Medidata Speeds Process for Electronic Submissions to Regulatory Agencies.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--Oct. 15, 2003 Saves pharmaceutical and biotech companies time and money through a completely automated creation of fully bookmarked and hyperlinked electronic clinical report forms in PDF (Portable Document Format) The de facto standard for document publishing from Adobe. On the Web, there are countless brochures, data sheets, white papers and technical manuals in the PDF format. format Medidata Solutions, a leading developer of next generation electronic data capture (EDC EDC See: Export Development Corp. ) solutions for the clinical research industry, today announced a revolutionary new e-submission module, a fully-automated system for creating bookmarked and hyperlinked electronic clinical report forms (eCRFs) in PDF format - eliminating manual tasks and saving biopharmaceutical companies time and money when submitting clinical trial results to regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. . One of the most time-consuming tasks in the submission process to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and other regulatory agencies is organizing and presenting clinical trial data in a fully regulatory-compliant format. PDF technology enables sponsors to securely submit their CRFs and provides functionality including bookmarks, which help to organize the data in an easy-to-find manner, and hyperlinks, which provide instant connections between relevant clinical trial data - both of which are critical components in the process of preparing electronic submissions deliverables. Traditionally, sponsors were forced to spend days or even weeks performing these functions by hand or struggled to extract pertinent data from first-generation EDC technologies, slowing down the submissions process. Now, with this new module, Medidata is empowering sponsors with a solution that, in just minutes, automatically bookmarks and hyperlinks the eCRF PDFs - making the e-submission process more efficient and freeing resources to enable sponsors to focus on more strategic goals. "Our company was founded with the perspective that the existing processes and technologies in the biopharmaceutical industry could be greatly improved with a fresh, new look at traditional problems and through innovative technology," said Tarek Sherif she·rif also sha·rif n. 1. A descendant of the prophet Muhammad through his daughter Fatima. 2. The chief magistrate of Mecca in Ottoman times. 3. A Moroccan prince or ruler. , Medidata's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "With this new e-submission module we're allowing sponsors to spend more time on developing life-enhancing therapies life-enhancing therapy Clinical medicine Pt management–eg, use of antiretrovirals, narcotics for CA pain, or palliative surgery, intended to improve quality of life without an expectation that life will be significantly extended. Cf Life-extending therapy. and less on conducting administrative work. As we continue to add new functionality to our eCDM solutions, we further our goal of providing biopharmaceutical companies with the technology they need to get safe, efficacious ef·fi·ca·cious adj. Producing or capable of producing a desired effect. See Synonyms at effective. [From Latin effic products to market faster." Medidata's e-submission module provides the flexibility to enable sponsors to customize the appearance of eCRF PDFs according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. their own standards - while maintaining regulatory compliance. The product does not require a software upgrade to use, and is available immediately to current and new users of Medidata RAVE(TM), Medidata's proven, world-class EDC platform. About Medidata Solutions, Inc. Medidata is a leading provider of web-based data management solutions for clinical trials. The company's applications have been deployed successfully by world-class research organizations to collect and manage clinical data economically through a fully secure and compliant eCDM platform. Medidata's suite of applications streamlines the process of collecting, verifying and consolidating clinical research data, helping sponsors accelerate the process of bringing life-enhancing treatments to market sooner. Medidata solutions have been designed from the perspective of front-line clinical investigators to reflect real world practices, giving sponsors, investigators, monitors and data managers the earliest possible visibility to data for better decision-making. Founded in 1999, Medidata is privately held and based in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . More information is available at www.mdsol.com |
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