The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical has further enhanced its innovative clinical research technology solutions with the addition of Oracle Argus.
The implementation of Oracle Argus pharmacovigilance system is the latest addition to Avance Clinical’s state-of-the-art systems suite, supporting clinical trial management services.
Safety management and reporting is one of the most important aspects of early clinical development, an area of deep strength and expertise for Avance Clinical.
The addition of Oracle Argus complements the experience of Avance Clinical’s dedicated Safety & Pharmacovigilance team headed by Pilar Garzon who has over 12 years’ experience in clinical trial safety management.
“I am very excited to have Oracle Argus as our premier safety system at Avance. I have worked with this platform for several years and consider it to be the best tool in the field,” Pilar commented.
“Oracle Argus further enhances Avance Clinical’s safety management processes within a validated built-for-purpose framework providing automation and efficiency improvements to our existing workflow throughout at all stages of safety processing and reporting,” said Gabriel Kremmidiotis, Avance Clinical’s Chief Scientific Officer.
The Argus system is of particular importance for Phase II clinical trials involving patient populations where the observation of adverse events is more prevalent compared to Phase I healthy volunteer trials. Avance Clinical is increasingly in demand for Phase II studies so the Argus platform is an important addition the technology solutions offering.
“We are excited to welcome Avance Clinical to our global community of Argus customers,” said Bruce Palsulich, Vice President, Safety Product Strategy, Oracle Health Sciences. “Argus provides proven compliance with continuously changing worldwide regulations, and its built-in automations, integrations, and usability significantly reduce manual work and maximize efficiency. We are pleased that Avance Clinical has chosen to standardize on Argus for safety case management.”
Argus Cloud, the industry’s best-in-class platform for safety and pharmacovigilance regulatory compliance, offers a scalable and secure solution within a multi-tenant ICH E2B R3 XML compliant database for our clients.
As clinical research becomes more complex and spans regions with diverse regulatory requirements, it is vital to have a technology solution like Argus that can accommodate full safety and regulatory compliance on a single platform.