The vast majority of drug safety case processing and regulatory reporting applications are licensed, commercial-off-the-shelf product offerings. These systems provide many of the features and functions that are necessary to run the core business, however no out-of-the-box application is able to suit the specific needs of any particular organization. Not only has this, but requirements, regulations and technology evolved over time, prompting new product releases that require periodic system upgrades.
As a consequence of adopting a best-of-breed approach to application adoption, as well as strategically avoiding single product vendor dependence and lock-in, organizations tend to turn to system integrator to both implement the individual functional systems, but also to develop the necessary interfaces and integrations between these applications, to facilitate the end-to-end process flows. A simple example would be the transfer of adverse events from electronic data capture to the core safety systems and the transfer of source files, attachments from safety systems to centralized document repositories.
Vitrana meets these challenges by providing expert consulting services to implement drug safety case processing and reporting applications, developing key integrations to support cross-platform process flows, and maintaining and upgrading the platform, both for on premise or hosted deployment models. The Vitrana team are pioneers in cloud deployments and have worked with clients across the world who have realized the benefits of lower cost, of rapid implementation, and of closer alignment to the product road-map whilst ensuring the highest level of information security and data privacy.