March 12, 2007

Nextrials
James Rogers
President and CEO

How has your company adapted and responded to the changing economic climate in the past five years when so many other companies did not?

The key to our success over the years has been our emphasis on providing a solution instead of just software. Many of our competitors offer software but Nextrials recognizes that biopharmaceutical and medical device companies need more than just technology —they need a team with strong experience in clinical trials to help them apply that technology. Nextrials was founded by clinical researchers and our software, Prism, and our services reflect that heritage.

The strength of Nextrials’ product, Prism, is an additional reason Nextrials has flourished and been able to adapt to market changes. Prism is a robust e-clinical tool that combines CTMS, EDC, and safety reporting. It also provides integrated tools like inventory management and automated thesaurus coding. The beauty of Prism is its modular design that allows sponsors to select the features that meet a study’s specific need. By eliminating unnecessary features, sponsors are able to simplify the interface, reduce training needs and save money.

For the most part, Nextrials’ competitors focus on the larger pharmaceutical companies because of their larger research budgets. This has left the small- to mid-sized pharmaceutical, biotechnology and medical device companies in an underserved market. Nextrials’ marketing strategy is to focus on these companies because they are the industry’s innovators and, as such, they better appreciate the value of e-clinical tools. Nextrials’ ASP offering also makes it easy for sponsors to implement e-clinical tools on an as-needed basis, while Prism’s stability provides the dependability researchers require for clinical trials.

In summary, Prism’s design, the expertise of the company’s management team, strong customer focus, 99.999% uptime and SMB marketing strategy are competitive advantages that help insulate Nextrials from market and economic fluctuations.

What is your vision for the future of the life sciences market over the next several years?

The clinical research industry is coming to accept the efficiencies inherent in converting many of its paper-based processes into e-clinical processes, and this movement will continue and even accelerate over the next several years. The drive to get new biopharmaceuticals and devices to market quicker and more cost-effectively, the increased demands for pre- and post-clinical trials pharmacovigilance and more stringent government regulations will only increase the pressure on the life sciences market to adopt automated processes. As sponsors gain experience with e-clinical trials, they will realize that the benefits go beyond just faster time to database lock. The greatest value lies in faster access to their data. This gives them a head start in planning their next trial and provides them with earlier insights into potential safety concerns.

What products and services does your company provide and what special capabilities do they offer the life sciences market?

Nextrials’ flagship product, Prism, combines sophisticated clinical trial management functionality and safety reporting with electronic data capture in a single, integrated package. Its modular design allows sponsors to select the right combination of features to meet the unique needs of each clinical trial. Using a singular dataset, Prism extracts added value from clinical data by providing features including:

• subject randomization
• data management
• product safety reporting
• real time email notification
• inventory management
• thesaurus mapping
• laboratory data management
• project management portal

Many of the potential customers for Nextrials’ Prism do not have the IT resources to maintain systems in-house, so Nextrials’ ASP model is a good fit for their needs. While many companies want to move forward, they are still cautious. Nextrials’ per-project pricing allows them to test drive the software on a single project without the initial expense and commitment of an enterprise license.

Partnerships are an effective way to track life science advances and ensure that your company delivers timely products and services. Which life sciences companies or organizations have you partnered with or invested in and why?

Nextrials establishes partnerships to a) enhance the capabilities of the Prism product, and b) meet the particular needs of any given customer. To date, the company has strategic alliances with Cerner Galt and Vitalograph.

Cerner Galt is an international leader in managing risk through information. By integrating Nextrials’ Prism with Cerner Galt’s dsNavigator, Nextrials has established the industry’s first EDC and safety alert system that also quickly and accurately auto-encodes drug and event terms using MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug (World Health Organization). The result is a single solution for improved workflow and management of safety trends during investigational studies.

Vitalograph is a global leader in respiratory technology. Through integration with the Vitalograph Spirotrac Centralized Spirometry System, Nextrials’ Prism offers researchers timely access to pulmonary function data collected during clinical trials, improving workflow and safety within an investigational study.

What are your most exciting products and initiatives in development, and how will they improve life science research?

A key initiative scheduled for near-term release is the incorporation of the CDISC ODM model into Prism’s database framework. With this enhancement, all study databases will be ODM native, allowing for more efficient import and export of all types of clinical data. An added benefit is the enhanced capability to manage CRFs in multiple languages, allowing international sites to view forms in their native language.

Where do you see your company in five years?

More and more, sponsors are looking to merge all their clinical data into a single source — and they are selecting EDC systems to be that single repository. Over the next five years, Nextrials will expand its partnerships with other data vendors to facilitate the collection and consolidation of all forms of clinical trial data, from patient data and centralized ECGs to MRI and CT images. Nextrials will also grow its CRO partnerships to provide the service component of its e-clinical solutions.