Automated and integrated drug safety database solution

Through its collaboration with Oracle Health Sciences, Sciformix is able to offer its customers a fully automated and integrated safety database solution, allowing easy reporting and analytics for improving the quality and efficiency of drug safety operations

Sciformix partners with Life Sciences clients to provide a full range of services including safety and risk management, clinical development, real world evidence and market research, scientific writing, regulatory affairs, and technology services.

The Life Science industry is facing ongoing change with mergers, acquisitions and increasingly complex regulations, along with the pressure of doing more with less.

As a result, organisations have to develop strategies to manage divergent priorities to implement cost-saving measures while keeping a keen eye on innovative technology solutions that address growing compliance and data analytics needs.

Rapidly growing organisations, with complex safety needs for clinical trials, often lack the necessary technology and scientific knowledge and look to partner with specialised solutions providers to manage their safety data.

In addition, well-established companies are looking to increase efficiencies and compliance in the area of post-marketing surveillance. Many of these companies address this by turning to service providers who offer end-to-end solutions so they can focus on their core competencies of developing medicinal products.

In pharmacovigilance (PV), Sciformix provides adverse event processing services such as safety case intake, medical review of adverse events, regulatory reporting and proactive risk management.

Sciformix offers these services leveraging the Argus platform for both customers who utilise its PV services and companies engaging their own PV delivery model.

The Argus suite of software solutions enable compliance with E2B exchange standards for expedited reporting, allowing users to conduct global case processing that can scale up to many thousands of annual cases, while also improving reporting capabilities.

Fran Bates, VP at Technology Services, Sciformix Corporation, said: “Implementing leading technologies, such as Oracle Argus Enterprise Edition including the Oracle Argus Analytics Platform, will help companies manage their drug safety responsibilities with quality and easily manage any impending regulatory changes.”

“However, Life Science companies are often reluctant to embrace new technologies due to their perception of risks and costs associated with their adoption. This reluctance is no different in drug safety, but the latest technology being made available as a service minimises both risk and cost concerns.”

“What is unique about our full service offering is that it is end-to-end. Typically, vendors offer specialised services in one area, such as the technology platform, but not user, application and reporting services. Furthermore, Sciformix offers deep functional and domain knowledge that facilitates success in both implementing and managing the Argus drug safety technology platform.”

“Safety is paramount to the clinical research and development agenda, with advanced and robust PV processes and the quality systems crucial for new drug and therapeutic development. Use of a robust safety platform, like Argus, helps consolidate and integrate data across various systems into a single source, helping to track a drug’s real world impact,” said Bruce Palsulich, VP of safety product strategy for Oracle Health Sciences.

The Oracle Argus Platform offered through Sciformix enables companies to increase their visibility into their entire risk and safety continuum, including signal management, adverse drug event (ADE) trends, and performance analytics.

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