Mature organisations have their work cut out to migrate to new frameworks, whereas some smaller, more scientific companies struggle to support themselves with technology and processes just to be compliant.
We have taken our experience in the industry to build an out of the box technology framework that incorporates standard assets and integrations from mainstream, best of breed technologies, operating through an extremely efficient process.
This incorporates a metadata repository already loaded with CDISC standards, the choice of multiple EDC tools (but built from one toolset), the automated delivery of SDTM data and visualisation of real-time clinical data.
The model also can incorporate toolsets like eTMF that will be maintained throughout your trial period.
This can be complimented by the added value of our professional services partners to deliver a full service offering of data management, robust ADaM modules and Tables Listing Figures.
Our offering has matured through working with smaller clients to support their start-up organisations, but we can show value to large organisations that need to take their high priority products away from complex systems and processes. They can take advantage of a pure CDISC environment that benefits from many efficiencies and delivers higher quality.