As an information systems consultancy dedicated to successfully delivering lab-based information systems, we help our clients to overcome many different challenges. There are some important questions that we are frequently asked to evaluate.
In part one of this blog series, we’ll summarise the considerations to make when answering 3 common questions about lab informatics systems, all in the theme of ‘is a single system better than multiple similar systems?’
1. Should R&D labs use the same informatics systems as QC?
Here the context matters. If one were to generalise, R&D labs tend to be experiment-based, answering questions like ‘What ingredient changes in the product formulation will increase effectiveness and reduce environmental impact?’. On the other hand, QC labs are more focused on samples taken from production runs, and questions such as ‘Are the % composition of key ingredients within a production batch within specification?’
If we use the above generalisation and apply lab informatics thinking, in broad terms, ELNs are centred on recording experiments and therefore more suited to R&D. LIMS, being sample, test and results biased, are generally more suitable to QC labs.
However, it is not that simple. For example, perhaps one of the R&D labs provides analytical services to various teams executing R&D experiments – this type of ‘service’ lab is often better served by LIMS than ELNs.
The type of labs involved is not the only factor to consider. For example, CDS systems are generally applicable to both R&D and QC. The methods and use of the instruments may well vary across R&D and QC, but the instrument data systems can be exactly the same.
Finally, regulatory needs, specifically for QC can also be a driving factor in answering the question. We will consider this further in one of the following questions.
2. Should we implement a single global system or several more local systems?
When Scimcon first started nearly three decades ago, the focus within large multi-national companies was on implementing large, monolithic lab systems. This approach still has its place, particularly where the distributed labs are very close in terms of operational and analytical workflows.
Current thinking, however, looks to best support the diversity of lab workflows across global sites. While this should not mean a different system in every single lab, it should ensure some flexibility in selecting systems locally. This has several benefits, including a better informatics fit for each lab, and the increased local user buy-in gained by allowing flexibility.
However, against the background of the drive to increased data aggregation, data science and analytics, and AI/ML, this local approach can be counterproductive. It is therefore important to set standards and guardrails about how these systems are implemented, and how the data is structured and linked via reference data, so that consolidation into centralised reporting tools and data lakes is facilitated.
3. Should I have different systems for GxP and non-GxP work?
There is a well-used saying within regulatory-compliant organisations: ‘If a system contains just 1% of GxP data, then the whole system is required to be implemented, managed and maintained in a regulatory compliant manner.’
This statement leaves compliant organisations questioning:
Is it easier to run one regulatory compliant system, that contains both non-GxP and GXP data, and accepting that the non-GxP will also be subject to the associated GXP administrative overheads?
Or is it easier to have two systems, one GxP and the other non-GxP, the latter of which is subject to less rigid controls?
The first step to answering the question is to determine the delta between administering a GxP system, and administering a non GxP system. LIMS, ELN, SDMS, CDS and other lab informatics systems are often classified by labs as mission-critical. Most organisations wouldn’t countenance a lack of system administration rigour or releasing untested changes to mission-critical systems, so this delta may be lower than it first seems.
The next step is an open conversation with QA teams about the types of data being held, and the control systems that will be put in place. In the past, we have successfully taken a two-tier approach, where the administration procedures for non-GxP are simpler than those for GxP data in the same system. However, for this type of arrangement to be viable, a detailed risk assessment is required, and the ongoing management and control of the administration has to be very well executed.
Finally, before making the decision, it’s worth considering whether there are shared services or functions involved. For example, if the GxP and non-GxP work uses the same inventory management, it might be complex to get the inventory system interfacing and updating two systems simultaneously.
Summary
Hopefully, we have illustrated the importance of being clear about what your requirements are before answering these key questions about lab informatics systems. Each case is unique, and your decision will usually be based on a wide range of influencing factors. We help organisations to consider all of the options and roll out their chosen model.
Stay tuned for part 2 of this blog series, where we will look at the key question of how you can prepare your data for AI and machine learning.
The SmartLab Exchange Europe 2023, whichtook place from 22-23 February in Amsterdam, Netherlands, is one of the global meetings for lab informatics leaders. Scimcon continues its proud sponsorship of this event, as well as this month’s North American event in San Diego on 22-23 March, facilitating one-to-one meetings with a number of informatics customers from all major lab-centric sectors. The continued sponsorship of the event provides access to the community of senior R&D, Quality Assurance and Quality Control decision-makers from industry in both North America and Europe.
Feedback and voice of the Industry
Attending from Scimcon was co-founder and lead consultant, Geoff Parker, who took the opportunity to poll attendees and delegates of the attending organisations, to identify the current 2023 trends in the lab informatics industry. This includes R&D executives, Quality Assurance and Control leaders, and Regulatory specialists from organisations such as GSK, P&G, AstraZeneca, BioNTech, and more.
Summary of trends in lab informatics for the modern lab
In the informal poll of attendees at SmartLab Exchange, Scimcon has been able to identify key trends and themes that are important to the modern lab in 2023.
Of the total 73 delegates polled, 68 delegates – with budgets ranging between 500k to millions in GBP – volunteered which technologies they are interested in investing in within the coming 12 months.
Some of the key investment priorities included:
30.8% flagged digitalisation as a priority in 2023 (21 delegates)
20.6% noted automation as a priority investment area (14 delegates)
13% cited LIMS as 2023 priority (9 delegates)
When asked about additional investment priorities, 7 delegates stated that the following areas were also of interest this coming year:
Digitalisation, Agile process, AI
Automated Analytics/Analysis
Harmonisation
People/Talent
Risk assessment, based methodologies, toxicology, product expertise
Reducing QC Testing
Infrastructure
Attendees also ranked their interests and what topics they wanted to address at SmartLab. As illustrated, lab automation, and AI/ML in particular, are high priorities for lab leaders in 2023, with other high priority areas including data quality and integrity, instrument connectivity and IoT, and data integration.
Geoff summarises “As lab informatics consultants with a global customer base in leading lab centric organisations, it is important to us to check in frequently with influential decision-makers from the lab. SmartLab Exchange offers us a useful ability to poll the attendees and see trends that will impact the modern lab decision-maker, and will help us at Scimcon to hone the way we partner with our customers. The attendees we spoke to were split between R&D and QA/QC – with 43% in R&D, 24% in Quality, and 16% in both. We very much look forward to catching up with delegates at the US event in March, and it will be interesting to see how trends and priorities differ or align between the US and Europe.”
SmartLab Exchange is attended by invite-only decision-makers. The unique invite-only format of the event means that both sponsors, speakers and delegates can access a closed community that meets their individual needs.
Scimcon is proud to continue its sponsorship of the SmartLab Exchange Europe and US events in 2023, and the team is excited to connect with delegates at the US event on 22-23rd March 2023.
To learn more about how Scimcon supports science centric organisations with data solutions and lab digitalisation, or to organise a meeting at the US event, contact us today.
To catch up on the themes discussed in our EU panel discussion, you can read our blog here.
As a leader in a pharmaceutical or life sciences organisation, getting the most out of your team and resources is always a top priority. After making the decision to proceed with a critical investment in consulting services, there may even be more pressure to find the optimal use of these time-limited external resources. So, how can you make sure you are using these resources to their full potential? In this blog, our industry expert Micah Rimer will show you how.
During Micah’s 20 years’ working at big pharma & vaccines corporations, including Bayer, Chiron, Novartis and GSK, he has successfully deployed consultancy groups within lab informatics and clinical projects. Micah has worked with Scimcon to support his teams on high profile critical projects
Frame the problem – what does your implementation project need to achieve?
As with any business situation, it is important that there is a common goal that everyone is aligned around.
It is essential that you do not waste valuable time revisiting the same conversations. Ask yourself: “Is it obvious what problem we are trying to solve?” Often, issues can arise when people are arguing about implementing a solution, whilst losing sight of the challenge at hand.
Take the example of Remote Clinical Monitoring: You might decide that it would be beneficial to have your Clinical Research Associates (CRAs) track and monitor the progress of a clinical study without traveling to clinical sites. That sounds like it could be very promising, but what is the problem that needs to be solved?
Are you trying to reduce the travel budget?
Do you want to increase the number of studies your CRAs can cover?
Are you trying to get access to data more quickly so decisions can be taken faster?
Or do you want to increase the quality of the study?
Without clear goals on what you want to accomplish with Remote Clinical Monitoring, it will be difficult to declare an implementation a success. In addition, if you and your organisation do not know what you are trying to achieve with a particular technical solution, it will be impossible to give your informatics consultants a clear set of deliverables.
So, first things first, agree on the problem statement!
One of the first times I hired Scimcon to support me with an informatics project, I had recently joined a pharma company and found myself in the middle of conflicting department objectives, with what seemed to be no clear path out of the mess I had inherited. The organisation had purchased an expensive new software system that had already become a failed implementation. After spending a year continuously configuring and programming it, it was no closer to meeting the business needs than when the project had started. There were two loud criticisms to address on that point:
those who were upset that the problem had not been solved, that the business was still hampered by not having an overview of the laboratory data they needed; and
the second being the appearance that the department had spent money on software that was of no use.
This also highlighted a far wider range of issues, such as some people who felt their skills were not being properly utilised while problems went unsolved, and that the bioinformatics department might not have the right goals to begin with.
To solve this challenge, we sat down with Scimcon to identify all the different problems associated with the inherited project, and to clarify what we needed to do to turn it into a success. In taking time to review the situation and without too much effort, we were able to come up with four key areas to address:
Understand how bioinformatics/ IT priorities should map to the organisation’s priorities – before we spent any more time and money, what did the organisation actually need?
Solve the bioinformatics problem that the software had been purchased for (assuming that was indeed a verified need).
Determine how roles and work could be shifted and changed so that we were utilising the talents and the resources in the department.
If possible, put the purchased software to use!
With the help of Scimcon, we were able to define these problems and then focus on finding answers to each of the questions. In the end it turned out to be one of our most successful engagements together, award winning even. By just asking senior management what their biggest challenge was, we found their overriding priority was to have an overview of all the R&D projects going on. And while the new software was not particularly well suited for solving the bioinformatics problem that it had been acquired for, it could easily be used to map out the R&D process for portfolio tracking. Then, we turned our attention to the bioinformatics problem, which was easily solved by a bit of custom code from one of the bioinformatics programmers who felt that previously his skills were not being properly utilised.
Once we knew where we were, and where we wanted to get to, all we had to do was get there one challenge at a time.
Manage internal expectations – how will the informatics consultants work with your clincial/analytical teams?
Once you have identified and agreed on the problem that you want to solve, the next step is making sure the organisation is ready to work with your consultants. As with all relationships, business or otherwise, a crucial step is to make sure that everyone has the same expectations, and that all the relevant stakeholders are on the same page.
People have many different perspectives on why consultants are brought in.
Sometimes you need to bring an external voice to convince management of something most of the organisation already knows, as the conversation coming from an external party may be able to have more of an effect.
Sometimes you are looking for external skills and experience that you do not have internally that are needed to achieve a specific goal. Maybe you are trying to implement some new workflow or technology, or you are moving into a new area of responsibility with which you are not familiar.
Other times you may have the skills internally, but not the resource availability. You and your key people are all tied up in the daily operations and have no time to change your systems and processes into a more efficient way of working.
As there can be so many different roles and perspectives on the use of consultants, you need to make sure that you address all the different stakeholder perspectives. It is important to establish a positive situation, as you want the consultants to be able to work with your teams without unnecessary tension.
When I was just starting out with my first LIMS implementation (Laboratory Information Management System), I remember being impressed that you could hire someone who had the specific experience and expertise to guide you on something they had done before but that was new to you. I wondered, “why was that not done all the time? Why do so many implementation projects fail when you can bring people in who had solved that particular problem before?” When I asked Russell Hall, a consultant at Scimcon for us on that first project, he said that not everyone is comfortable admitting they need help. As my career has progressed, I have come to value that feedback more and more. There are many people who are highly competent and effective in their jobs, but are not comfortable with the appearance that they are not sufficient on their own. It is always important to manage for those situations, rather than assuming that everyone will welcome external help.
Lastly, it is also critical to manage expectations, regarding the use of consultants. Your boss may need to defend the budget, or be prepared to stand behind recommendations or conclusions that are delivered from people outside of the organisation. It should also be considered that management might not readily accept something that might seem obvious to employees working at a different level. By liaising with senior leaders from the outset, you can make sure both parties are aligned how the consultants will interact with people in the company, and what their role will be. This is important both to achieve what you want internally and also to make sure the consultants have a proper expectation of how their efforts will be utilised.
Communicate and adjust – how is your information managed between your team and consultants?
While it can be very tempting to feel that you can leave the majority of the project to the experts, the reality is things rarely go as smoothly as planned. As the life science business and information management have advanced over the last few decades, the amount of complexity and details has grown tremendously. It is more and more difficult for a single person to maintain an overview of all the relevant facts. The only way to be successful is to communicate and make sure that the right people have the right information at the right time. Your consultants are no different.
Many organisations have challenges in terms of taking decisions and communicating them effectively. For your consultants who do not typically have all the same access and networks in the organisation that internal staff do, it is imperative that you make sure they are kept up to date. You want to avoid them spending valuable time on focusing on areas and deliverables that have shifted to being less important. Finding ways to keep consultants informed on all the latest developments is absolutely necessary for them to be able to deliver successfully. Figure out what makes sense by considering the organisation culture and the consulting engagement setup. Whether it is by use of frequent check-ins or online collaboration, be prepared to put in additional efforts to make sure that the information gets to where it needs to go.
As well as good communication, organisations have to be able to adjust as needed. Occasionally everything does work out according to plan, but that is more the exception than the rule when it comes to complex life science informatics projects. While timelines and commitments are critical, it is important to view any project as a collaboration. There will be unexpected software issues. There will be unplanned organisational changes and problems. People get sick, life happens. By having open and continuous dialogue, you can be best prepared to make the adjustments needed to find solutions together to unexpected problems.
Ensuring success in your informatics projects
Consultants can be hugely valuable to you and your organisation.
But you have to setup the right conditions for everything to work out well.
Know what the problem you are trying to solve is, and make sure you have as much alignment around the problem statement as possible.
Make sure the organisation is ready for the collaboration by ensuring that your team and management know what to expect out of the engagement, and that your consultants similarly know the scope and what their mission is.
Lastly, you need to keep in constant communication and make sure that you are ready to work together to adjust to the inevitable bumps that will come up on the road.
Working together, you can get to where you need to go.
If you’re interested in working with Scimcon on your upcoming informatics project, contact us today for a no-commitment chat about how we can help you succeed.
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