Adverse event (AE) management and regulatory reporting system, Argus Safety, is one of the upgraded pieces of software. Using the cloud-based software contract research organisations (CRO) can separate and manage safety data from a network of sponsors and partners.
"Developing version 7 of the product with Oracle has allowed Quintiles to establish a first for the life sciences industry, offering a validated end to end lifecycle safety solution which is available entirely as a cloud-based platform”, said Richard Thomas, chief information officer at the CRO.
New capabilities include: standardised configurations and rules management; centralised coding-dictionary management; and the ability to manage organisational safety priorities across all products.
Oracle is offering Argus Safety 7.0 on a Software-as-a-Service (SaaS) basis. Hosting the system off-site allows CROs to cut operational and information technology costs and requirements.
Biopharm is becoming more comfortable with SaaS and Oracle has responded by upgrading its system. Oracle Health Sciences Cloud has been launched to offer customers a “combination of scalability, data security, value, and confidence”, said Neil de Crescenzo, SVP at Oracle.
Clinical & data capture
Oracle has also made changes to how AEs are reported in its Data Capture software. Introduction of extended text fields, which use date and time stamps, allows for more comprehensive documentation of serious AEs and case histories.
Changes to Oracle Clinical and Thesaurus Management System have also been introduced. New features include dynamic case report forms (CRF) based on patient responses and progress.
"Clinical trial sponsors continue to seek new levels of efficiency and flexibility in setting up and managing trials”, said de Crescenzo. The upgraded software is easy-to-navigate and scalable, said de Crescenzo, allowing sponsors and CROs to increase clinical trial efficiency.