An Overview :
- Argus Safety is a actually an “Oracle” product
- Its a leading off-the-shelf product for pharma covigilance
- It provides a comprehensive platform for Case Management & Reporting.
- The drug safety database is actually maintained based on data from multiple sources, and meeting the global compliance regulations
- The Motive of this product is to Improve Drug Safety and Risk Management
Drug Safety & Pharma-Covigilance highlights !!
- Bringing any Drug to the market and launching it is always a challenge.
- The launch is not that popular like any other marketing product. It is always under the hawk eyes of the critics.
- Drugs directly or indirectly affect the life of a person. It could be allergic, side effect or even death.
- Its the most complicated and risky process.
- The members involved in the process of drug safety are the corporation, government, laboratories, doctors and patients.
- There are stringent rules from the safety steps perspective, before giving a Green or a Go Signal.
- Safety and Security are the hallmark of an industry providing greater transparency to the drug safety
- If there are any Issues with any Drug that are identified at an early stage, it brings down the cost and risk incurred in fixing the drug and bringing it to market.
- Its just like finding the bug at a development stage of the project than waiting for the end user to come with the Issue as a Production BUG (in case of drugs the result could be the death of the user)
- There are many systems involved to validate and verify the data to the minute/granular level.
Why Oracle Argus Safety ??
- Oracle Argus Safety does the same integration an is an integrated system.
- Some of the striking features of the product are :
- Case Data Management
- Regulatory Compliances (based on geography and landscape)
- Event Management
- Business Workflow
- Data Exchange with other systems
- The product provides a very rich workflow base and a configurable UI.
- When we talk about the case of the different symptoms, after the intake of a drug/medecine, we cannot directly Issue a Law or rule out the product. A lot of research and time has been spent by scientists, for preparing the product. If there seems to be any pattern wherein we can predict that such and such group of people in this location are affected by the intake of the drug along with some other drug (as a reaction).
- This pattern recognition and the point where we can declare the drug as a “banned” is designed in the workflow within the Argus Safety Product.
- This workflow and pattern recognition built within the product helps in exporting the product as a vaccine or a drug in the market.
- It provides a single global repository or a database allowing the instant availability of a case where in the world a similar case has been originated.
There are different DRUG Dictionaries that are supported by the Product – making it a comfortable place for the people who have spent in the life sciences industry.
Its also considered as one of the most demanding products in the market by the pharmaceutical companies.
As a beginner!! – here was a quick highlight of the pharmacovigilance and the Argus Safety Product!!. veterans and professionals can pour-in their view points and thoughts!!
For some additional info checkout the blog(on lifesciences and Argus) by Venu Sir : http://vmallarapu.wordpress.com/2011/04/25/oracle-launches-argus-safety-7-0%E2%80%A6/
Happy Learning!! 🙂