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| home > epc > summer 2002 > application service providers - making the best in clinical research technology available and affordable |
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European Pharmaceutical Contractor
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The bar for implementing and operating many of the leading clinical research technologies continues to rise. In the past, the key decision companies faced was whether to build or buy. Today companies are increasingly moving away from building their own customised systems. The cost of developing and maintaining systems that can be flexibly adapted to changing business needs and regulatory requirements has become too expensive and risky. Industry leading commercial software minimises this risk but still requires a substantial investment in information technology (IT) infrastructure, including hardware/software, skilled technical resources, processes and procedures for maintaining a validated, regulatory compliant environment. I suggest the key decision that companies face in considering investment in clinical research technology or in planning a significant upgrade or retooling of their systems is whether to manage these systems in-house or to outsource their management.
Implementing and operating clinical research technology are not trivial tasks. The systems are complex and require continual support from staff who are trained and experienced in the software. For most companies this requires the minimum of an application specialist, a database administrator and a systems administrator. In addition, to meet the regulatory requirements for operating the system, a company must develop and operate within a comprehensive set of standard operating procedures (SOPs) that cover systems development, systems validation, change control or configuration management, security, back-up and recovery, and disaster recovery. All of the system components, as well as the applications, must be validated to prove that the systems have been installed correctly, are fully operational and meet all of the functional requirements for which the application was designed. Typically, the cost of the software is only a small part of the total cost of ownership, with most companies taking between six and 12 months to install and validate a clinical data management or safety system. Current estimates are that pharmaceutical companies spend about 22 per cent of their research and development budgets on computers, hardware, software, data centres, networks and staff (1). Given the cost, effort and risks associated with managing clinical research systems in-house, are there viable outsourcing alternatives?
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