Deloitte’s Patrick Middag and Dennie van de Voort provide some practical steps to creating and entrenching effective data governance practices which in turn can help elevate the quality and value of regulated pharma data – not just for the immediate use case, but also for other critical applications beyond the regulatory function.
Key insights:
- Maintaining data quality and consistency holds the key to critical pharma production and regulatory processes.
- Establishing a data governance structure, including appointing a Data Governance lead, an interaction model and company awareness would help provide that clarity and direction.
- There is the potential for mass-scale market disruption by the Big Data players, which have all the skills and resources to challenge the Life Sciences & Healthcare industry head on with their strategic use of data and analytics.
The impact of any digital process transformation program relies heavily on the quality and reliability of the data that feeds into those processes. If that data is patchy, inconsistent, out of date, or incorrect, risks will be magnified each time someone re-uses that data. Operationally, inconsistent information exchanged with the regulators will lead to non-compliance risks, risks of poor quality and ultimately patient safety and public health risks. More strategically, it will limit companies’ ability to perform useful data analytics and to increase their business efficiency, reducing the time to market and patients.
All kinds of critical processes in life sciences now require a dependable flow of agreed data (in addition to compiled documents), and major international regulators including the EMA and FDA have set out firm plans and frameworks through which this must be captured and exchanged. The need to adequately record and maintain data elements (e.g. product ingredients, formulation, packaging, clinical particulars, manufacturers) from different functions, requires clear alignment and consistency across the enterprise and its different product touchpoints. Furthermore, companies must keep up with ever-changing data standards.
Tackling these challenges requires effective data governance practices. However, as we have seen with clients, this is one of the most difficult and complex topics for organisations to address.
Data is the new oil
A sobering point here is the potential for mass-scale market disruption by the Big Data players, which have all the skills and resources to challenge the Life Sciences & Healthcare industry head on with their strategic use of data and analytics. For example, Google and Amazon have already started to make strides into the industry. It would not be much of a leap for these companies to enter the generics world, attract the right scientific talent and branch out into research around innovative therapies.
This is a real wake-up call to any company currently not taking the strategic role of data as an asset seriously. So where should companies start in embedding the right mindset and everyday working practices?
The strategic role of data
Most pharma organisations are already aware of the role data will play in their operational and strategic future, but in the majority of cases there is a gap between that appreciation and what it means for managers, teams, and individuals - and for day-to-day behaviour. Although there may be some level of understanding that ‘good data’ is everyone’s responsibility, a lack of clarity around data ownership, and cross-company data handling and use, is obscuring the way forward.
The first element that’s needed, then, is a clear overarching data management strategy, with cross-functional buy-in and active sponsorship from the top of the organisation, typically starting with the CDO, CIO or CDTO. Without this, any progress with data governance and data quality will be confined to the given team or department. This will limit the benefits and undermine the potential return on investment – especially if other teams go on to duplicate or dilute the good data’s value, e.g. by editing it in a way that conflicts with the correct source information, or does not adhere to the defined data standards.
Although regulatory teams may seem the obvious point of call for good, correct data about a product across its lifecycle, once companies start to trace that data back to its source they begin to realise that the reality is far more fragmented. The real originators of that data are likely to be CMC teams or clinical research scientists, who often don’t realise that they hold a responsibility toward regulated product information and who are often also unaware of the importance of their data in other processes and systems elsewhere in the company.
So senior stakeholders higher up the organisation will need to sponsor an organisation-wide data governance strategy, designed to foster consistent use of robust, reusable, standards-based data.
Communicating the value of data
With the vision in place, companies will need to define roles and responsibilities linked to data’s quality. They must also communicate data’s value to the company, create clear rules, and measure progress of data governance.
Up to now, if an issue emerges with data quality, business functions typically look no further than one or two steps forward or one or two steps back to resolve the issue. Their focus is often on the immediate use case, on how they can fix the issue to satisfy local needs or compliance requirements. There is no deeper investigation to ensure that information is correct at the source, or how any issues with the data have arisen – so that these can be avoided in future. Most of the time, such shortcuts are taken because there is no time, no budget, or no immediate business driver.
The lack of clarity around data ownership, data consumers or data business purpose, are typical causes of all this. Establishing a data governance structure, including appointing a Data Governance lead, data owners and data stewards, an interaction model and company awareness through change management efforts, will help provide that clarity and direction.
Hand in hand with establishing data governance roles and responsibilities, senior stakeholders need to communicate the evolving role and value of data, so that the entire organisation begins to see and treat data as an asset to be harnessed across a range of contexts. In large organisations, creating this new mindset requires a proper change management program.
Defining and clearly documenting the company’s preferred data standards is another important activity. Simply copying and pasting, let’s say ISO IDMP specifications into new procedures, could do more harm than good: guidance needs to be practical, actionable and clear, so that users can absorb the new rules at a glance.
Technology to support good management
Inevitably, there will be technology considerations as part of this journey - particularly given the need for a smoother flow of consistent, compliant data between departments and across use cases. This will require appropriate data and technology architecture and integration skills.
A smarter and more involved system capability, which will be necessary for large international pharma organisations, should for example automatically flag any gaps in data ownership or sources if someone leaves or moves on. Such capability also serves as an impact assessment tool whenever changes occur to data, ensuring that the details are reflected elsewhere.
Ultimately, though, good data governance should remain a company-wide management practice, which starts with the right strategy and mindset. Improvements to data quality and reduction of data quality issues should be celebrated, perhaps reported in a monthly data governance newsletter, for instance.
Enterprise data governance is not a one-off big bang project. Incremental steps will create a foundation on which to build data quality that underpins pharma business success and great outcomes for patients.