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informatics for CROs A main requirement of


contract organisations can often be the automation and integration of systems and instrumentation. Tom Curtis, VP of product innovation at Labtronics, points out that the review of data would often take a significant amount of time as everything would be sitting in separate silos, and that even if a lab did switch to an electronic system, it often remained isolated. ‘Now, advanced integration between informatics systems significantly decreases the amount of time and resources required to manage laboratory data throughout its entire life cycle,’ he says. LimsLink, a component within Labtronics’ iLAB, is an integration solution that connects instruments and informatics systems together. It automates the transfer of data between systems, which not only provides speed in transmission, but also assures accuracy. Commenting that some of the main business challenges for a CRO are integrating data acquisition, collection and reporting for improved efficiency, Marko Miladinov, senior IT specialist at XenoBiotic Laboratories, adds: ‘An ideal environment is to have a centrally-located and readily- available system that greatly contributes to data optimisation, data storage and security. Another main challenge is to eliminate manual recording to the extent possible by migrating to a potentially paperless and effective system that meets regulatory requirements.’ The system chosen to address


all these issues was an off-the-shelf LIMS named Debra. Developed by LabLogic specifically for drug metabolism and ADME (absorption, distribution, metabolism, and excretion) labs, Debra captures data directly in a GLP environment ensuring the traceability of knowing who captured what, on which instrument and when. According to Huw Loaring, systems director at LabLogic: ‘To have those GLP aspects and traceability within the data system also enables users


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to check if there have been any manual entries or changes to that information – it is easily tracked by an audit trail, which can then be filtered down by user or by a particular type of change, such as a manual weight entry.’ The LIMS covers the complete


life cycle from protocol definition through to the final report; helping users to prepare their formulations and treatments by calculating how much of the drug needs to be administered. It also covers dosing and the day-to-day sample capture, leading to the calculation of percentage recovery of dose and concentration data and the production of all reports, tables and graphs.


Accessing the data Research-intensive organisations face the issue of an inability to integrate data across multiple domains and, ultimately, a failure to get the most value out of the large and increasing amount of data that they are generating. Chris Molloy, VP for corporate development at IDBS, says that this problem is exacerbated as pharmaceutical and other companies increasingly outsource and distribute their R&D. Solutions such as IDBS’ E-WorkBook are therefore being used as data collaboration centres. ‘One of its main attributes is


that it’s capable of being a scalable data hub that reaches out into multiple collaborators and allows the central point, i.e. the pharma company, to have instant, full and secure access to the data wherever it’s produced.’ Around six years ago the company recognised that the emerging ELNs had become, in essence, fast-to-PDF solutions for data archiving, says Molloy. ‘We believed that they represented only one portion of what a scientist needed to do with the data and that the ‘end game’ for ELNs was as a true data management platform,’ he says. Thomas Schmidt, senior


product manager informatics at Waters, agrees that the platform approach is attracting interest. ‘When you look at the plethora of software systems that a typical lab


has to deal with, such as the LIMS and the electronic management system, you see that it can be very difficult for an analyst to work and exchange information. In the future, an entire lab platform will exist that effectively integrates everything within the lab. Not only will this increase the efficiency of the CRO, therefore making it more attractive to sponsors, but it will also ease the pressure on the people working on the bench,’ he predicts. Molloy feels that what is


needed in today’s industrial, pharmaceutical and academic R&D organisations, and their partners, is a data environment that supports multiple domains, multiple disciplines and enables secure but verified access to research data. ‘Niche desktop programs simply will not work in that environment. The entire R&D market is moving towards a more externalised environment than ever before and a certain degree of that will be in open collaborations as well as in the perhaps more established closed ones,’ he says. He also believes that we will see a growing


trying to accomplish, so they are getting more intelligent work as the contract lab can make suggestions to facilitate those end goals. A strategic relationship also ensures the CRO receives guaranteed revenue.’


Laying the groundwork The full collaborative environment is flowering, suggests IDBS’ Molloy, and large pharmaceutical organisations are looking to their CROs to acquire and invest in strong data infrastructures. It is no longer sufficient for a CRO to simply do scientific work at a reasonable price and quality. He says: ‘Distributed research is in reality outsourced data manufacture and if you consider it by that definition then you’re looking for a means of transferring the product of that manufacture to its site of use, and you’ll want to do that in the most quick and effective way possible with the maximum amount of contextual detail and with seamless access to the originating raw data for IP purposes.’


WHAT IS NEEDED IS A DATA ENVIRONMENT


THAT SUPPORTS MULTIPLE DOMAINS, MULTIPLE DISCIPLINES AND ENABLES SECURE BUT VERIFIED ACCESS TO RESEARCH DATA


trend towards open innovation platforms that will require the same scalable and searchable IT infrastructure. Relationships are becoming


more collaborative, says Trish Meek, director of product strategy for life sciences and informatics at Thermo Fisher Scientific. ‘One of the things CROs are really working towards is forming strategic partnerships, so rather than turning to their clients and asking for all the jobs relating to bioanalytical work, they suggest working on a project together and taking a drug from start to realisation,’ she says. ‘The benefit of this approach to the pharmaceutical company is that they have effectively educated the CRO on what it is they are


One option for creating an


accessible infrastructure is the internet and Meek explains that an increasing number of contract labs are going down this route. ‘What we’re seeing in some contract labs is that they are actually using the internet as a backbone. One of our customers isn’t actually building a way in at all; rather they want to be able to securely transfer information not only to customers over the internet, but also internally in their infrastructure,’ she says. Meek points out that if you look at the storage of data over the past 30 years, it moves back and forth between data being localised on desktops and data being stored on servers: ‘There’s no reason why this can’t extend to the internet.’


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