LABORATORY INFORMATICS g ‘Any software must be able to


personalise client workflows.’ The Edge offers its BioRails platform


as a hybrid system that combines LIMS functionality with elements of a logistics tracking system, so CROs can optimise all aspects of services provided to multiple clients, as well as manage sample handling and results reporting and analysis. BioRails combines a project tracking and optimisation (PTO) module, with a data management element that combines electronic laboratory notebook (ELN), and data analytics. A plate- and vial- based inventory module offers seamless management of small molecules, biologics, cell lines or tissue samples. ‘BioRails allows CROs to optimise


project planning and scheduling, down to the individual items of test equipment being used, and locating materials in store,’ Lemon said. ‘CROs can assay sets of samples from different clients in the same test run, even if all other aspects of that workflow are different for each client. ‘It saves on resource and reagent use, without compromising on data security or the specific reporting requirements for each client. We also provide functionality in our software that allows clients to carry out cocktail testing, where multiple samples are run together in the same well, in the same plate,’ Lemon added. BioRails provides the option to monitor


quality variation and efficiency over time, while metrics tally the number of compounds that have been run using each type of assays, over specified time periods, as well as assay/sample turnaround times. Larger CROs also have very different


software requirements from smaller organisations, notes Joe Rajarao, client engagement manager at IDBS. ‘The diverse and often disparate sub-groups that comprise larger CROs tend to operate as distinct cost centers, and are often isolated from each other due to workflow specialisation or geography. A common platform that facilitates the sharing of information becomes a paramount need.’ Informatics platforms should also ideally be domain agnostic to support the workflow diversity represented by multiple sites, Rajarao stresses. ‘For example, a CRO might have one site that provides environment monitoring, another that services the biopharmaceutical industry and yet another that conducts clinical trials. Any platform needs to provide continuity to ensure any clinical sample generated is traceable throughout its lifecycle. Lab management and QA must be able to follow the sample from the clinic through to the lab testing regimen


20 Scientific Computing World October/November 2017


and be visible to the project sponsor. Vendors have to be aware of this very important aspect in the architecture and implementation of software solutions.’ As more companies are looking to


CROs as external partners and not just as outsourced resource providers, their relationships with their clients have evolved from transactional exchanges to more long-term collaborations. Legacy options for the transfer of data, such as email, file-share, Dropbox or SharePoint, are not ideal with respect to giving study sponsors the option of reviewing data with more depth and context than a final result table stored in a slide presentation or document, he believes. ‘To address these needs, CROs have


deployed myriad purpose-built solutions that deliver specific capabilities,’ Rajarao notes. These ‘point solutions’ tend to be very effective in the tasks for which they were designed. However, the resulting data silos mean that study managers often have to spend significant time mining these systems and manually compiling data. ‘The ability to aggregate relevant data from disparate point solutions to compile the final study report will be a significant improvement to a CRO’s product capability, and profitability.’ Precision tumour diagnostics firm Helomics established a clinical CRO operation at the start of 2017, and now offers pharmaceutical, biotech and


“Any platform needs to provide continuity to ensure any clinical sample generated is traceable throughout its lifecycle”


diagnostic clients a range of ‘boutique’ services for clinical and translational research, spanning biochemical profiling, genomics, proteomics and cell biology. ‘It’s an extra revenue stream on top of our clinical diagnostics business and allows us to leverage our proprietary patient- derived tumour models to help develop new therapies,’ noted Mark Collins, vice president of innovation and strategy. Helomics is not alone in this shift, with


many diagnostic firms now providing specialised services beyond the scope of the traditional CRO’s remit, he points out. ‘Modern clinical trials are highly data- driven. You are selecting cancer patients based on biomarker profiles.’ These types of specialised biomarker panels, including the patient-derived tumour assays offered by Helomics, in turn require highly flexible


 Avecia Pharma has installed LABTrack’s SSMS


informatics systems that can manage process and analyse complex data. Helomics is leveraging its proprietary


regulatory-compliant D-CHIP (dynamic clinical health insight platform) bioinformatics platform, launched in April, which applies machine learning to data from multi-omic studies in the database for insight about how patients are likely respond to drugs. Helomics has also employed Abbott Informatics’ STARLIMS for the last six years as its clinical diagnostics LIMS, and is now deploying STARLIMS to drive its CRO business. While flexibility is key, you don’t want a LIMS so complicated it becomes impossible to maintain. ‘That sort of ‘lifeboat’ software – which has every kind of functionality for every kind of eventuality – becomes a beast to maintain,’ Collins said. ‘Sometimes a more focused solution can work better.’ Absolute security is also a key consideration for Helomics, adds Robert Montgomery, manager of IT and LIMS. ‘We want to be able to set up and


configure new projects within days, not weeks, and have role-based permissions that guarantee client data security and meet regulatory guidelines and rules we are subject to, such as CLIA. As a boutique CROs, we need software that is project centric to manage diverse and often complex workflows for individual clients, which is very different to the sample-centric structure of a traditional LIMS. You want to be able to keep all your project data together, and easily accessible, and available to the sponsor, in the correct format, in just about real time,’ Montgomery concludes.


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