Medical Device

Medical Device

Medical Device trials are often considered less complex compared to drug development studies, but the reality couldn’t be further from the truth. Variance, for instance, represents a crucial complexity in these kind of studies, therefore protocol and study design become fundamental elements to achieve quality results.

Additional factors which may affect Medical Device studies are small populations, site differences and unique study endpoints.

Even more pressing is the legislation surrounding Medical Device trials. Both the EMA and FDA have updated legislations in place which require more data and post-market study follow-up. Medical Device companies need to collect more clinical and safety data to demonstrate safety and efficacy. In addition, they need to have the capability to prepare and present this data in a traceable and transparent way.

With increasing costs to stay compliant with industry and regulatory standards, there is no doubt medical device companies are facing tighter budgets.

user-friendly Electronic Data Capture solution

Conducting clinical studies requires Data Managers to collect large amounts of data. Symphony EDC is a fully validated, SaaS solution that is designed for independent study build and management with minimum training required. Arithmos also provides an integrated  eLearing platform to guarantee a proper and quick adoption of the tool by the users.

pre-designed, fully validated Pharmacovigilance

Argus Blueprint is a Pre-Designed and Fully Validated Solution for fast deployment of Oracle Argus Safety that allows companies to implement or change Pharmacovigilance systems in the most accurate, timely and cost-effective manner.
Argus Blueprint guarantees full scalability to adapt to business needs and the flexibility to provide a standard implementation with configuration ownership by the Client.

As an Oracle Gold Partner and Oracle Business Process Services partner, Arithmos can offer clinical applications in an optimum value package. Under the BPS approach, we help clients improve efficiency and productivity using a reliable technology infrastructure with access to an experienced IT team of Oracle General Product Support Specialists.

We offer the following Oracle clinical applications: Oracle Clinical & Remote Data Capture, Oracle Thesaurus Management System and Oracle Argus Safety.

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