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International Clinical Trials

Automating Regulatory Data to Drive Digital Transformation

Data quality is at the heart of digital transformation. Yet, many life science companies are still failing to get up to date and find consistent data to talk to each other across integrated systems. The goal is not only to automate and integrate internal processes, but also to automate the sharing of that data with regulatory authorities, with the aim of speeding up the time it takes to get new or improved drugs to patients. Technology can help, but there are steps that pharmaceutical companies should begin to take now to improve interoperability.

Data are at the heart of regulatory processes in the pharma sector. Regulatory systems contain data on products and their licences. There is also procedural data, recording interactions with the authorities about a licence, from the initial application through to post-authorisation changes to the licence. Elsewhere, expert functions, from manufacturing to clinical teams, generate the basic data that feed the regulatory dossier supporting the licence. Typically, there is no direct communication between regulatory systems and expert functions systems. Manufacturing or clinical teams collate their data into a summary document and send them to the regulatory function. The regulatory team then takes those data and pulls them together in a submission dossier, ready to send to competent authorities for approval.

In manufacturing and the supply chain, the enterprise resource planning system typically holds data about products and materials. Meanwhile, in the regulatory function, there will be a regulatory information management system, which also contains data about the same products, but from the perspective of regulatory approval. Those systems are most often in completely separate worlds, with little or no interoperability. Yet, a change made in the manufacturing world must be reflected in the licence. Similar issues apply between the systems for management of clinical trials and the regulatory tracking of clinical trials applications.

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Duncan van Rijsbergen is Associate Director Regulatory Affairs at Iperion, a globally-operating life science consultancy firm, which is paving the way to digital healthcare by supporting standardisation and ensuring the right technology, systems, and processes are in place to enable insightful business decision-making and innovation.
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