Current Edition

Updating Your Regulatory Information Management Capability? It Could Pay to Get Hands-on

Letting business-savvy techies play around with a new RIM system ahead of the proposed implementation could save Life Sciences companies a fortune, says Romuald Braun, Managing Partner at MAIN5, warning against hasty vendor selection and contracting.

Everyone is time-poor now. So, when Life Sciences companies are looking to formalise or refresh their regulatory information management (RIM) capability, it is tempting to default to the leading brand. After all, if peer companies have already done the research to arrive at this choice, why reinvent the wheel?

Yet, a lack of rigour in the requirements definition and vendor selection process could invite considerable risk and additional cost, if something important has been overlooked. As the EU IDMP grace period gives way to a hard mandate for data standards compliance, and as digital transformation ambitions expand beyond the Regulatory remit to encompass Quality, Safety & Clinical processes, it’s more important than ever that companies do their research when approaching RIM vendor selection and contracting. An overly generic request for proposal (RFP), or ‘safe’ shortlist made up of what everyone else seems to be using, is a risky starting point.

The Growing Expectations for RIM

Deploying a formal, optimised system or platform for regulatory information management is a given now for all Life Sciences companies, irrespective of their size and focus. Regulators expect this and, as data rather than static documents evolves to become the default means of submitting, exchanging and maintaining regulated product and process information, it follows that the systems for managing and keeping track of everything must be sophisticated and reliable.

In the 2020s, a strong, modern RIM platform should equip a company to:

  • Fulfil all of the differing and continuously evolving health authority requirements internationally.
  • Effortlessly and reliably track the status of products, their licences and current marketing authorisation applications.
  • Maintain a single, authoritative version of regulated product/process/licence truth that is    accessible centrally and locally by the people who need it.
  • Support future ambitions for process transformation, for instance beyond the scope of Regulatory Affairs – potentially encompassing adjacent functions such as Quality, Safety and Clinical operations – through integrated system capabilities and readily exchangeable data.

Although individual events such as a company merger or acquisition, or EU IDMP compliance, may trigger the decision to invest in a new RIM capability, it’s important not to progress this decision without considering the broader associated opportunity – e.g. to address internal data control challenges; transform internal visibility and decision[1]making; and ultimately re-imagine processes so that they are more efficient and support the business strategy more directly.

All these considerations should feed into the RIM selection process, which requires that all of the various business (as well as technical) stakeholders are consulted early on for feedback about their requirements and current process pain points. Thought should be given not only to what the company and its functional teams want and need to be able to do but also to scenarios they wish to avoid in the future. These might include: