Take Solutions, a leading provider of global life sciences products and services, has developed the CDISC SDTM (Clinical Data Interchange Standards Consortium - Study Data Tabulation Model) standards. CDISC SDTM optimizes the process of transforming clinical data collection. It guides the end-user to easily profile, analyze and specify data mappings and also perform validation, feed-back and error-correction.
According to Ram Yeleswarapu, president and CEO, Take Solutions, the advanced technology and intuitive process will change the way bio-pharmaceutical companies adhere to regulatory standards. The new solution is a value-added OneClinical product. In 2006, the company invested Rs 15 crore for research and towards Intellectual Property creation including filing for patent.
The intuitive process seamlessly guides the end-user to easily profile, analyze and specify the data mappings, while also performing in situ and real-time validation, feed-back and error-correction. The emergent dataset is SDTM compliant and validated. Once validated, the datasets are packaged along with the Data Definition Document (Define.XML) to be submitted to the regulatory body as part of eCTD or RPS standards. Also, the standardized domains are utilized for Interim data analysis; Standards based clinical study reports (CSR) generation and clinical safety analysis portal.
The new OneClinical patent will be one of many technology patents held by Take Solutions both in the US and other countries. The patented technology incorporates the company's expertise in IT and e-Solutions space for the life sciences industry as well as its hands-on expertise with CDISC, he said.
OneClincal delivers a full spectrum of information management services and solutions leveraging industry data standards that help sponsors streamline the clinical data lifecycle. The centerpiece of our process is the CDISC (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model). We work towards submission of results from clinical studies in marketing applications to support regulatory review and approval. It offers an in-depth understanding of the clinical development process combined with knowledge of industry data standardization initiatives allowing customers to overcome the challenges of managing the data lifecycle in a highly stringent regulatory environment. .
Take Solutions has a range of products and services in Life Sciences and Supply Chain Management backed by strong domain expertise to provide cost-effective regulatory compliant business solutions. With more than 500 current employees, its life sciences base is headquartered in Princeton, USA. The company is also assessed at Level 5 of the Capability Maturity Model Integration (CMMI), Software Engineering Institute, Carnegie Mellon University, USA. It is a Microsoft Gold Certified Partner, a Charter Member of the Microsoft BioIT Alliance, and is a registered CDISC Solution Provider. It is working for customers spanning across 12 countries with more than 150 Fortune 1000 customers.