Frankenstein systems that require them to operate one software for accessioning and client requests, a
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