TIBCO Introduces Spotfire® Clinical to Improve Clinical Trials and Accelerate Drug Development

New Analytics Solution Integrates with Leading Clinical Development Systems and Supports Clinical Data Monitoring, Clinical Safety, and Clinical Operations Analytics

WASHINGTON - DIA Annual Meeting


16 June, 2010


TIBCO Software Inc. (NASDAQ: TIBX) today announced the launch of TIBCO Spotfire® Clinical, providing the only in-memory, analytics platform on the market that empowers clinical development teams to make smarter, faster and more accurate decisions. Through highly visual and interactive exploration of clinical data, Spotfire Clinical® will enable actionable decisions that enhance patient safety, streamline operations and accelerate time to market for new medications and devices – leading to better medical outcomes for patients and allowing life sciences organizations to achieve drastically shorter development cycles and faster approvals of new medications. TIBCO is demonstrating a beta version of the product this week at the 46th Drug Information Association (DIA) Annual Meeting in Washington, D.C., booth #218.

Clinical development teams can quickly visualize and interact with enormous volumes of operational, clinical and safety data in a single interface to support forward-looking decisions, rather than retrospective tracking of results. By leveraging the new integrated S+/R statistics and predictive analytics capabilities of the TIBCO Spotfire® Analytics Platform, users will be able to conduct advanced what-if scenarios and sophisticated analysis to gain key insights into data, without the intervention of IT resources or biostatisticians.

"We use TIBCO Spotfire software for analyzing and reviewing operational and medical data on all our clinical trials," said John Keilty vice president of IT and Informatics, Infinity Pharmaceuticals. "With Spotfire, all our clinical, safety and operational data are available in real time. This enables us to shorten the time between critical development gates, and to meet key milestones sooner while simultaneously managing safety risk."

With an outstanding track record of providing innovative analytics and visualization capabilities to the world's leading life sciences companies, including nine of the top 10 global pharmaceutical and biotech companies, TIBCO Spotfire helps customers achieve shorter development cycles and faster approvals of new medications and devices. Spotfire Clinical will provide powerful capabilities to support clinical teams, including:

Integration with Leading Clinical Development Systems
Spotfire Clinical will integrate out-of-the box with leading systems, including Oracle® Clinical and Oracle® Remote Data Capture. With these integrations, clinical development teams can leverage interactive visualizations and S+/R-based predictive analytics to rapidly explore their clinical data stored in the leading clinical data management and electronic data capture systems. Pharmaceutical, biotechnology, medical device and contract research organizations using Spotfire Clinical will be able to visually interact with and identify patterns and trends in their data, enabling decisions that will shorten the time between critical development gates and meet operational milestones more quickly.

Superior Clinical Data Monitoring and Review
TIBCO Spotfire Clinical will provide a centralized and integrated view of clinical, operational and safety data in a highly visual interface that lets clinical teams easily customize and share their findings through mashups, portals or interactive dashboards. Features will include:

  • New Web mashup application programming interfaces (APIs) will let users merge operational, clinical, safety and pharmacovigilance data to identify patterns or outliers in the data to support superior decision making.
  • Export visualizations to .PDF format or interact over the Web through the TIBCO Spotfire® Web Player, making it easier than ever for clinical teams to share important findings with key stakeholders.

Easily Perform Safety and Pharmacovigilance Analysis
Clinicians can detect, assess and understand adverse events leading to better prevention by integrating with various signal detection systems to mitigate risk associated with ongoing clinical studies. The speed and ease with which users can drill into the data – down to the patient level – and view various safety profiles using what-if scenarios empowers medical reviewers and clinicians to quickly spot adverse effects or remove patients from a trial before they are at risk. Features will include:

  • Integrate with various signal detection systems to mitigate risk associated with ongoing clinical studies.
  • Analyze Kaplan-Meier and cumulative incidence data streams using the built-in S+ and R compatibility of Spotfire Clinical, without the intervention of IT or biostatisticians.
  • Merge, visualize and explore adverse drug reaction information, case processing and other medical data within Spotfire Clinical to prepare for periodic safety update reports (PSUR).

Efficient Clinical Operations and Resource Management
Spotfire Clinical will empower clinical development teams with the ability to visually analyze operational data from clinical trial management systems to help identify and retain best-performing sites; understand recruitment patterns across different countries, sites and trials; and meet program milestones and manage costs.

"Prior to TIBCO Spotfire Clinical, there hasn't been an easy way for clinical teams to interact with, visualize and analyze data from multiple systems to support faster decision-making and predict more accurate outcomes. Providing advanced, predictive analytics is one of the powerful benefits of Spotfire in the clinical environment," said Ben McGraw, director of life science industry solutions for Spotfire, TIBCO Software Inc.

TIBCO Spotfire Clinical is scheduled to be generally available this summer. For more information visit: http://spotfire.tibco.com/spotfire-for-you/by-industry/life-sciences/life-sciences-analytics.aspx.


TIBCO Software Inc. (NASDAQ: TIBX) is a leading provider of enterprise analytics software for next generation business intelligence. TIBCO Spotfire products offer a visual and interactive experience that helps professionals quickly discover new and actionable insights in information. Distinguished by its speed to insight and adaptability to specific business challenges, Spotfire rapidly reveals unseen threats and new opportunities, creating significant economic value. Spotfire customers include industry leaders among the Global 2000 that have deployed Spotfire analytics to gain an information advantage over their competitors. For more information, visit http://spotfire.tibco.com.

TIBCO, TIBCO Software, TIBCO Spotfire, and Spotfire are trademarks or registered trademarks of TIBCO Software Inc. or its subsidiaries in the United States and/or other countries. All other product and company names and marks mentioned in this document are the property of their respective owners and are mentioned for identification purposes only.

Legal Notice Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of the "safe harbor" provisions of the federal securities laws. All statements other than statements of historical fact could be deemed forward-looking, including statements regarding the future release or capabilities of TIBCO Spotfire Clinical. Because these forward-looking statements involve risks and uncertainties, important factors could cause actual results to differ materially. These factors include: any unforeseen delays, technical difficulties or changes in technology and standards relating to the development of this new offering. Additional information regarding potential risks is provided in TIBCO's filings with the SEC, including its most recent Annual Report on Form 10-K for the year ended November 30, 2009 and Quarterly Report on Form 10-Q for the quarter ended February 28, 2010. TIBCO assumes no obligation to update the forward-looking statements included in this release.

TIBCO Software Inc.

Lloyd Berry

Public Relations

+1 650 846 8862