The need for this has become prevalent particularly in 2015 and 2016 where a lack of control, an increase in functionality due to the adoption of standards and the decommissioning of a prime toolset has left pharma companies forced to make changes.
Statistical Computing Environments (SCE) are a core toolset for the industry to be able to develop, maintain, track, monitor and validate the output that is created in support of running of clinical trials, in an area that has been neglected for some time.
Chaucer continues to support the needs of our clients in this area including the implementation, change management and maintenance of the toolset. We have also aligned the needs of the client with the vendors (CROs) from a data, contract and process perspective.
Within our senior management team we have individuals who have built, deployed and managed the needs of SAS programmers and Statisticians over 20 years. This includes local environments, global systems (4) and have built the core capabilities of a CRO to also support workflow and portals. Our knowledge of ‘off the shelf solutions’ also gives us insights to support our clients in the selection process of this toolset and integrations.
A sponsor may transfer any or all of the sponsor’s trial – related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.ICH E6 GCP Guidance 5.2.1