Brief Synopsis:

Clinical trials are becoming increasingly complex, and so have the challenges surrounding the management of clinical trials. Careful consideration of these challenges leads to a solitary conclusion: the technologies that acquire clinical data are not the problem, instead, it's the lack of insight into clinical data to identify study problems early is today's central management issue.

Generally, today's eClinical technologies are doing exactly what they were intended to accomplish. Technology advancements that enabled the transition from paper to electronic records have proven that clinical data can be captured more directly and quickly; access to these data can occur more rapidly; processing of these data is easier; and as a result, analysis and electronic submission of these data for faster approval are realized. Nevertheless, as this process has evolved, so have new challenges. There is a lack of data harmonization across different technologies. There is a need for increased vendor management and a need for better technical support. There is a decrease in staff required to support a study, and, at the same time, a seeming lack of control due to the inability to identify study progress and data readiness for analysis.

This white paper will discuss the need for a new type of eClinical technology that leverages these same eClinical sources in innovative ways to simplify and establish the data relationship back to the study protocol for management of the global study workflow. Through tracking source study data according to the study plan and data expectation, greater intelligence about the study progress can be realized; opening communications and defining clear actions to be performed to accomplish study goals.

Key Topics include:

• Leveraging the inherent data intelligence within acquired clinical data
• Rapid, single source decision-making
• Identifying in-stream protocol and source system changes
• Relating the study protocol to it's clinical data
• The Global Workflow Promise

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