TrialStat Corporation , a clinical data management on demand company, today announced the availability of the industry’s first browser-side encryption module for hosted EDC. The new patent-pending encryption module for ClinicalAnalytics (CA) 3.0™, the company’s on demand EDC platform, consists of a customer-managed security key that is used to encrypt and decrypt specified data fields before they are sent from a web browser to a hosted server. The module’s encryption process, which is transparent to researchers entering data, completely obscures highly sensitive data elements, such as health card numbers, so that only users who created them and colleagues at different research sites can view their details. This enables researchers to capture highly sensitive data elements, such as patient names, while satisfying the privacy and security requirements of regulatory and ethics bodies for such data.

“The browser-side encryption module for CA is a significant evolution in data security for hosted EDC and has been driven by the needs of our customers to create a more secure operating environment to manage their clinical trials,” said Peter O’Blenis, Vice President Product Management, TrialStat. “In addition to our compliance with industry best practices for securing and managing clinical data, TrialStat now gives customers the ability to prevent specified data fields from reaching our servers in a readable format. End-to-end encryption completely satisfies our industry’s most stringent regulatory requirements and gives researchers the ability to collect highly sensitive data that might otherwise be disallowed by regulatory and ethics authorities.”

HOW IT WORKS – BROWSER-SIDE ENCRYPTION FOR EDC

All web-based EDC platforms use standard browser security to encrypt data during transmission between the browser and the server. Once data reaches a hosted server, most organizations employ industry best practices to ensure that the data is then stored in a secure and fully regulatory compliant fashion. TrialStat, for example, is in compliance with industry security regulations, which include 21 CFR Part 11 (Electronic Records, Electronic Signatures), part 820 (Quality System Regulation), parts 50, 54, 56, 312, 314 and 812 (Good Clinical Practice), PIC/S (Good Practices for Computerized Systems in Regulated “GxP” Environments), ISPE Good Automated Manufacturing Practices v4 and ISPE Guide for Validation of Automated Systems.

TrialStat’s encryption module goes beyond standard security practices by ensuring that data in specified fields is fully encrypted before it ever leaves the browser. The module has user-administered electronic security keys to ensure that only researchers who create the data can access it in a decrypted format. The module provides end-to-end encryption because there is no point during the transmission or storage of the data where it is ever readable without the key that was used to encrypt it.

CA 3.0 is an integrated web and handheld-based EDC solution that enables users to design, configure and manage clinical research projects themselves through a browser interface. This secure, cost-effective approach accelerates project startup, site addition and management, recruitment monitoring, query resolution and final data analysis.

ABOUT TRIALSTAT
Headquartered in Ottawa, Canada, TrialStat is a privately held company that delivers clinical data management on demand by combining its full suite of data management services with the company’s software as a service products. CA 3.0 is a robust and scaleable clinical EDC on demand solution used by leading academic and contract research organizations. SRS 3.0™ automates systematic reviews using real-time collaboration and management tools to achieve transparent, auditable and reproducible results quickly and cost-effectively.

ClinicalAnalytics 3.0 is a registered trademark of TrialStat Corporation.
SRS 3.0 is a registered trademark of TrialStat Corporation.