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International Clinical Trials

Data on Trial

In the traditional pattern of infrastructure provision, especially in the non-commercial sector, IT hardware and software were managed directly by the data management organisation (DMO) itself – for example, a university trial’s unit would have its own servers on its own premises (see Figure 1A). Much more commonly these days, the IT infrastructure is provided as a set of database and web servers by the parent organisation’s central IT department, and the DMO maintains its clinical database management system (CDMS) software on top of that platform (see Figure 1B).

Central IT departments are, unfortunately, not always responsive to the particular needs of DMOs and their regulatory compliance requirements and may not be as flexible or cost-effective as a cloud-based Platform as a Service (PaaS) supplier. Increasingly, DMOs – whether university trials’ units or CROs – are examining outsourcing IT infrastructures by seeking an external PaaS service, looking to retain control while avoiding the headache of direct infrastructure management.

Alternatively, some DMOs are looking at outsourcing their entire CDMS and subscribe to a Software as a Service (SaaS) service, which is often hosted by the system vendor. In the latter case, the CDMS host themselves typically use an external PaaS service for their infrastructure (see Figure 2).

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Steve Canham is a freelance IT consultant specialising in clinical trial IT systems within the non-commercial sector. He is an IT and Data Management Auditor for the European Clinical Research Infrastructure Network (ECRIN) and a member of the ECRIN Data Centre Standards review group, a well as being involved in various Horizon 2020 projects and in system and study development in the UK and Europe.

Will Crocombe is Director of RISG Consulting, providing independent information systems (IS) and governance advice to CROs. Will was IS Director at the University of Leeds Clinical Trials Unit for over a decade, chaired the UK Clinical Research Collaboration IS Working Group, has worked on a national and international level with the National Institute for Health Research, Cancer Research UK and was a reviewer of the ECRIN Data Centre Standards.

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Steve Canham
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Will Crocombe
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