DataTrial Ltd Finds Ideal Solution to Improve Clinical Trials Process and Comply with EU and FDA Regulations with Logi Ad Hoc Reporting

About DataTrial, Ltd

Datatrial, Ltd is a UK-based company that provides customized electronic data capture solutions (EDC) to the pharmaceutical industry. EDC solutions capture clinical trials data in an easy to use Web interface that allows clinicians on both sides of the trials (study site and sponsor office) to gather, analyze and communicate about data in an efficient manner.

Datatrial customizes its solution to meet individual client's requirements and business processes. Using a core platform of technology, Datatrial integrates data from a variety of sources into a Web-based EDC system that matches a client's requirements exactly. Datatrial is leading the way in the race to develop user-friendly, scalable EDC products and is poised for impressive growth.

DataTrial's Challenge

Most EDC solution vendors provide tools that capture data but do not provide the reporting functionality needed to make that data accessible and actionable. As a result, companies entrenched in clinical trials research must choose an additional vendor, often at
significant costs, to interact with their data.

Challenging the status quo, Datatrial set out to develop a single EDC solution through which clients could gather, access and analyze data throughout the entire clinical trials process. Creating this complete solution meant that Datatrial needed to add ad hoc report building and querying functionality to its existing EDC solution.

The challenges of the project were defined, primarily, by the needs of Datatrials' end-users and internal technological specifications as well as required adherence to industry regulations.

"We wanted a complete solution that was transparent to our end-users," said Jonathan Burr, Manager of Research and Development for Datatrial. "We wanted to create something that would be easy to learn and use, worked with our existing database workflow and wouldn't require our users to understand databases or the technology."

Additionally, Datatrial needed their solution to meet strict EU regulations and the regulations of the United States Food and Drug Administration (FDA). Throughout the design process, Burr and his
team defined their ideal solution in terms of functionality, usability, integration and opportunity costs. Although reporting was widely available, the Datatrial team was uncertain that reporting vendors could fulfill their specifications. Building that functionality on their own, however, had its own set of risks.

"Building a reporting system internally would have split valuable time and resources," said Burr. "We would have needed to hire additional people to do the work."

Burr's primary concern, however, was the overall quality of the system. "Building internally would have forced us to concentrate on the development of two products rather than one. We wanted to focus our development resources on our EDC solution. We did not want that product to suffer."

The Solution

Not wanting to split resources to develop two products, Burr's team began an exhaustive search for reporting tools that could meet their specifications. After considerable analysis, Burr found that LogiXML's Logi Ad Hoc Reporting was a perfect fit.

"The developers at LogiXML had already developed my ideal solution. LogiXML's Logi Ad Hoc tool is built on XML and deployed across the .NET architecture, which made it easy to integrate into our solution. Its Web-based wizard connected directly to our SQL server database."

And LogiXML's Logi Ad Hoc helped Datatrial create an intuitive and complete system for their end-users.

"Single sign-on was an important aspect of the tool integration. We didn't want our clients to manage multiple passwords and sign-ons and we didn't want to force them to interact with multiple interfaces. Using Logi Ad Hoc, we created a seamless and transparent system for our users. The Logi Ad Hoc Wizard was
especially valuable and the entire process was remarkably easy."

Burr and his team easily integrated the single sign-on functionality into their application.

"Integration of the solution was done by replacing the default.aspx page with a simple page that read the username and password from our system and submitted a login request to Logi Ad Hoc. Logi Ad Hoc then handled the rest of the security. We wrote a little extra code into our user creation and maintenance forms so that users created in our system were replicated to the Logi Ad Hoc system as well. It was a simple process."

Adding Datatrial's own look and feel was easy as well. "Adding our brand elements to the solution was exceptionally easy. It only required adding one or two style sheets. It didn't require any time."

The Results

Integrating Logi Ad Hoc into the EDC system saved Datatrial significant time and resources and gave them the needed functionality to create a complete, user- friendly solution for their end users.

"Integrating Logi Ad Hoc was the right development and business decision," said Burr. "Logi Ad Hoc is easy to use and it was an excellent fit for us right out of the box. When we requested customization, LogiXML's support team worked closely with us to ensure that the product met all of our specifications. Their attention to us was exceptional and they delivered our desired changes within a week."

Andrew MacGarvey, Business Development Director for Datatrial, added, "LogiXML has worked closely with the team here at Datatrial to deliver a solution that allows the user to very simply report on their data. Not only is the tool intuitive, requiring minimal training, it is also very powerful. This is a great combination allowing Datatrial customers to browse clinical data or generate standard reports against any database that might be storing their data."