A Solution for Clinical Research Organizations (CRO)

As a CRO it is imperative that you remain compliant with the changing government regulations. Dr. Scott Gottlieb, Deputy Commissioner for Scientific and Medical Affairs at the FDA, states, “The agency wants to shift its information exchange to an electronic platform because receiving information in a consistent electronic format would help FDA make more effective use of important drug information, especially in safety situations."
(http://www.fda.gov/bbs/topics/NEWS/2006/NEW01510.html) PharmaReady enables you to streamline your clinical trial process by reducing the time it takes to get results from physicians, researchers and sponsors, reducing your completion times.

The PharmaReady Document & Submissions Management Suite offers a fully integrated, regulatory compliant, web-based Document Management, Training Records Management, Structured Product Labeling, and eCTD Publishing Solution Suite. PharmaReady makes eSubmissions easy to understand, easy to use, and easy to manage.

Meeting Your Greatest Challenges

We know your ultimate goal is to conduct accurate and safe clinical trials. We make these goals easier for you to achieve by providing:

A Fully Integrated Solution: Buying solutions from different vendors at different times and piecing them together yourself can cause not only frustration for your staff, but unnecessary delays in getting your products approved, and ultimately poor results. The PharmaReady Fully Integrated Document & Submissions Management Solution Suite includes DMS, eCTD, SPL, and TRMS components all designed to seamlessly work together.
A Cost Efficient Option: Becoming and remaining 21 CFR Part 11 compliant can be a costly process. The PharmaReady product is specifically designed for organizations where ease of installation, ease of use, compliance, and affordability are the primary business drivers. Additionally, PharmaReady offers the lowest total cost of ownership in the market.
A System That Works For Everyone: Without a system that is easy to access and easy to use you can wind up with a product that your staff won’t use. PharmaReady is a web-based Document Management, Training Records Management, Structured Product Labeling, and eCTD Publishing Solution Suite. By offering you full and easy access via the web, you’ll be able to use PharmaReady at your office, overseas, and at any future offices you may have.

Learn more about the fully integrated, regulatory compliant PharmaReady DMS, eCTD, SPL, and TRMS solutions.

PharmaReady - Customers