5thPort Simplifies Adoption of eConsent Technology with
FDA 21 CFR Part 11 Compliance
Augusta, Maine (November 12, 2020): 5thPort, a healthtech company, announced today that its best-in-class, SaaS based Patient Engagement and eConsent Platform has been externally validated and certified as compliant with US FDA Regulation 21 CFR Part 1, European Commission EUDRALEX ANNEX 11 as well as applicable provisions of ICH-GCP and HIPAA.
The Arbour Group worked with 5thPort and applied more than 20 years of IT systems and software compliance expertise to complete the assessment and certification process. The assessment included verification of system functionality, audit trails, electronic signatures, and privacy and security requirements when using electronic informed consents in a regulated environment. Compliance with regulatory guidelines is a must for any company that supports the life sciences industry.
The 5thPort Platform is designed to be used by Contract Research Organizations, Clinical Research Sponsors, Research Institutions and other organizations involved in conducting clinical trials.
“Achieving compliance with the FDA and other regulations is a significant step in our evolution,” said Navroze Eduljee, Co-Founder and CEO of 5thPort. “Our platform helps clinical trials succeed by improving conversion and retention of participants while greatly simplifying the process of electronically obtaining true informed consents.”
This validation of the 5thPort Platform provides our clients with confidence to adopt our industry leading patient engagement and eConsent capabilities for their clinical trials and underscores our commitment to helping our clients satisfy their regulatory and audit compliance requirements.
About 5thPort LLC:
5thPort is a healthtech company focused on improving outcomes through better patient engagement. The 5thPort digital engagement platform engages patients and caregivers using easy-to-understand, high quality videos followed by simple comprehension testing. The platform includes a next generation informed consent process that is specifically designed to encourage a meaningful conversation with the provider. The multi-lingual capable platform streamlines office workflow, handling multiple procedure-based consents dynamically. Simply put, 5thPort puts the “informed” in “informed consent”. The platform supports both a remote engagement process and an in-office process. The entire patient encounter is “logged”, providing detailed date and time stamped documentation.
Navroze Eduljee, CEO