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Customers Integral to Oracle’s Reshaping of RDC 4.5.3

Author: Kathy Miedema, Oracle Applications User Experience
April 6, 2009




When key customers from the pharmaceutical world came to Oracle recently, asking for improvements on Oracle’s electronic data capture (EDC) software for clinical trials, Oracle decided to step back and start fresh.

“Previous versions of Remote Data Capture (RDC) were fine, but they definitely weren’t as finely tuned as they could be,” says Michele Becci, Senior Director of Global Strategic Accounts in Oracle’s Health Sciences Global Business Unit (HSGBU). Out of those initial meetings came RDC 4.5.3, Oracle’s completely redesigned application for physicians, also called investigators, who gather patient data in clinical trials for new drugs.

“It became a much more involved design process than we planned, and the result is, we really got it right.”
– Greg Jones, Vice President of Applications Development, Oracle’s Health Sciences Global Business Unit

“Customers loved the fact that we took a step back,” says Greg Jones, Vice President of Applications Development for Oracle’s HSGBU. “But in doing this, it turned out to be a lot more complicated. We had to evaluate key business process flows to really nail the design down properly. It became a much more involved design process than we planned, and the result is, we really got it right.” Oracle’s user experience (UX) team brought customers into the months-long design process from the very first step, as they tested and evaluated the evolving RDC 4.5.3 design to ensure that the application was exactly what clinical trial investigators wanted and needed.

“We decided to start from ground zero,” says Madhuri Kolhatkar, Director of Oracle’s Applications Unlimited User Experience team, about redeveloping the application. In 2007, when work began on redesigning RDC, “we took the opportunity to create a real customer focus. We really focused on customer user problems – and once we knew that, we focused on redesign. We totally turned customers around. When they saw the product evolve, and saw that they were able to contribute to its evolution, the perception and hope of how the design would be more geared toward an end user’s needs became apparent.”

The Problems

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Kailash Dattkaya – Oracle Applications Unlimited User Experience

A clean, easy-to-read grid view in the updated Remote Data Capture (RDC) 4.5.3 software application, used in clinical drug trials, enables investigators to call up several case report forms at once and easily manipulate the data.

When representatives from pharmaceutical companies first began identifying the problems with earlier versions of RDC, a few things stood out, says Erika Webb, a User Experience Manager who worked on RDC project. “Workflows were not streamlined. Patient information was available, but it was not easy to get to things and sometimes a user had to go through several screens to find what was needed or bounce back and forth between screens. We started by trying to understand the tasks – we got the development team’s perspective, we got the strategy team’s perspective.”

UX professionals also examined the information people might need to access, depending on their role in a clinical trial, Webb says. The software application needed to make patient data easy to get to regardless of whether the user was an investigator gathering data or an auditor checking the data for accuracy.

It became clear rather soon that RDC 4.5.3 needed to be quicker, more responsive to users, and that users needed to get to their information from any computer.

“What we were hearing is that it wasn’t doing what they needed it to do,” Webb says of the earlier versions of RDC. Oracle’s team took that information and tried to figure out why users couldn’t do what they wanted to do. “We tried to address the underlying difficulties that the customer was having. Is the screen designed correctly? Is information where the customer needs it to be? What are people trying to accomplish, and how can the design make things easier for them? How can we make the workflow more efficient and productive?”

Webb said nine investigators and eight auditors were involved in the usability testing of the redesign. “Making sure RDC 4.5.3 satisfied both types of users was a big challenge,” she said. After testing the RDC prototypes with these users, findings from the tests were incorporated into the new design.

The Solutions

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Kailash Dattkaya – Oracle Applications Unlimited User Experience

On RDC 4.5.3’s data entry screen, users no longer struggle with slow-moving PDFs. They can also right-click on items, bringing up menus (such as the one in the center of this graphic) that helps users to complete tasks more efficiently.

Designer Kailash Dattkaya spent two months in the United States creating a prototype while working with customers, and he spent several more months working on the redesign from India, where he lives. He says the new features for RDC became very focused on improving the workflow, providing multiple ways to complete a task, making it easier for all users to find tools, and resolving discrepancies.

“The basic requirement was to help users be more productive,” Dattkaya said. “When we started working on and looking for solutions, we realized we had to take the plug-in out.” Previous generations of RDC used a plug-in application for PDFs, where the patient data was collected and stored, and that slowed down users’ work and impeded their progress when they were traveling and didn’t have access to the same computer. Becoming a zero-footprint application, which erased the need for a plug-in, boosted the speed of RDC by about 70 percent, Dattkaya said. These changes also allowed users to interact more easily with the data entry program when inputting data or just checking it against another report.

In clarifying the design, Dattkaya said, RDC 4.5.3 became more user-friendly, which helps minimize the amount of training needed to learn how to use the application. Key actions were added to the tool bar, making certain tasks easier to reach, and the task flow was redesigned. Case Report Forms, or CRFs, were simplified so that users could see everything side-by-side instead of having to toggle back and forth between screens. Users could now collapse and expand certain columns of data, or define data by age group or other categories.

The Result

“This really hits the mark.”
– Jerry Whaley, Pfizer

“We went through a lot of redesign,” says Kolhatkar, of the Applications Unlimited User Experience team. “After multiple iterations of the design, it was clear that the customers were very happy with the solutions that we built. We got some great feedback from customers.”

Jim Streeter, Executive Director of EDC for Pharmaceutical Product Development, Inc. (PPD), a contract research organization (CRO) that runs clinical trials for pharmaceutical companies, told Oracle during the redesign: “I’ve been looking at your competitors the last three weeks, and the product you showed us today is extremely competitive with them, especially the data entry piece. In fact, the data entry piece is superior to the competition. This is really, really fantastic.”

Streeter later said in an Oracle news release: “The newest version of Oracle Remote Data Capture Onsite offers increased automation by providing edit cache and validation at several steps in the process. This unique functionality yields cleaner data, faster – enabling CROs, like PPD, to help our clients complete trials faster and accelerate time to market for new products.”

Other customers agree. “This really hits the mark,” said Jerry Whaley, a representative for pharmaceutical giant Pfizer who participated in the redesign of RDC 4.5.3.

“What that ultimately means is that more and better medicine gets to the market faster, which helps people get better faster.”
– Greg Jones, Vice President of Applications Development, Oracle’s Health Sciences Global Business Unit

Since the rollout and adoption of RDC 4.5.3 during 2008, PPD has begun using it in about 80 clinical trials in 40 different countries. “These are global studies,” Jones of Oracle’s HSGBU says.

“This is an example of how we showed the health sciences sector that UX can really make a difference to the product,” as more automation such as software applications are introduced, Kolhatkar says.

“Our guys who worked on this application area are user experience experts who understand the art and science behind human interaction,” Jones said. “In being able to work with top pharmaceutical companies in the world, we really came up with a big winner.”

“What that ultimately means is that more and better medicine gets to the market faster, which helps people get better faster,” Jones added.

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