SOLUTIONS | Life Sciences

PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. PharmaReady is specifically designed for regulated Life Science organizations where ease of installation, ease of use, compliance and affordability are primary business drivers. PharmaReady is available in both on-site and remote hosted implementations.

The PharmaReady Submissions Management Solution is designed specifically for management of SOPs, Work Instructions, Training Records, Submission Documents, and all other documents within business areas regulated by the FDA. PharmaReady is a regulatory compliant information management solution based on Microsoft Windows technology.

eCTD - Electronic Common Technical Document
Easily submit applications and documents in the FDA recommended XML format while supporting submissions life cycle management, role-based authoring and intuitive electronic content assembly processes.

DMS - Document Management System
Efficiently manage SOPs, Work Instructions, and other documents within regulated business areas

TRMS - Training Records Management
Seamlessly manage technical training and maintenance of file training records

SPL-PLR - Structured Product Labeling
Achieve immediate compliance as well as improve your entire product labeling process.

PharmaReady Hosting
With PharmaReady On-Demand there are minimal start-up costs with nothing to install on your site. No customer hardware or software is required.

Learn more at www.PharmaReady.com.

TAKE Life Sciences Clinical Information Systems team 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 with the end goal in mind, which is ultimately submission of results from clinical studies in marketing applications to support regulatory review and approval.

• 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.

To learn more email contact@TAKESolutions.com.