Sierra Scientific Software Uses Logi Info to Improve Time to Market, Bolster Developer Productivity and Reach Users More Effectively with Secure, Web-based Clinical Research Software for FDA-regulated Medical Products Industry

About Sierra Scientific Software

A wide range of professionals contributes to the multiple phases of medical products clinical trials. Clinical Research Associates, Clinical Operations Managers, medical officers, investigators, and materials managers each use data management systems to input and extract information relevant to their specific job functions throughout a trial.

Current data management systems for clinical trials management, however, do not interconnect, creating data silos that hinder information dissemination and querying across the multiple functions of the clinical trial. The incongruency of these systems often results in inefficiencies in managing and closing out studies and often delays the identification of problems within the trial.

Sierra Scientific Software Inc. (Sierra) designed its Clinical Research Information System (CRIS) to provide a single solution to these technical and practical issues. CRIS, the first truly integrated, fully interactive, Part 11- compliant clinical research enterprise software package for the FDA-regulated medical products industry captures, archives and reports on realtime data across the entire clinical trial.

As a complete solution for the clinical research enterprise, CRIS provides a single repository for all of the data collected throughout clinical trials and enables enhanced decision-making by giving users the capabilities to access, explore and analyze data as needed.

The Challenge

David Thomas, CEO of Sierra, recognized the value of pushing CRIS to the next generation of clinical research management solutions by making it Web-based. Prior to version 8, CRIS was a client-server application with limited Web-based reporting and analysis functionality. Thomas, whose career has been centered on the continual improvement of clinical trials processes, recognized the significance of providing Web-based reporting and analysis tools to various clinical trials researchers and managers.

"To achieve maximum efficiency," said Thomas, "all relevant trial information needs to be readily available to the entire spectrum of users in clinicalresearch. These users need to be able to interrelate information easily and the system needs to be configurable to provide active surveillance of the data by alerting users of unexpected or unacceptable variances in specific data elements."

"All of this information needs to be secure and its integrity intact and the user interface of the system must be intuitive; otherwise, people won't use it. Users are located in multiple locations and, until now, they have been unable to gather and use data from a common source. Making CRISv8 Web-based let us connect these various users to the data that they need to get their jobs done efficiently."

The CRIS development team identified the technical and user requirements needed to bring a fully Web-based CRISv8 to market. Due to the nature of clinical trials data, the development team needed to create or find a secure solution that facilitated real-time reporting on large amounts of data quickly. The quality of the Web-based reporting was also a major factor.

"Our challenge was focused around moving CRIS from the client-server world to the Web world while adding significant functionality," said David Thomas. "The reports needed to be highly interactive. We wanted to deliver personalized dashboards and portals for various user types. We also hoped to find a tool that made reports easier to develop and maintain."

The CRIS team was also concerned about the usability of the system. Knowing that the majority of their end-users were non-technical users with limited IT support, the CRIS team doubted that an out-of-the-box reporting solution could be intuitive as well as comprehensive. "Putting data into a system isn't valuable unless you can get that data out easily," explained David Thomas. "The people who use CRIS ask 'what if' questions and carry out exploratory data-mining. They should be able to do these tasks interfacing directly with the data without the need for an intermediate programmer."

The Solution

After an exhaustive search for reporting and analysis tools, the CRIS development team chose LogiXML's Logi Info as the perfect tool for CRIS's reporting and analysis requirements.

"We knew that several companies claimed to have user friendly reporting and analysis tools," said Dave Thomas, "but in reality, those tools were very limited when it came to the kinds of reporting and analysis that were available to truly non-technical users. We looked at eight different vendors, everyone that you can think of, and decided that Logi Info was the perfect fit." The
CRIS team was impressed by Logi Info's .NETand XML-based architecture and its overall reporting and analysis functionality.

David Thomas explains, "Logi Info was the best fit for a number of reasons. The LogiXML architecture matches ours well, which helps us to make installations easier rather than more difficult. Eliminating this extra work appealed to us, of course. We also wanted one solution that could provide an easy way to develop customized dashboards and that provided a way to parameterize or tokenize reports so that the end-user could build their own reports and run their own queries. Logi Info provided that functionality within an easy-to-use development environment."

Logi Info also provided the customization that the CRIS team needed to deliver the best value to their end-users.

"Everyone in the clinical trials process uses a system differently," said David Thomas. "There are multiple work flows, responsibilities and needs. All are highly variable and it is critical to be able to design for these different uses. LogiXML's Logi Info is highly configurable and allows us to very easily customize CRIS around
the end-user."

Logi Info's advanced security settings were another important advantage to the CRIS team. Knowing that multiple users would be interacting with data simultaneously, the CRIS team needed
a solution that granted access to data based on a user's roles and rights.

"Data security assurance and integrity are an important consideration for clinical research programs," said Dave Thomas. "There are stringent regulatory standards in clinical research
that make security a paramount issue. We needed a reporting and analysis tool that provided for overall data security and for security over the Internet. The architecture of CRIS provides fine-grained controls over user access through the allocation of specific rights. Logi Info provides this extensive security and ease of development and make managing security a simple process."

Given the complexity of the information generated in clinical trials and the myriad of decisions that must be made, CRIS developers wanted to ensure that their system would alert users to issues in the data and enable them to respond rapidly. Logi Info's scheduling and alerts functionality provided the capabilities that they needed to enable end users to act quickly in the event of notable changes.

"There are many contingent relationships in clinical studies and action around those issues must be taken in a timely manner," said Dave Thomas. "User-configurable alerts are an important feature of CRIS. LogiXML's Logi Info provides the functionality that allows users to define parameters and make notifications actionable. CRIS warns the appropriate individual about issues and the alert status is maintained until the problem is resolved."

Cost effectiveness was an additional requirement for the CRIS project. LogiXML's affordable prices and simplified licensing model (pricing per CPU on the Web server rather than per user) added another reason for Sierra to partner with LogiXML.

"We were lucky to find LogiXML," said David Thomas. "LogiXML's tools allow us to add powerful reporting and analysis to CRIS without significantly raising the price to the end customer. Some other tools would have forced us to pass significant cost on to our clients. We didn't want to do that. LogiXML gives us the functionality that we need within a price that is very reasonable for the value added."

Sierra's latest version of CRIS (version 8) was developed to address the data management problems that managers and users experience throughout the clinical trials process. Coming from the perspective of clinical researchers, the developers of CRIS designed the product around the issues most important to the organizations that sponsor clinical research. Key features necessary to address these issues include:

• Total integration of every step of the research process within a single solution, reducing the capital expenditures and training costs associated with multiple, nonintegrated modules
  
• Easy installation and maintenance procedures with full data migration, integration, customization and validation support
  
• Intuitive and user-configurable"digital dashboard" interface and functions for quickly bringing all trial participants, and an everchanging roster of new ones, up to speed and ready for work

The Results

LogiXML's Logi Info has helped Sierra Scientific Software improve its time to market, bolster developer productivity and create the
first complete, truly Web-based clinical research software package for the FDA-regulated medical products industry.

LogiXML's reporting and analysis tools made the impossible possible," said David Thomas. "We had a very short time frame. If we had tried to replicate LogiXML's tools ourselves, the investment would have been ridiculous. If we had chosen a different partner, the costs associated with development, integration, implementation and training alone would have made CRIS far too expensive."

"There is no question in our minds that implementing LogiXML added significant value to our solution. It was something that could be easily implemented in a very short time frame and a tool that gives us a distinct advantage in the market."

Thomas adds that LogiXML's development environment has made development easier for the CRIS team. "The beauty of LogiXML's development environment is its simplicity," said Thomas. "It is very easy to use. Report creation is efficient and the development process is much easier. We can build dashboards and portals easily. We have also begun building workflow elements using Logi Info, and the process is much simpler than it has been. We have seen notable improvements in the productivity of our developers since adopting LogiXML."

By integrating Logi Info into CRIS, the CRIS team was able to create the first complete Web-based clinical research management system for the medical products industry. "In the past, users had to gather data from multiple sources. That data was entered into different spreadsheets and by the time the user who needed that data actually received it, the original data in the various databases
had changed.

LogiXML's Logi Info plays a critical function in the efficiency of clinical trials management. Now, the various users within the clinical trials process have greater power over their data and can work more efficiently than ever before. For example, when a question comes in to a medical reviewer regarding a specific adverse reaction related to a particular study, that reviewer can now compare and contrast data in the database to determine if the same toxicity was found in other patients. The reviewer can access and analyze this data through a Web-browser from anywhere in the world. This is done in real time and the medical reviewer does not need to understand databases or have any technical understanding. He or she can simply run the query, investigate and find answers.