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Integrated Solution 

Total Site Solution

Sites have told sponsors for decades that they want to focus on the patients/subjects, and not paperwork. However, it is the paperwork that defines the data, and the quality of the regulatory submission.

PharmaVigilant's Integrated Solution is the first total solution that leverages the latest technology. All of the system modules can function as a totally integrated solution, or independently, and interoperable with other systems. The modules are configurable, so as that as your needs evolve, so does the system. below is a chart outlining the system, and its integration.

 

Portal - PharmaVigilant uses single and double portals as the gateway to our modules and integrated solution. It can be used as a standalone, or imbedded into your current portal.

 

I-Vault PM (Project Management) -   Enables organizations to standardize their project management process. Documents, time sensitive events, and workflow are all managed by the system, enabling quality and consistency to be achieved regardless of the tenure of the team.

 

CTMS - The system is the first integrated configurable system. Key Performance Indicators will change with the type of trial, therapeutic area and over time as certain KPI's (enrollment) lose importance as they are achieved. PharmaVigilant's CTMS enables users to configure their CTMS solution to meet the needs of their trial or program.

 

I-Vault eTMF- is the most robust, configurable and expandable system on the market. I-Vault enables all parties working on a trial to use their own standards (naming conventions), while maintaining an overall master standard. The system has a robust reporting system with some of our sponsors running in excess of 500 reports on a single study. The system is also integrated into our CTMS system, and Cross reporting system.

 

EDC - The EDC system has integrated a full safety system, IWRS, Drug Accountability, and Site Payment system ensuring that study conduct achieves the highest level of quality and compliance.

 

Cross Reporting Engine - Is a robust drag and drop reporting engine that enables end users to run unlimited ad hoc reports either on single trials or multiple trials. Trial data from other vendors/data sources can be uploaded into the engine, enabling users to run reports on all of their in-house data, regardless of the source.  

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