Safety and Risk Management

Integrated Drug Safety Technology Solutions

The Greatest Barrier and Opportunity to Innovation Lies in Technology

Technology has forever transformed the healthcare continuum and has ushered in new and revolutionary ways to ensure patient and consumer safety.  Technology has also enabled organizations to achieve higher levels of insight, quality, and efficiencies by driving down operational costs and rendering information in meaningful ways. IT has become the strategic foundation of worldwide pharmacovigilance operations, fundamentally altering the drug safety continuum.

One of the biggest challenges organizations face is how to effectively integrate the science behind all aspects of the product lifecycle with the technology know-how of IT.  Companies that recognize the importance of an integrated strategy that takes these two elements, along with the changing global regulatory landscape, into consideration will see greater success in managing the lifecycles of their products.

Infinity Symbol final

By combining our strength in the drug safety space with technology solutions and services, we offer companies a cost effective global model that will ensure the highest standards of compliance, quality and agility in reacting to change. Our solutions will help create the ideal environment for innovation and continuous improvement across the entire drug product life cycle.

Sciformix’s integrated drug safety solutions help life science companies build a Pharmacovigilance IT reference architecture, deploy signal detection applications and create enterprise portals for safety analytics. Additionally, we also provide solutions for business intelligence, analytics, querying and reporting, validation and regulatory compliance. This enables innovation and continuous improvement across the entire drug product life cycle and helps organizations to be more pro-active in their ability to respond to problems and business needs.

Our Integrated Technology Approach

Sciformix offers a full life cycle approach to drug safety technology, across a Planning, Deploying, Managing and Analyzing spectrum, allowing our customers insights into their safety operations and the ability to spot health trends in a product’s patient population.

Integrating Technology & Safety Operations Flow Chart

 

Safety Cloud brochure

Sciformix, in partnership with Oracle, offers a full service validated private cloud single tenancy solution based on Argus technology which enables faster and better safety decisions. This automated and integrated solution allows for easy scientific querying and analytics which improves the quality and efficiency of
safety operations. It also enhances compliance with E2B exchange for expedited and periodic reporting, allowing the organization to conduct global case processing that can easily scale.

Download information on our Safety Cloud Solution. (PDF)

Accelerator Methodology Delivers Validated Argus Cloud in Record Time

By implementing a flexible and integrated team structure, best-of-breed IT QMS and virtualization methodology, the client realized a quality validated cloud solution in record time.  With an integrated solution the client achieved better consistency and control over their safety continuum, cost-efficiencies, and audit-readiness.

Download the case study on how our Accelerator Methodology Delivers Validated Argus Cloud Solution in Record Time. (PDF)