Simon Brooks, Senior Director Product Strategy, Oracle Health Sciences
Drug Discovery & Development - March 31, 2011
The clinical trial process has reached new levels of complexity. Trials are longer, more expansive, more complex in design, increasingly global, and require new types of data. These changes mean that investigative sites must grapple with more subjects, visits, forms, and data validation, as well as multiple applications. Trials are also more costly, driving the need for faster insight into trial and site progress so that sponsors can make more informed decisions about the path forward.
Electronic data capture (EDC) technology has become the de facto standard for gathering and recording clinical trial data. The technology has matured over the years to keep pace with these rapidly changing clinical trial requirements, but it is also important to keep pace with the increasing proficiency and expectations of EDC end users.
EDC solution providers are redoubling efforts to develop solutions that are more efficient for this new generation of front-line users and also expand data visibility to cover all areas of study progress. Helping trial managers and sponsors expedite collection analysis of all their clinical data allows deeper insights and more timely decisions, speeding the all-important time to market.
Helping the front-line
Improved efficiency and usability are key concerns for EDC users on the front lines of data collection and management. Clinical research professionals are looking for systems that do more than simply present data; they need solutions that quickly and easily direct them to key tasks and help complete them successfully—whether registering patients, managing and cleaning data, or monitoring.
EDC solution providers are working to answer this call. For example, Oracle Health Sciences’ InForm GTM EDC solution has a redesigned user interface that helps users make quicker decisions, reduce errors and simplify navigation.
In creating the new InForm GTM interface, three usability design principles were applied:
• Signal-to-noise ratio, ensuring that important information stands out from peripheral information on a screen
• Information proximity, making certain that information needed to complete a task is grouped together on a screen for greater efficiency
• Streamlined workflow, simplifying the progression of documents and forms, as well as task delegation, from employee to employee or from sponsor to site
Leveraging these principles, InForm GTM’s interface features updated icons that make follow-up actions quicker to recognize and new controls that make it easier to navigate and filter. It also features improved query workflow that simplifies response exchange to speed query resolution; the user-friendly page layout also allows for more information to be viewed per page without scrolling.
Improving insight for managers and sponsors
With the cost of clinical trials continuing to escalate, study managers and sponsors need timely data on study progress to enable informed decisions about potential mid-study changes. Real-time reliable data and analytics are essential; InForm GTM provides on-demand and scheduled data extracts, as well as integrated advanced reporting that uses real-time data. These capabilities enable sponsors and managers to perform both ad hoc review and structured analysis earlier, and to more accurately spot trends and/or identify anomalies and move quickly to address them.
Electronic data capture solutions have hit their stride and are an indispensible clinical trial data management tool. A concerted focus to deliver expanded efficiency for front-line users—and real-time insight for trial managers and sponsors—will continue to fuel adoption and success.
Electronic data capture (EDC) technology has become the de facto standard for gathering and recording clinical trial data. The technology has matured over the years to keep pace with these rapidly changing clinical trial requirements, but it is also important to keep pace with the increasing proficiency and expectations of EDC end users.
EDC solution providers are redoubling efforts to develop solutions that are more efficient for this new generation of front-line users and also expand data visibility to cover all areas of study progress. Helping trial managers and sponsors expedite collection analysis of all their clinical data allows deeper insights and more timely decisions, speeding the all-important time to market.
Helping the front-line
Improved efficiency and usability are key concerns for EDC users on the front lines of data collection and management. Clinical research professionals are looking for systems that do more than simply present data; they need solutions that quickly and easily direct them to key tasks and help complete them successfully—whether registering patients, managing and cleaning data, or monitoring.
EDC solution providers are working to answer this call. For example, Oracle Health Sciences’ InForm GTM EDC solution has a redesigned user interface that helps users make quicker decisions, reduce errors and simplify navigation.
In creating the new InForm GTM interface, three usability design principles were applied:
• Signal-to-noise ratio, ensuring that important information stands out from peripheral information on a screen
• Information proximity, making certain that information needed to complete a task is grouped together on a screen for greater efficiency
• Streamlined workflow, simplifying the progression of documents and forms, as well as task delegation, from employee to employee or from sponsor to site
Leveraging these principles, InForm GTM’s interface features updated icons that make follow-up actions quicker to recognize and new controls that make it easier to navigate and filter. It also features improved query workflow that simplifies response exchange to speed query resolution; the user-friendly page layout also allows for more information to be viewed per page without scrolling.
Improving insight for managers and sponsors
With the cost of clinical trials continuing to escalate, study managers and sponsors need timely data on study progress to enable informed decisions about potential mid-study changes. Real-time reliable data and analytics are essential; InForm GTM provides on-demand and scheduled data extracts, as well as integrated advanced reporting that uses real-time data. These capabilities enable sponsors and managers to perform both ad hoc review and structured analysis earlier, and to more accurately spot trends and/or identify anomalies and move quickly to address them.
Electronic data capture solutions have hit their stride and are an indispensible clinical trial data management tool. A concerted focus to deliver expanded efficiency for front-line users—and real-time insight for trial managers and sponsors—will continue to fuel adoption and success.
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