OneClinical™ - Clinical Data Solutions and Services

OneClinical - Clinical Data Solutions and Services The ultimate product of any clinical lifecycle management endeavor consists of Regulatory-grade data delivered in a Regulatory-compliant format. Under our OneClinical™ brand, TAKE Solutions Global Life Sciences brings together a comprehensive suite of products and services to facilitate managing the clinical data lifecycle from data management to analysis, submission and archiving.

Today, we deliver 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 with the end goal in mind, which is ultimately submission of results from clinical studies in marketing applications to support regulatory review and approval.

OneClinical™ Vision

Our vision for OneClinical is to provide life sciences customers with a single source for both clinical data services and regulatory-compliant technology solutions. The coupling of FDA-compliant information management processes and technologies with rich clinical data lifecycle domain experience provides the foundation for our success.

Our in-depth understanding of the clinical development process combined with knowledge of industry data standardization initiatives allow us to overcome the challenges of managing the data lifecycle in a highly stringent regulatory environment.

OneClinical offerings include but are not limited to the following:

Consulting services focused on implementation of clinical data standards for sponsor process enhancement and preparation of compliant clinical data.
Products focused on enabling and facilitating data standardization.
Services focused on leveraging the standardization process into Clinical Study and Summary (ISS/ISE) reports.