LABORATORY INFORMATICS
separate LIMS that handles the analytical processes, and then a third system for their client management. But CROs need a platform that can manage an end-to-end workflow. Organisations are increasingly looking for a single vendor solution that can consolidate all their data systems.’ The CRO space is also becoming
increasingly multifunctional, Rourke adds. Many CROs carry out contract manufacturing, and offer sample biorepository services. ‘Even just a few years ago companies would have required three separate informatics systems to manage their contract research, manufacturing and biorepository operations. Today, Abbott Informatics’ STARLIMS
offers full clinical research and manufacturing capabilities that handle post-launch QA and stability studies, as well as biorepository functionality for true end-to-end traceability, and the flexibility to manage changing regulations that govern their operation.’ The flexibility built into STARLIMS means that CROs can easily set up projects with new clients. ‘Our customers can pretty much design their own workflows and data capture forms from start to finish, to match how they work with each individual client.’ This is configuration, not customisation, Rourke stresses. ‘Users
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”This allows our new customers to evolve the LIMS to manage each new project as it comes in”
can make the system look and behave as they need it to, without any loss of configuration or personalisation whenever there is a new upgrade.’ STARLIMS simplifies the creation of
personalised dashboards for each client or project, from client data and contract information, to the creation of multiple projects for each client and project- related protocols. Testing price lists, visit schedules, consent forms, visit dates, and even how the test results are reported and communicated can be personalised.’ Abbott Informatics is continuing
to evolve the STARLIMS software to accommodate new technologies and testing workflows. ‘The increase in molecular technologies such as next generation sequencing, involves complex methodologies and workflows, and we are developing uncomplicated user tools to accommodate these workflows and simplify data management and analysis, ‘The trend for CROs to act as secondary
biorepositories is also driving us to build our software with more seamless
transitioning from clinical testing to long-term sample storage, so that data is available in a single system for future regulatory review or testing,’ Rourke said.
Overcoming inefficiency There is a real need for software that can link business development and customer demand with sample- and test-oriented functionality, said Andrew Lemon, CEO at The Edge Software, concurring with Nancy Rourke. ‘In the preclinical, as well as clinical arena, the CRO works on the ground with customers, negotiating on SOPs, costs and timelines for studies. They must then transition all that data back into the business management infrastructure to set up workflows and protocols, carry out the studies and deliver validated results back to the client. Ideally that happens within the same infrastructure that manages and oversees the experimental, analytical and reporting side.’ There is a huge amount of inefficiency
that can creep into that process, however, Lemon believes. ‘The key is to automate as much of the process as possible. CROs need to ensure that every stage is transparent, and there is a seamless chain of custody. This is easier said than done, as workflows for each client will involve individualised approaches to how the data is managed and the results are delivered …
October/November 2017 Scientific Computing World 19
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