The main driver behind data standardization is often external and caused by regulatory demands specifically around the data submitted to the Health Authorities (e.g. CDISC, IDMP, eCTD, etc.). The need for data standardization is however not restricted to only involve adoption of industry data standards and to focus on the need to stay compliant. Data standardization also serves as a strategic component in adopting to the changing environment within the Life Science industry which is becoming increasingly data-driven.
A key goal with data standardization is to ensure that the data being generated can be used by machines and humans. To ensure this, the guiding principles to use is FAIR, meaning data is Findable, Accessible, Interoperable and Reusable. Having FAIR data is a crucial prerequisite for increasing operational efficiency through digitalization and ultimately gain more value out of the data.
Getting to the point of having an agreed set of data standards used by systems, processes and people in the organization can be a very challenging journey. Not only does it require the IT systems to “speak the same language” thereby making data transferable. It also needs an agreed and clear definition of what a given data standard means within an organization along with a transparent and efficient data governance model that ensures proper maintenance on the operational level.
Data standardization projects should include a thorough analysis of the current processes which generate and use the impacted data. This enables identification of pain points and opportunities and serves as a basis to detect the data flow gaps and define the future processes. All departments using the processes impacted by the data standards should be involved. To avoid the scope becoming too big and involving too many stakeholders, a staggered approach may be beneficial. This may be helpful when dealing with extensive data mapping and large migration tasks as a result of implementation of data standards.
Adoption of data standards may initially be faced with organizational resistance due to the lack of flexibility experienced when moving from an uncontrolled way of working. It is critical not to underestimate the importance of organizational change management to support the impacted stakeholders in adopting to the change and recognizing the value. Training in using the standards and showing the benefits downstream in the processes assures support by the organization. Anchoring the data governance high in the organization help enforce the standards.
One of the true game changers to be realized as a result of data standardization is the potential for usage of more advanced technologies as part of the digital transformation within the Life Science industry:
Without good data quality in place, none of these benefits can be realized. Data standardization is an essential piece in laying the foundations for enabling the usage of advanced technologies and will provide a competitive advantage Life Science companies.
At HERAX we support clients with implementation of data standards for the Life Science industry, as well as with internal data standardization projects (e.g. eProtocols, CDR, CDW, SCE, eCRFs, CDISC etc.). We can help you create standards strategies, optimize your processes and implement solutions required in order to support the data standards.
Cecilie supports clients from the pharmaceutical industry and has been involved in several projects across Europe and in Japan. She is specialized in process optimization and implementation of IT solutions with project experience from all main areas of R&D, from Early Research to Regulatory Affairs. During the last three years, she has gained extensive experience with EDMS implementation, Data Standardization, the Clinical Trial Regulation and Laboratory Data Management.
Cecilie has a strong background in biomedical research and holds a M.Sc. in Molecular Biomedicine.