FDA Expands Use of Convera Search Technology for Drug Review and Approval Process
Convera, a leading provider of search and categorization software for enterprises and government agencies, announced expanded use of the company’s RetrievalWare search technology by approximately 2,500 scientific review staff within the Center for Drug Evaluation and Research (CDER) at the FDA. The FDA’s CDER uses RetrievalWare for enhancing scientific productivity during drug regulatory responsibilities, prior to drug approval and for post-marketing surveillance of drugs.
Recently RetrievalWare’s use was expanded to provide easier access to an even larger breadth of research related libraries, including data from the Office of Generic Drugs and the Division of Counter-Terrorism.
Within CDER, RetrievalWare’s enterprise search capabilities are instrumental in helping drug reviewers identify precise drug related details within FDA generated correspondence and within massive libraries of documents related to pharmaceutical submissions.
Under time constraints for reviewing data, CDER’s scientific staff use RetrievalWare to extract specific information quickly during the extensive evaluation and approval process. In addition to other search functionality, RetrievalWare provides full content searches within PDF, XML, text and HTML documents, enabling reviewers to efficiently:
— Find prior drug product information, including previous FDA drug reviews and correspondence or documents
— Identify other similar drug products, which may already be available or awaiting approval
— Research across a set of drug product data for the probability of drug interactions
— Determine if pharmaceutical companies are complying with government regulations involving marketing, labeling and safety.
An essential component of the drug review process, the Adverse Events Reporting System reports on patients that have experienced adverse medical reactions to drugs. Integrated with the electronic data from this system, RetrievalWare also searches the system’s 3 million reports, allowing reviewers to quickly and easily pinpoint adverse human reactions. RetrievalWare also helps reviewers find associated drug details required during drug submission reviews, as well as identify problems with drug products already being marketed.
“Chemists, statisticians, drug safety evaluators, quality assurance specialists, medical officers, microbiologists, pharmacists and pharmacologists are some of the CDER staff that depend on RetrievalWare to identify precise research data from their search queries within CDER’s enormous libraries,” said Helen Mitchell, Product Manager, Enterprise Search, CDER/FDA. “The ability provided by Convera’s technology to perform full content searches and/or metadata searches has helped improve the quality and timeliness of the drug review process by helping facilitate quicker access to details our reviewers rely on for drug evaluations.”
About CDER
FDA’s Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. CDER evaluates all new drugs before they are sold, and serves as a customer watchdog for the more than 10,000 drugs on the market to be sure they continue to meet the highest standards. For more information, please contact CDER at 301.827.4573, or via the Web at www.fda.gov/cder
About Convera
Convera is a leading provider of mission-critical enterprise search and categorization solutions. Convera’s RetrievalWare solutions maximize return on investment in vast stores of unstructured information by providing highly scalable, fast, accurate and secure search across more than 200 forms of text, video, image and audio information, in more than 50 languages. More than 900 customers in 33 countries rely on Convera’s search solutions to power a broad range of mission-critical applications including enterprise portals, knowledge management, intelligence gathering, profiling, corporate policy compliance, regulatory compliance, customer service and more. For more information, contact Convera at 800-788-7758, via e-mail at info@convera.com or on the Web at www.convera.com .
This release, including any statements from Convera personnel, contains statements about Convera’s future expectations, performance, plans, and prospects, as well as assumptions about future events. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including without limitation, business and economic conditions and trends; continued success in technological advances; possible disruption in commercial activities caused by terrorist activity and armed conflict, such as changes in logistics and security arrangements; reduced customer demand relative to expectations; competitive factors; and other risk factors listed from time to time in the company’s SEC reports. Actual results may differ materially from our expectations as the result of these and other important factors relating to Convera’s business and product development efforts, which are further described in Convera’s filings with the Securities and Exchange Commission. These filings can be obtained from the SEC’s website located at www.sec.gov . Any forward-looking statements are based on information available to Convera on the date of this release, and Convera assumes no obligation to update such statements. The Convera design logo and the following are worldwide trademarks of Convera: Convera(TM), RetrievalWare(R), and Screening Room(R). The names of actual companies and products mentioned herein may be the trademarks of their respective owners.
