Marlborough, MA (PRWEB) March 19, 2009
Datafarm Inc., a world leading provider of high performance electronic regulatory submission solutions for the Life Sciences industry, today announced that the company has achieved Registered Solution Provider status from the CDISC Technical Leadership Committee in three key areas relevant to electronic submissions including SDTM, ADaM datasets and define.xml.
CDISC (Clinical Data Interchange Standards Consortium) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. As life sciences organizations move towards improved process efficiencies through the implementation of CDISC global data standards, Datafarm guides and supports customers in a core principal of the CDISC mission; creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood, and navigated by regulatory reviewers.
Datafarm has over 10 years of experience in preparing clinical data for regulatory submissions and was the pioneer vendor in developing a Clinical Report Tabulations (CRT) application to help sponsor organizations submit their clinical data to the FDA adhering to CDISC and FDA requirements. Shy Kumar, CEO of Datafarm says, "We have always upheld the highest development standards meeting the requirements of the FDA and CDISC as these are critical success factors when preparing data for submission. Our services group includes some of the leading global experts on electronic submissions and CDISC standards and we are pleased to have been able to connect all the dots and obtain RSP status from CDISC."
S-Cubed® CRT solutions is the latest Datafarm family of products to support the CDISC standards and FDA requirements. S-Cubed CRT delivers study data in electronic format and creates the entire Clinical Data section of an electronic submission along with the define.xml (for SDTM and ADaM) and/or define.pdf (for legacy data) and SAS transport files.
In addition to software, Datafarm's Regulatory Services Group (RSG) assists sponsor organizations in converting legacy clinical data (legacy and ODM) to submission-ready, CDISC compliant SDTM and ADaM formats. RSG has recently completed data preparation projects for over 15 clinical studies which included verification of SDTM and ADaM datasets as well as creation of define.xml.
For more information on Datafarm's CDISC standard based solutions please visit: http://www.datafarminc.com/Solutions-CRT.aspx.
About Datafarm, Inc.
Established in 1997, Datafarm is a world leader in high performance electronic regulatory submission solutions for the Life Sciences industry. Datafarm's open, modular technologies and professional services experts enable Life Sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and compliance to efficiently deliver regulatory reports and submissions.
Datafarm has helped hundreds of sponsor companies compress the regulatory submissions approval process, improving speed to market, cost control and productivity in order to achieve their ultimate goal of ensuring patients' and physicians' timely access to new drugs.
As a total solutions provider, Datafarm employs some of the industry's pioneers in document-based software development as well as world renowned life sciences regulatory specialists who proactively work with customers and business partners to drive new initiatives and maintain a market lead approach to development and services. Headquartered in Marlborough, Massachusetts, USA, Datafarm has regional offices in California and Philadelphia in the US, UK, France, and India. Information about Datafarm's products and services can be found at http://www.datafarminc.com.
Datafarm and S-Cubed are registered trademarks of Datafarm Inc. All other product and company names mentioned herein are trademarks of their respective holders.
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