Pharmaceutical Executive Europe - March 2007 - (Page 6)

Linking People, Process and Technology John Aggerholm outlines why those responsible for clinical operations should be taking control of system integration — traditionally the role of the IT department — to optimize their R&D processes. raditionally, an organization’s system integration has been taken care of by the IT department, with any interface created typically being initiated by a single request from a system-owner. IT departments have maintained a common method of system integration, but this has been considered a technical process and has not been communicated to the line of business-responsible department or vice presidents VPs responsible for clinical operations. Those responsible for clinical operations have maintained a picture of the clinical work processes based on the necessary standard operating procedures SOPs created in the organization over time. These are usually coordinated in such a way that an abstract picture or theory can be traced all the way down to SOPs. But recently a new world has emerged — a world where the goals of clinical operations that is, more trials, faster, better and cheaper have become increasingly hard to achieve. In order to bring the traditional silos trial management, supply, data management, biostatistics closer together with the aim of optimizing an organization’s processes, the number of e-clinical projects being carried out by pharma companies has drastically increased. Each project, essentially a large change management project with an IT component as the T enabler, is expected to create benefits that impact all the silos. At the same time, any organization can, both financially and organizationally, only afford and handle a given amount of changes to optimize and plan for this, so it is essential to prioritize tasks and maximize the benefits of the resources available. Business architecture There remains, nevertheless, a missing link: the link between process work essentially impacting on the entire organization, SOPs and job roles and the IT systems and integration work. This missing link is becoming increasingly obvious to all those working in these projects, and it is also becoming apparent that, in order to optimize operations, it is now necessary to review the company’s symbiosis of its process, its organization people and its technology. A potential link, called a ‘business architecture,’ is a method connecting the disparate areas of process, organization and technology. Each of the three areas has its own subdivisions: processes divide, in ever greater detail, down to SOP and instruction level; organization has levels covering department, roles and job descriptions; technology covers systems, interfaces and data flow. The responsibility for creating this overview of the business, and to ensure that it is coordinated and MARCH 2007 CLINICAL TRIALS MANAGEMENT 6

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007

Linking People, Process and Technology
Building Alliances
Finding Success in Asia
Selecting South Africa
Advance from Europe
EDC: Are We Missing the Boat?
The Right Equipment
Next Stop: Vienna

Pharmaceutical Executive Europe - March 2007