NNIT was invited as a consultancy company to assist a medium-sized pharmaceutical company in a pre-project with the scope of defining a change program for the optimisation of their clinical development.
After a preliminary phase, the overall vision for the program was formulated, high-level architectures were constructed and business cases were developed. After a selection phase, NNIT were invited to assist in the first of a series of projects, a foundation project with the scope of introducing CDISC standards for CRF and clinical databases.
The project had(s) two main tracks: 1) the actual, hands-on mapping of existing standards to the new standards (SDTM, ADaM) including the development of methods and procedures, and 2) the handling of the related procedural and organisational changes, ensuring the transition, and the development and introduction of standards governance, maintaining the standards.
The presentation at this conference will focus on the latter part, namely the OCM exercise, including the implementation of a standards governance organisation.