SafetyDrugs is a web-based application created to manage the whole cycle of Pharmacovigilance. It is powered by Oracle Database and build to ensure compliance with regulatory requirements, from clinical trial to post-marketing surveillance.

SafetyDrugs is specifically designed for small and medium companies because of its easiness in installation, use and validation process. In particular, SafetyDrugs offers a complete suite of validation documents that allows a fast and inexpensive start-up and an easy validation process.

Our technological partner is Oracle®, a world leader in Relational Data Base Management System market. It offers high level of performances, security and portability across different platforms. SafetyDrugs has been developed using Oracle Case®, thereof we have obtained a fast development of programs, screen and report standardization and low cost of maintenance.

Basic forms allow the management of the following parameters: Users, Access profile, Clinical studies, Dictionaries, Drugs etc.

In addition the main system functionalities include:

• Case Data Entry, the core section of the entire application, that allows the management of all acquired information about an Adverse Event or Clinical Trial.
• Reports and electronic reporting about adverse events that allow the expedited reporting to Competent Authorities as well as the issuance of all regulatory reports
• Cioms
• Psur (Line Listing, Summary Tabulations)
• XML Export-Import, for the automatic exchange of electronic information to/from Competent Authorities using XML file format.
• Workflow, modelled according to International Rules and internal requirements of your company.
• Business Intelligence system for queries and all type of data analysis about adverse events.
• Audit trail compliant to CFR Part 11 requirements.

The pharmacovigilance system has been developed to comply with EudraVigilance and 21CFR Part 11 policy and standard.

In particular SafetyDrugs has been assessed to be in compliance with the following regulatory rules:

• Directive 2001/83/EC requirements
  
• EMEA/H/20665/04/Final requirements for processing of safety messages and individual case safety reports
  
• 21 CFR Part 11 and ICH E6 requirements related to validation process and to the associated documentation and general features of System Security
  
• ICH Topic E2B and Topic M2 requirements related to the type of data that a Computer System used in Drug Safety Unit must manage and related electronic transmission.
  
• ICH Topic E2C requirements related to the extraction of the ADR information that a Computer System used in Drug Safety Unit must assure.

 In addition, Max Application offers SafetyDrugs in SaaS (Software as a Service) modality.

Your company will be charged only a periodic fee for the sole use of the pharmacovigilance software and Max Application will supply:

• hardware and software infrastructure (server, operating system, software etc.)
• security and reliability of your data
• antivirus, firewalling, service redundancy, electric backup etc.
• daily data backup.

So your company has nothing to worry about: your data will be available 24/7.

Download a copy of the brochure.