Regulatory Master Data Management – Bridge the gap between compliance, technology and science

By 19. October 2015Blog

Digital transformation is a hot topic. When applied to health products development, being able to combine science and technology – more specifically knowledge of data processing – becomes more and more important.

Back in the summer, Google and Sanofi joined forces on diabetes monitoring and treatment. Google’s health care research unit agreed to work with Sanofi on new ways to monitor and treat diabetes. Sanofi and the life sciences team at Google will combine their respective expertise in science and technology to work on better ways to collect, analyze and understand multiple sources of information impacting diabetes. The hope is that it will be easier for patients to successfully manage their diabetes, which would reduce the risk of complications, improve outcomes and ultimately lower costs.

Single Source of Regulatory Truth

For regulatory, digital transformation means linking regulatory systems across all departments within an organization. The objective is to integrate these data, be able to efficiently share regulatory information between a parent company and its affiliates, automate processes.

By structuring their regulatory data, organizations will become more efficient and responsive. Time to market is critical to more rapidly provide innovative, efficient and safe treatments to an increasing number of patients, in compliance with the ever changing regulation.

How can a Regulatory Master Data Management Approach bridge the gap between compliance, technology and science? By creating a centralized master data management platform, organizations can have a complete view of their key business data. It requires the collection of many different data categories coming from pre-clinical, clinical, CMS, manufacturing sites, external partners but also many different data sources such as in-house databases, regulatory information management system, regulatory and pharmacovigilance softwares, ERP (Enterprise Resource Planning) system. In addition, these data have to be combined and synchronized with data from official sources (e.g. agencies, official databases).

Regulatory Information Management System – RIMS

One of the main drivers of a regulatory master data management platform is reuse. The same information is shared across multiple applications. The ultimate result is a single source of truth for the regulatory data.

Agility and automation are key to achieve this. As regulations, business rules and internal processes constantly change, a next generation software should be able to adapt to these changes in real time. It should also be scalable to grow with the business.

Selecting stand-alone software addressing one specific regulation change will prevent organizations from benefiting of cross-functional benefits, increase the cost of compliance and minimize the ability to focus on innovation. Investing today in technology will enable organizations to save millions in the future as ever changing regulations continue evolving.