Clinical development costs are soaring, as Pharma grapples with the challenges of making increasingly complex new products. Several highly-publicized problems with products that have already reached the market have also put drug safety center stage once again. One of the most important technologies for addressing these problems is electronic data capture (EDC) – the capture and management of clinical trial data in an electronic format (see Figure 1). EDC is much more accurate than the traditional, paper-based processes for recording trial patient data. It also provides access to the data on a realtime or near realtime basis and offers considerable cost savings. However, making the switch to full-scale EDC is difficult – a fact which explains why many pharmaceutical companies are not yet using EDC on 100 percent of their trials. Experience at IBM Business Consulting Services shows that implementing EDC successfully requires a strategic approach that includes a new culture and corporate processes, as well as rapid scale-up to help realize the full commercial benefits and reduce the costs associated with running dual processes, training staff and so forth. It is also vital to implement any EDC initiative in tandem with other corporate objectives and integrate the technology with the rest of the corporate IT infrastructure. Once a company has formulated its strategy, it must address four key areas: - Process change. Major changes are often required to support the introduction of EDC. These include setting up processes for creating and maintaining electronic case report forms; procuring, configuring, testing and shipping laptops to investigators in different countries; defining the preferred way of entering data; controlling access to the data; and archiving the data in a legally compliant manner.
- Technology. It is equally important to create a robust, secure infrastructure. The first step is to choose the right software – and the reliability of the vendor should play a major part in this decision, since many EDC suppliers are not accustomed to working on the scale at which leading pharmaceutical companies operate. The second step involves the hardware on which the EDC system is to run. Pilot studies can often be performed on a company's existing infrastructure, but using EDC for hundreds of trials is likely to require additional hardware and network services. Two other related and vital steps related to technology are safeguarding data and integrating the technology with other clinical systems.
- Site assessment, enablement and support. Consistent global support is vital – and here, it is imperative to start by assessing each site to establish precisely what equipment each investigator will require. Maintenance is another key issue, as is the provision of training and ongoing support via a trial support center.
- Organizational change. Full-scale adoption of EDC requires major cultural and organizational changes. These must be clearly defined and communicated, so that the clinical development, clinical operations and IT functions can work toward a set of common goals. Visible commitment at board level or from the global head of development is also crucial to successful implementation.
Companies that switch from paper to electronic trials can reap substantial financial savings and reduce the risks to the patients on whom they are testing their products. They can also begin creating an eClinical environment. With an integrated information infrastructure, it is possible to consolidate clinical data from numerous different sources and see "the big picture." This is the real goal for an industry that must make more, and better, drugs to meet the needs of patients and shareholders alike. 
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