In order to reduce costs, maintain market share and increase revenue, pharmaceutical, biotechnology and medical device companies face increasing pressure to bring new drugs to market in the shortest possible time. To respond to the largely unmet need for products for an aging population and for the treatment of chronic disorders and life-threatening conditions, research and development expenditures have increased as a result of the constant pressure to develop and patent new therapies. The advent of government induced health care reform and the continued expansion of managed care providers and insurance carriers have made those parties major participants in the delivery of pharmaceuticals along with pharmacy benefits organizations. These companies are seeking to lower and control the prices of drugs and devices. Competition from generic drugs following patent expiration has resulted in increasing market pressure on profit margins and a corresponding need for new drugs to generate blockbuster revenues to the pharmaceutical and bio-tech markets. Recently enacted regulatory requirements have led to an increase in the volume and quality of data required for regulatory filings and escalated the demand for real-time, high-accuracy data collection and analysis during drug development & marketing.

A significant benefit of developing new indications is the ability to extend patent protection for products already approved by the FDA. To help cover the costs of the aforementioned demands and to also deliver a return to shareholders, there is substantial incentive on the part of the pharmaceutical and biotechnology drug and therapy owners to expand the scope of FDA approved treatment indications for their already approved therapies.

Spotfire addresses these challenges by enabling actionable decisions that enhance patient safety, streamline operations and enable faster launches leading to better medical outcomes for the patients and financial outcomes for the pharmaceutical industry. Spotfire empowers clinicians and managers to perform exploratory data analysis and informal clinical review of safety and efficacy measurements via predictive and descriptive modeling, forecasting, optimization, simulation, experimental design and more. Simple , easy to use visualizations allow the uniquely human capability of visual pattern recognition to make optimal and timely decisions.

“The clinical graphs our staff is producing are being used by GSK statisticians, clinicians and publishing staff in several critical areas including data analysis, presentation, submission and publication.” 
Dr. Roger Liddle, Discovery Biometrics Vice President, GSK

• Monitoring and Review:  Fast medical review of in-stream clinical data using a unique clinical data analysis method provides relief to busy clinicians, data managers, monitors, and project managers allowing them to focus on the bigger questions at the heart of a trial.
  
  
• Trial Operations:  Spotfire’s dynamic, visual review environment where live clinical and operational data can be combined and analyzed together via dashboards showing key performance indicators (KPIs) including trial enrollment and site performance with drill down to root-cause understanding enables an optimal pay for performance relationship with various outsourced providers, clinical sites and investigators.
  
  
• Safety and Pharmacovigilance: TIBCO Spotfire Clinical including Spotfire interactive visualization and S+/R predictive analytics - enables proactive, responsive decision making, rather than retrospective tracking of results.