laboratory informatics


externalising any research or workflow is how to align your normal working processes and protocols with those of your partner or service provider, comments Paul Denny-Gouldson, vice president for strategic solutions at IDBS: ‘It doesn’t matter whether you are big pharma wanting to outsource or collaborate using your own protocols, or if you are a CRO, CMO or platform company that needs to externalise a process. One of the major questions is, “how far can I allow my working processes to be changed to facilitate that externalised work, and what constraints do I need to put in place?”’ Ideally an organisation will have a centralised team that can deal with establishing the groundwork, legal framework, business rules and informatics infrastructure for all


www.scientific-computing.com l


SOME ORGANISATIONS


MAY SEND OR RECEIVE DATA IN A FORMAT THAT SUMMARISES INFORMATION TO ‘PLAY IT SAFE


externalised work, Denny-Gouldson states: ‘But in reality, most pharma companies haven’t yet set up a dedicated team to centrally manage all of those processes and policies.’ Te situation becomes even more


complicated when you are transferring physical samples or compounds as well as packets of data: ‘Once you get into the latter stages of


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development or into manufacturing, then the likelihood is that an organisation will have a laboratory information management system (LIMS) in place that can track and manage samples, both within the home organisation and once they are passed out to collaborators or service providers. However, at the research or early development stage there may not be an infrastructure in place for sample management.’ Another issue is how to incorporate data coming back into an organisation, into the overall scientific discovery and development workflow. ‘Data being returned will oſten be in a PDF, or Word document, and so someone will have to key that data back into the company’s internal systems to make it usable. Tis causes delays,


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