March 12, 2007
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?
Phase Forward recognized some key trends and acted on a timely basis:
- Drug safety is a rapidly growing market of increasing significance to our customers. To address this need, Phase Forward acquired Lincoln Technologies in 2005. There are significant synergies between the two companies in terms of products, customers and our partner relationships. In addition, Lincoln's experience working directly with regulatory agencies, such as the FDA and the MHRA in the United Kingdom, provides unique insight into current and future regulatory needs and initiatives.
- Standards have become critically important in this market. In November 2005, Phase Forward announced that it had obtained Registered CDISC Solution Provider (RCSP) status from the Clinical Data Interchange Standards Consortium (CDISC) for supporting the organization's standards throughout its product suite and service offerings. Phase Forward was one of the first companies to obtain this status.
- We’ve also focused on interoperability issues. Phase Forward is currently working with CDISC initiatives regarding interoperability between electronic data capture (EDC) systems and electronic medical record (EMR) systems. In addition, our software complies with current Web services standards, such as those advanced by the Web Services Interoperability Organization (WS-I).
- Integration of various external data sources with our software is another key customer requirement. Last year, Phase Forward introduced the InForm Adapter module for our InForm EDC product. Through standards-based Web Services interfaces, the module provides a number of integration points that enable extensibility and workflow across the InForm platform and with other third-party software systems. This means that clinical data, metadata, and event information, managed through the InForm solution, can be used to drive extended processes across multiple business systems. For example, study data can be exchanged with business systems, transaction systems and homegrown or packaged applications.
- Business process optimization (BPO) also has emerged as a key concern for many customers. We added BPO to our services offering to ensure that customers can achieve optimal ROI. Our services team can assess current business processes and redesign workflow as needed. This can help customers achieve measurable results in short order by refining processes surrounding their clinical trial development life cycle.
- Site and user management are key productivity issues for customers implementing and managing trials with EDC. Phase Forward has developed a User Management Tool (UMT) to simplify trial set-up and ongoing management. This tool is helpful in defining roles, responsibilities, access levels and approved procedures for each team member. Another useful productivity tool is the InForm Portal, which allows sponsors to create an integrated information and content repository using only a Web browser. This tool includes an easy-to-use Document Publishing Module, which allows a portal administrator to independently design, configure and maintain the study portal. Users can get up-to-date communications on study status, project updates and alerts to sites.
What is your vision for the future of the life sciences market over the next several years?
Personalized medicine will continue to be a key driver in coming years. Several stylized drugs have already come to market that have been demonstrated to work better for patients with specific genetic profiles. Personalized medicine will require extracting useful information from large datasets to detect patterns, as well as the use of technology to predict how individuals with a specific genetic makeup will react to medications and treatment levels. Drug and product safety will become a market differentiator for biopharmas and medical device firms. Safety is important from a consumer perspective, but it’s also important to insurance companies, which seek to avoid catastrophic or chronic cases.
The use of predictive models in drug discovery will become increasingly important. This field is reaching a point where models can be used to help researchers make informed decisions during the early phases of drug discovery and conduct virtual screenings — which can help reduce costs and cycle times. Simulation models to manage resources applied in clinical trials will become more commonplace. These models can help to determine appropriate dosages, inventory levels in the supply chain and pricing. The clinical development process will extend beyond the traditional phases to include the full life cycle of a drug. Companies will increasingly need to focus on post market safety issues.
Companies are looking for ways to take advantage of their massive clinical databases from drug development from within flexibly integrated clinical data repositories, which can be explored with new data mining and data warehousing tools. This approach could yield big benefits for patients. The integration of data across enterprises, leveraged by business intelligence applications, will accelerate. These applications will help organizations to better synthesize data and improve decision-making.
What products and services does your company provide and what special capabilities do they offer the life sciences market?
Phase Forward provides life sciences companies of all types and sizes with award-winning technology products coupled with global services to automate and integrate the entire life cycle of their clinical development process. Our end-to-end solutions provide customers with the necessary means to track and monitor product efficacy and safety, while building their trials more efficiently and cost-effectively.
Phase Forward clinical data solutions include:
· Electronic Data Capture: InForm
· Clinical Data Management: Clintrial
· Applied Data Standards: WebSDM
Phase Forward safety solutions include:
· Clinical Trials Signal Detection: CTSD
· Strategic Pharmacovigilance: WebVDME and Signal Management
· Adverse Event Reporting: Clintrace
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?
We sell our technology indirectly via Contract Research Organizations (CROs) and Academic Research Organizations (AROs), which offer our products to customers as preferred solutions on a trial-by-trial basis. CRO and technology partners include: Cognos, Fujitsu, Harvard Clinical Research Institute, ICON, Quintiles, SGS, and Veristat.
What are your most exciting products and initiatives in development, and how will they improve life science research?
Iin general, we are targeting the simplification of the study design process, improving workflow at the stakeholder level and continuing efforts to integrate Phase Forward products with external applications.
Where do you see your company in five years?
Phase Forward intends to maintain a significant investment in R&D so that we can continue to offer our customers and partners industry-leading products. It’s difficult to match the breadth of our product offerings and the depth and breadth of our clinical data management knowledge and domain expertise. Our products and services have been used in over 10,000 clinical trials involving more than 1,000,000 trial study participants at over 260 life sciences companies, medical device firms, regulatory agencies and public health organizations. This gives us tremendous insight into the marketplace. We aim to fulfill our broader mission: to provide the end-to-end solutions our life sciences customers need to track and monitor product efficacy and safety.