All transformation ambitions start with better data – but how will this materialise?
The output of any IT system relies entirely on the quality of data entered into it. As day-to-day business practices and processes become more ‘data driven’, it follows that more focus will be needed on improving inbound data quality, integrity - and its upkeep.
Yet this won’t happen unless companies cultivate the right organisational culture and behaviour, from the top down and bottom up.
After so much focus across the life sciences industry on system enhancements and adoption of standards to ensure compliance with the latest regulatory requirements, many companies have become somewhat side-tracked by the technicalities. When focusing on the right technology infrastructure, and streamlining internal processes, it becomes easy to lose track of the data itself - who will own it, who will be responsible for its quality and value, and how will this be monitored.
So, it’s excellent timing that Generis is organising a new cross-industry debate on this important theme (details below).
Set expectations – and reward progress
Ensuring optimal data quality isn’t just about the processes and tools involved. It’s also about assigned roles and responsibilities; appropriate KPIs and metrics; use of motivation and reward systems; and good sponsorship and advocacy – which includes setting the expectation, right from the top, that rich and accurate data matters, and is everyone’s responsibility.
Yes, there are external, regulatory drivers for all of this, which have made maintaining comprehensive, high-quality data, that’s readily available for scrutiny, a condition of doing business. But, there are other compelling reasons for companies to get to grips with their data. Teams inputting information must be aware of the importance of their role, so that they take pride in their attention to detail and in creating a bank of reliable, easily-downloadable knowledge that can support all manner of use cases.
It’s for this reason that I tend to advise against creating many new roles or bringing in external resources to look after data input and data maintenance. It can be far more effective to give existing teams more control over their own data – and to allow them to see first-hand the benefits of having more - and better - data readily at hand for review and decision making.
When data input becomes someone else’s job, that sense of purpose and value can be lost. It inevitably also creates the need for new rounds and additional verification steps – not to mention the cost of additional software licences for those extra system users. Typically, it can be more effective to re-orient an existing team member’s role – away from manual submission work, for instance, towards preparing / checking data for entry via the authority’s portal.
Rather than leaving designated team members to simply absorb their new duties, deliberately seeking out and celebrating success can make a world of difference to those involved. One way is to highlight data-related improvements through KPIs/metrics showing relative transformations; another could be to demonstrate what a difference good data is making at a practical level and to overall compliancy.
Something as simple as teams being able to see their data on dashboards, pulled into status or management presentations can be hugely motivational; for example, recognition of the number of submissions enabled by readily available and complete supporting data (avoiding the need for last minute verification). An accelerated submission for a new indication could have a significant impact both for the business, and for patients.
Helping data owners to see the outcomes of their diligence will shine a light on ‘why’ they are being asked to be so meticulous in their data capture and recording.
Why re-tread old ground?
For any organisation reappraising its data credentials, it is a great time to think outside the box and be creative about the organisational set-up and people’s roles and responsibilities. Regulations such as the EU Clinical Trial Regulation forthcoming EU IDMP, do add complexity and require a reassessment of organisational operations. However, there will only ever be a limited combination of key processes along the life sciences value chain.
People’s roles in managing data, and the organisational structure around that, are the only real variables. So, the opportunity here is to up-skill the organisation in order to optimise data governance and data quality. Why not make the most of this?
Preeya Beczek, Director of Beczek.COM Ltd, is an independent regulatory affairs expert and change agent, with extensive experience gained over 25 years. Her work extends strategically and operationally across the full development and post-marketing value chain, for pharmaceutical, biopharmaceutical, and biotechnology companies, contract research organisations, as well as the chemicals industry. She also collaborates with Gens & Associates on a variety of regulatory topics including co-creating the Data Quality Sustainability / Governance Operating Model.
Register for our Big Debate Live Panel Discussion ‘The future will be data driven by who will steer it?’ on 1st December featuring Preeya Beczek, Dr. Melanie Ruppel, BioNTech, Vada Perkins, Bayer, Frits Stulp, Iperion, moderated by Max Kelleher, COO, Generis. Register here.