ICON was approached by a large pharmaceutical company to harmonise their numerous standards libraries into a single library to be used across multiple therapeutic areas. They turned to ICON’s dedicated Global Data Standards team to provide experts in data collections standards, SDTM and ADaM to lead the project.

The sponsor wanted their outsourcing partners to utilise this library to develop a study support model and a governance process for their standards, however they lacked the bandwidth and standards expertise to implement such a strategy on their own.

ICON provided the sponsor with a team of dedicated standards experts who worked with the sponsor’s functional representatives to create and release a library of harmonised standards. This core team developed a study support model whereby study teams could request additions and modifications to standards objects and a governance model whereby new versions could be approved and subsequently rolled into a new release of the libraries. A unit-based contract was developed for the continuous resourcing of the study support and governance models, and sponsor standards for tables, figures and listings, and ADaM compliant analysis datasets were developed. Efficient internal processes and technologies were developed to enable the sponsor to effectively manage their outsourcing partners.

ICON successfully developed a study support model whereby our standards experts provide ongoing support on eCRF and SDTM mapping specifications for all study specific content that cannot be created from the sponsor harmonised library. To date, we have completed more than 1500 support tickets. We provide strategic input on all the sponsor’s standards initiatives and participate as members of the sponsor’s standards governance committee.

We continue to support the implementation of rolling releases of new library versions to provide ongoing improvements to their standards library content. Since the original release of the harmonised library, we have released four new versions, including the incorporation of content from a new acquisition that already had standards libraries. These releases have subsequently grown the library to over 150 CRFs, with details for more than seven ADaM datasets, and 100 annotated tables and listing shells. We have allocated a dedicated resource that reports directly into the sponsor’s head of data standards to support technology strategy and we continue to provide programmatic support for various standards implementation projects.