Effective vendor selection and contracting is critical to support regulatory information management capabilities that increasingly lie at the heart of quality and clinical processes. Romuald Braun, Managing Partner at MAIN5, provides some practical pointers.
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.
Regulatory information management – data default
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-making; and ultimately re-imagine processes so that they are more efficient and support the business strategy more directly.
All of 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 future. These might include incurring delays/business interruption and new cost as new features and capabilities have to be added to the system later, issues with system or data incompatibility if the company later tries to improve the connection and information flow with other departments or part of the global organisation, and issues arising from a change to the software vendor’s circumstances.
Holistic approach to vendor selection
A structured, holistic approach to vendor selection is the best way to ensure that nothing is left to chance in the choice of a new system – from its long-term strategic fit, and lasting deliverability for all target users, to the fulfilment of procurement requirements around cost/value for money, sustainability and so on.
Taking a structured approach (e.g. applying an agreed vendor selection methodology) will make it possible to score each option/each long-listed vendor across the full range of criteria, including user requirements and priorities; the strategic/wider digital transformation roadmap and technical/IT considerations, such as system architecture specifications.
While no single solution will tick every box, following this formalised vendor selection approach will ensure that each RIM proposition and supplier is considered from every angle. This means that any trade-offs (e.g. in specific user features that may be sacrificed for a more holistic platform serving multiple departments) can be duly considered, communicated properly and agreed pragmatically – an essential pillar of effective change management.
Starting with a standardised approach (to establishing user requirements, for instance) is a great way to get teams thinking about what is most important. That could be across a series of common or desired use cases. In a Regulatory context, these might include variations management in marketing authorisation; IDMP-specific processes; and investigation of new drugs in key target markets.
Thinking through each scenario will help focus teams on what they need from a new system – before they make their choice.
There’s no substitute for seeing a new system in action. Ideally this should be via a bespoke demo applied to routine use cases and familiar scenarios – better still, using the company’s own data (e.g. via a demo ‘sandbox’ environment).
Vendor scoring for future needs
It is in the vendor’s interest for target users to understand the system’s potential in their own setting and routine context. Requesting and securing this will enable a more confident and better-informed decision. If the demo can also reflect processes as they might evolve in the future (e.g. as Regulatory is blended more seamlessly with Quality and Safety, if this is a strategic aim), so much the better.
Investing the time in a proper needs assessment is a powerful way to get everyone on board and manage expectations, which in turn will cement user acceptance and ease change management.
Using a formal methodology in vendor scoring and selection can help in the negotiation and contracting process too, by drawing attention to what is essential versus less important. It’s also a means of ensuring that additional considerations (e.g. data preparations/migration, and issue resolution, and potential future data transition requirements) are factored into the contract and pricing.
Remember that data-related work is rarely a one-time event, so it will be important to specify, scope and assign ongoing processes – and relative accountability – around data (data governance).
Indeed, the success of any project requires that internal teams also allocate sufficient time and resources to its effective delivery. A good contract should protect the interest of both parties.
A good pain-saving tip is to let business-savvy technical enthusiasts within the company play around with capabilities to see what they can do, something that is easily provided for today via the cloud. This active user involvement is much more illuminating than watching a pre-set vendor demo, and will drive home an understanding of what’s really important when specifying and choosing a new platform.
During this process, users will be able to assess how easy it would be to work with potential suppliers on a day-to-day basis. Every company has its own culture, set of beliefs, and way of working, and a good match will help ensure a harmonious relationship and optimum outcome.
Time spent at this stage, identifying specific requirements and thinking ahead to future evolution, is well spent in developing regulatory information management capabilities that will support effective quality and clinical processes as well as ticking all the regulatory boxes.
About the author
Romuald Braun is Managing Partner at MAIN5, a European consulting firm specialising in organisational and digitally enabled change in Life Sciences. MAIN5’s consultants are deeply experienced in vetting and implementing RIM and other critical Life Sciences platforms and systems for biopharma and medical device companies around the world. Its BPMN 2.0-based methodology for vendor selection fulfils 85-95% of most companies’ requirements when assessing a RIM or other platform vendor. MAIN5 also provides a range of services from supplier contract development to change management.
