That the regulatory process is becoming less document- and more data-driven can only be a good thing for Life Sciences organizations – as long as they take full advantage of the associated opportunities and develop strong strategies for data governance.
A whole raft of new data standards is coming through now, including IDMP, FMD, FDA’s PQ/CMC and Health Canada’s implementation of the Structured Product Monograph, not to mention operational changes on the regulator side, such as EMA’s implementation of SPOR. All of which is driving the demand for a new generation of regulatory information management (RIM) systems and platforms – those that can support broader, cross-functional activities with potential benefits for a wide range of stakeholders. Stakeholders who will use and understand the data differently in their respective contexts.
To ensure that all of these different teams have a common understanding of the data and contribute to its quality and reliability, companies must start as they mean to go on – with strict requirements for how data is managed. There is no point in organizations making substantial investments in the latest technology if they fail to match these with data process rigor, because the effectiveness and impact of those systems will depend directly on their content.
There are some clear barriers that need to be overcome to get to where companies need to be, however. Although operational people will have felt the pain of inconsistent definitions between different departments, senior managers haven’t necessarily experienced this, so they may be less aware of the benefits of being more data-driven in the management of regulated product information. Nor may they fully appreciate the scale of work ahead to: assess the current state of data; determine where authoritative original information resides; outline what needs to happen to bring everything into a more standard, consolidated format; and, finally, determine how this will be governed in future.
As long as data is recorded in different ways in different parts of the organization, companies have no hope of being able to work more efficiently and maintain consistent, good-quality data that can be accessed efficiently and confidently by the teams who need it to perform a given task. If, each time, they first have to chase and check data to ensure it is the latest, definitive information, they will see little benefit in any new systems. Meanwhile, the risk of entering inaccurate data into forms to be submitted to regulatory agents – and of this going unnoticed – has very real implications for market access/maintaining marketing authorizations.
Recommended practice includes involving the right people from across all affected functions and establishing a formal governance organisation with clear roles and responsibilities, as the data won’t govern them itself. Once this is done, it can be enacted to define what ‘good’ looks like, in terms of the vision and critical success factors, to guide the journey as well as the detailed data definitions, formats, and quality standards.
Doing this, keep in mind the whole point of investing in systems is to alleviate the administrative burden for time-pressed professionals. If you end up with five people maintaining data in five systems, then something has gone wrong. Certainly, it’s important to view this not solely as a compliance project – but also as a foundation for greater efficiency.
In a recent webinar, now available on-demand, Vanggaard goes further into "Data Governance, a Key Prerequisite for Realizing the Value of Next-Generation Regulatory Information Management (RIM)." Watch it now.
Need help taking this forward with your own team? AMPLEXOR can help, contact us.
Jens-Olaf Vanggaard is Director of the Research & Development Practice at HighPoint Solutions in Zurich, Switzerland. A senior Life Sciences R&D consultant, he has accumulated over 10 years’ experience within Clinical Development and Regulatory Affairs, implementing clinical data warehouses, metadata repositories, clinical trial management systems, and electronic trial master files. He also contributes proactively to the definition of the IDMP standards and guidelines, being a member of the EU IDMP Task Force Referentials sub-group, and is actively engaged in the development of IDMP tools and solutions.