Full regulatory compliance.
etrials’ Trial, Site and Patient Intelligence systems were all developed in accordance with the requirements identified in the FDA’s 21 CFR Part 11 and Guidance for Industry: Computerized Systems Used in Clinical Trials. In addition, etrials ensures that it complies with ICH Good Clinical Practice guidelines.
etrials’ systems are validated per guidelines set for "Software Validation" provided by the FDA and through the SOPs in effect at etrials for software development. Validation of the systems includes verification of reliability, accuracy and consistency with defined user requirements.
We make it a top priority to ensure that our technology components comply with industry standards and guidance. After several external reviews by industry representatives, etrials has established a compliance statement to document how its offerings comply with these standards.
The etrials’ integrated platform of technologies (etrials’ Synchronized Intelligence Solutions) offer several excellent solutions for assuring that patient confidentiality is maintained, while also allowing sponsors to access needed data. User access is limited to authorized individuals. Each user is designated a role to determine the level of access granted within the system. System access is protected by using user IDs and passwords and by limiting access based on the privileges accorded to the user logging into the system.