The PV automation misnomer - Are UK & US pharma companies still missing an opportunity? - Arriello
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The PV automation misnomer. Are UK & US pharma companies still missing an opportunity? An Arriello survey, October 2021. © Copyright Arriello Ireland Limited 2021. Please credit Arriello in all content citations, whether print or online.
Foreword by Dr. John Price.
To get what you want, you first have to know what that is –
and that’s particularly true of PV automation.
There is a belief that it is not possible to This year’s Arriello PV automation survey
achieve all three desirable outcomes when sought to explore drivers and progress
transforming processes – i.e. that they around associated technology adoption and
become faster, better and cheaper. has come up with some interesting findings.
Rather, companies should settle on two It confirms that many companies are
of these priorities, and be prepared to indeed reviewing and progressing
sacrifice the third to achieve these. their plans for process automation,
and – interestingly – that quality rather
In the first decade of the 21st century, as than cost is now the driving force.
workloads soared, companies across
the pharmaceutical industry embarked Certainly there is no point processing
on initiatives to reduce the cost of PV data at low cost if case management
pharmacovigilance (PV) operations. can’t be fully trusted. This simply creates
more work for PV teams in fixing the gaps.
They did this first by outsourcing, and
then by offshoring their activities. Fear of human replacement is notably
very high, rising from seventh to second
Ten or more years later, Pharma is place in this year’s study as an impediment
finding that the cost savings achieved to tech adoption among PV staff.
have been at the expense of quality.
This suggests the messages that automation
As a result, some are seeking to rebuild can relieve an already over-stressed workforce,
internal PV capabilities – despite the higher and free up skilled professionals to do
cost, not to mention a talent shortage. higher value/more rewarding analysis work,
are not yet fully appreciated.
An alternative solution is to harness
technology, specifically AI and
process automation solutions.
We need automation not because
there are too many people in PV,
but because there aren’t enough! >>
2
>> This year’s question In Drug Safety, a growing desire among
About John...
about perceived barriers clinical operations teams to leverage
to automation found that the main electronic data capture for serious adverse
obstacle remains systems validation, event (SAE) management presents problems
but it is now cited more frequently different to those facing post-marketing PV.
than in 2020 by PV professionals.
Anecdotally, and from personal experience,
It is going to be important to address it appears it may be more effective to develop
this obstacle. Repurposing some staff new solutions tailored to their needs.
as system managers should provide the
resource needed to confirm an automated Despite the challenges reported, the number
system is processing cases correctly. who already use automated solutions is
intriguingly high. Widespread technical
There were some interesting differences solutions with limited overall impact may
about the validation barrier between those be being counted as “automation”.
in PV vs Drug Safety, with those in Drug
Safety rating ease of use and cost as However few may actually be automating John Price is an executive physician
much more tangible considerations. case processing end-to-end, which with deep experience gained from over
is where real benefits can come. 25 years working across the breadth
This may reflect current practices in clinical of regulatory affairs and
study teams, which tend to be more labor It is perhaps in the survey’s open responses, pharmacovigilance worldwide.
intensive yet involve managing about what companies would like to see
lower case volumes. more of, that we get to the real nub of where He has created and led high-functioning
teams are looking for new help and value global departments for pharmacovigilance,
The survey suggests beyond PV departments, – particularly around accessibility, ease of regulatory and clinical operations, medical
technology solutions may be lagging. use, and the ability to do more with data. writing and drug development, and held
senior roles in the UK Medicines Control
Agency (now MHRA), Pfizer, J&J, Alexion
Pharmaceuticals, and in academia.
Based in the US, John is an advisor
to Arriello.
3
The PV automation misnomer.
Are life sciences companies still missing opportunities to lighten safety reporting workloads?
Across all facets of the industry, on both sides of the Atlantic, and between Pharmacovigilance, Drug Safety
and Product Safety teams, there is evidence that teams are still not benefiting fully from today’s process
automation potential, to enhance delivery of the important work they do.
Typically, companies have implemented automation in fairly limited and focused ways that make only
a small impact on overall PV operations (an example being auto-listedness).
Similarities... and differences.
In mid-2020, Arriello commissioned a first But this time our research dug deeper,
milestone survey into the pharmaceutical seeking to distil what companies meant
industry’s planned and developing use by automation, and to determine the fuller
of automation solutions to ease the opportunities that might be going untapped.
delivery, and improve the quality, of
adverse event reporting as part of their Again, we targeted a similar research
pharmacovigilance (PV) safety obligations. base – 200 professionals at manager level
and above working in the PV, Drug Safety
Conducted independently by Censuswide, or Product Safety departments of
the poll of 200 respondents – in senior pharmaceutical companies, split evenly
roles spanning PV, Drug Safety and Product between the UK and the US.
Safety departments, on both sides of the
Atlantic – suggested that a surprisingly high The online research took place in late July/
percentage of organizations were already early August 2021, as many companies
progressing on their journeys to automation. were evaluating an imminent return
to the workplace and to more familiar
A year on, a follow-up poll reflected similar modes of operating as COVID-related
claims, even despite the substantial restrictions started to be eased.
disruption of the COVID-19 pandemic.
4
What a difference a year makes – or has it?
Unsurprisingly, the pandemic has dominated (RPA), standalone PV automation, or PV Often, however, when companies talk
decision-making over the last year and automation as part of something bigger, up about automation, they are not referring to
in many cases this has been reflected to two thirds of companies claimed to have end-to-end processing (case collection,
in setbacks to automation initiatives. solutions “already in place” or were “likely” database work, triage, reporting) but rather
to do so in the next 12 months – when asked leveraging IT to support elements of case
Although the majority of the respondents about plans to implement PV automation processing (e.g. auto-scheduling reports
in 2021 were as upbeat as those taking on a larger scale. Meanwhile no one for submission).
part in the research last year, in suggesting suggested their organization was
they were already making strong progress not considering automation as a This is a shame, given the broader process
with process automation in Safety and PV solution to rising PV workloads. automation opportunities now – for instance
PV, many had seen plans put on hold as to simplify the work of reporters (HCPs,
other priorities came to the fore, and as The highest levels of current adoption were patients), enabling them to make their reports
office-based activity suffered disruption. found in PV departments, where more than directly into the PV database, circumventing
half of respondents claimed some level the effort of data entry. This is similar
Intentions remain strong, however. Whether of PV automation was already in place conceptually to electronic data capture
categorized as robotic process automation as part of a wider technology set-up. (EDC) in common use in clinical trials.
Which of the following, if any, Pharmacovigilance (PV) Automation technology or
Question:
methodology have you adopted already or plan to adopt?
Robotic Process Automation Stand-alone pharmacovigilance Pharmacovigilance automation
(RPA) automation solution delivered as part of a larger solution
39.5% Already in place 41.5% Already in place 49.5% Already in place
44.0% Under evaluation 42.5% Under evaluation 36.0% Under evaluation
15.0% Likely in the next 15.0% Likely in the next 14.5% Likely in the next
12 months 12 months 12 months
1.5% Not under consideration 1.0% Not under consideration 0.0% Not under consideration
5
COVID-related delays to automation initiatives.
Although more than a third UK organizations were much less often In Product Safety, concerned especially
impacted than their US counterparts. with managing product defects in
of all respondents said their a quality assurance context, delayed
companies were currently Encouragingly, only two per cent said decision-making was more of an issue.
evaluating automated solutions, that the pandemic had curtailed
automation projects completely. For dedicated PV functions,
progress may have stalled during which could be processing vast volumes
the pandemic as many said they Where COVID had played a part in temporarily of AE reports linked to many thousands
have solutions in place in 2021 side-lining projects, the most common reasons of marketed products, remote
listed were financial uncertainty (cited by working had proved a more significant
as in 2020, despite in 2020, more than half of relevant respondents), barrier to automation progress.
around 40% expecting delayed decision-making (mentioned by
to introduce automation 46 per cent), reliance on offshore services PV and Drug Safety personnel teams were
(44 per cent), talent challenges (42 per cent), most likely to have been affected by offshoring
in the next 12 months. and remote working (38 per cent). issues, which we can attribute at least in part
to the devastating effect the pandemic
Asked specifically about the impact of Those working in Drug Safety were has had on India, a major hub for IT support.
COVID, just under a third (30 per cent) said more likely to be affected by financial
initiatives had been delayed by up to six uncertainty and talent shortages, reflecting
months; while a further third (31 per cent) the correlation with these roles and the
said timelines were now 6–12 months out. biotechs/startups taking part in the study.
6To what extent has COVID-19 affected progress with
Question:
PV automation in your organization?
No impact
32.0% Delayed it by up to 6 months
Delayed it by over 6 months up to a year
2.0%
30.0%
Delayed it by over a year or longer
5.5%
Completely stalled progress
30.5%
What would you say were the causes of that impact/delay
Question:
due to COVID-19? (Tick all that apply.)
52.2% Financial uncertainties
45.6% Delayed decision making
44.1% Reliance on offshoring
41.9% Slow up in recruitment/talent acquisition
37.5% Remote working
7Definitions of automation.
In last year’s survey, we identified diverse To drill a bit deeper, in this year’s survey But still, the figures are perplexing around
interpretations of ‘automation’ in companies’ we asked more specifically about the AE reporting. This remains a high-pressure
responses. It appeared that the high areas of PV/Safety in which companies activity for pharma organizations, because
proportions of those claiming to have planned to invest in smart (AI-enabled) of the high volumes of incoming content,
implemented PV automation solutions or robotic process automation (RPA). the diversity of capture points and formats,
were most likely to be inputting data into and the very tight timelines for reporting
IT systems, without really benefiting from Overall, clinical documentation management serious real-world safety events.
labor reduction and resource redeployment. was the area most likely to have been
automated already, followed by product Some 42 per cent of all respondents,
Our own observations tell us that many quality compliance information handling rising to 48 per cent in the UK alone,
organizations employ basic electronic data and medical information management, claimed to have automated AE reporting
capture in clinical development, electronically then standard document compilation solutions already in operation.
report safety cases to agencies; generate (forms, PSMF, aggregate reports, etc.).
auto-narratives; program tabulations; and Yet our experience tells us that the solutions
listings for aggregate reports and so on. For planned investment over the next currently in play at most organizations or
12 months, literature screening and their outsourced service partners are not
This functionality is often included in the auto-narrative generation were the most true timesaving or quality-enhancing tools;
platforms provided by safety vendors and, popular areas of focus, cited by more than rather they are software systems into which
in the main, these productivity aids bring a fifth of respondents across the board. professionals manually input their findings.
limited new value to the PV function.
Beyond that timeframe, smarter As we ventured last year, this suggests
Last year we wondered whether our regulatory intelligence management and that companies are still not realizing
initial survey findings might have masked automated document compilation were the fuller potential of automation.
relative immaturity in adverse event (AE) the main areas under evaluation.
case intake automation, for instance – With this in mind, we asked about
a category of solution that can make companies’ drivers for investing
a substantial difference to the effort of in PV automation.
processing intense PV workloads.
8Question: In which areas of PV do you plan to introduce automation or AI?
Adverse Event Reporting Literature Screening Regulatory Intelligence
42.0% Already in place 40.0% Already in place 40.0% Already in place
38.0% Under evaluation 35.5% Under evaluation 40.5% Under evaluation
19.0% Likely in the next 23.0% Likely in the next 17.5% Likely in the next
12 months 12 months 12 months
1.0% Not under consideration 1.5% Not under consideration 2.0% Not under consideration
Document Compilation (standard forms, Medical Information Clinical Documentation
PSMF, aggregate reports etc.)
43.0% Already in place 44.5% Already in place 48.5% Already in place
40.0% Under evaluation 39.0% Under evaluation 30.5% Under evaluation
16.0% Likely in the next 16.0% Likely in the next 20.0% Likely in the next
12 months 12 months 12 months
1.0% Not under consideration 0.5% Not under consideration 1.0% Not under consideration
Auto Narrative Generation Product Quality Compliance Information Other
39.0% Already in place 45.5% Already in place 25.0% Already in place
36.5% Under evaluation 38.0% Under evaluation 37.5% Under evaluation
22.5% Likely in the next 16.5% Likely in the next 21.0% Likely in the next
12 months 12 months 12 months
2.0% Not under consideration 0.0% Not under consideration 16.5% Not under consideration
9Automation drivers.
On the basis that achieving equal improvements For small biotechs, performing Phase I and
across quality, speed of delivery and cost is Phase II trials of cutting-edge science applied
rarely possible, we asked respondents to indicate to medicine – such as gene and cell therapies
the two more dominant drivers of the three. – the need to understand what is happening
with already very sick patients, especially
Across the research base these emerged when there are many moving parts involved
as quality (cited by 71 per cent) and speed (Drug Safety teams, clinical development
(mentioned by 67 per cent). Quality was teams and CROs) – is paramount, so
deemed even more of an issue for those accelerating the speed of information/report
with a PV-specific remit, suggesting this is processing is clearly going to be a priority.
an area they are trying hardest to improve.
For Product Safety teams, and for
Those working in Drug Safety, where clinical organizations in the US more than those
studies are the main source of Safety data in the UK, cost was the higher priority.
capture/reporting activity, were considerably
more likely to prioritize speed of delivery. Typically, Product Safety teams – Automation has
usually associated with medical
This makes sense given the huge time devices and combination products provided us with
pressures around submitting complete reports – are concerned with processing real-time data, which
to the authorities – especially between days 7 high volumes of information about
and 15 in the US where teams must develop defects, such as particulates in vials has saved lot of time
the full context around their findings. or faulty syringes, activity which and improved results.
tends to be more usually resource
intensive than inherently urgent.
What are the two most 71.0% Quality
Question:
important drivers for
66.5% Speed
PV automation in your
organization? 62.5% Cost
10Anticipated benefits of PV automation.
Quality-wise, improved data quality is the to 38 per cent for Drug Safety teams, who also
chief objective of automation initiatives, cited prioritized the ability to report more promptly.
by 35 per cent of respondents – rising to
40 per cent among those in Drug Safety roles. In terms of cost reduction benefits PV automation has
linked to automation, Product Safety
For Product Safety teams, by far the bigger teams were most likely to be seeking the greatest value
preoccupation is improved compliance – cited reduced infrastructure costs, and least where we need
by 44 per cent of this cohort as the main goal likely to be targeting labor replacement.
of quality improvements, compared to an
to track data and
average of 34 per cent across all respondents. US respondents were also slightly ensure its accuracy.
more inclined to be looking to reduce
Operational improvements were also a priority, infrastructure related costs.
though less so for Product Safety teams.
UK respondents were more inclined
For speed-related improvements, accelerated towards more cost-effective scalability
processing was the main benefit sought, cited by (a priority for 37 per cent of UK respondents,
34 per cent of all respondents – rising compared with 29 per cent of those in the US).
Which of the following, best reflects the benefits for automation in your
Question:
organization based on Quality, Cost and Speed?
Quality Benefits Cost Benefits Speed Benefits
34.5% Improved Data
Quality 37.0% Reduced 33.5% Faster
34.0% Improved infrastructure processing
Compliance 33.0% Scalability 32.5% Greater focus
31.0% Operational 27.5% Reduced on safety
improvements manpower 32.0% Faster reporting
0.5% None of the above 2.5% None of the above 2.0% None of the above
11Solution suitability.
Probing more closely, we asked respondents to Of the remaining responses, the following Providing reliable decision support:
rate currently available PV automation systems themes were most pronounced when e.g. for accurate evaluation of costs;
for their ability to meet their companies’ needs. survey participants were asked how improved Regulatory intelligence.
existing solutions could be improved Use of AI to both improve quality and
Drug Safety teams felt the least well to better meet their needs: reduce costs.
catered for overall, with 16 per cent giving
Improved quality and accuracy Use of natural language processing
a neutral score of 5 out of 10, and the highest
of information at the time of data and machine learning to further
proportion (29 per cent) scoring only a 7.
compilation. improve the automation.
Product Safety teams were significantly Providing a more structured way of Improved productivity and efficiency.
more satisfied (56 per cent scoring 8–10), data collection to aid analysis. More affordable solutions to match
and more typically UK respondents had Improved data management. budgets under pressure.
a more positive outlook compared to their Reducing the time and effort expended
US peers (36 per cent vs 20 per cent stretching on data entry and manual processes. The implication is that
to a satisfaction score of 8 out of 10). Improved usability. automation solutions clearly
At this point, the survey provided for
Improved speed of processing.
hold perceived value, but that
open responses to tease out some of the Support for a single drug safety
database.
companies need the scope
reasons PV and Safety teams felt current
solutions might fall short of their needs. Use of real-time data, saving time and to increase and for the benefits
improving results. to be more visible and easier
Tellingly, 56 per cent answered “I don’t Support for fool-proof signal to access.
know,” rising to 60 per cent of specifically management and a strong safety
UK-based respondents and 74 per strategy.
cent of those in Drug Safety roles.
12PV automation makes quality assurance easy.
It’s just a matter of overcoming validation
requirements and providing ease of access.
Usability issues and fear of the unknown are
what hold people back, which is a shame
given that integrating functional events
through PV gives awesome results.
How well do you think currently available PV automation systems match your
Question:
needs? (Scale from 1 to 10, with 1 being not at all and 10 being fully.)
Not at all Fully
1 2 3 4 5 6 7 8 9 10
0.0% 0.0% 1.5% 4.0% 11.0% 13.5% 20.5% 28.0% 7.5% 14.0%
13Barriers to progress: validation; ease of adoption & fear for jobs.
In last year’s survey, the three top perceived Fear of human replacement was a particular Product Safety teams were by far the most
barriers to PV automation were IT related. issue for PV teams (cited by 42 per cent likely to cite this as a barrier to automation.
of this cohort, in contrast to 22 per cent
This time, although the age-old challenge of those working in Product Safety. This further supports our suspicions from
of system validation remained a key last year about differing perceptions of what
concern, cited by the same proportion of This suggests a misconception that job losses constitutes “automation”; that the technology
the research base (41 per cent) in 2021 as are inevitable when an automated solution and service provider industry must work harder
in 2020, familiarity, ease of use and cost is implemented, when in reality automation to educate the market on emerging options.
were the next most significant barriers to paves the way to retain talent which is
embracing new automation opportunities. currently considerably over-stretched. That system validation still presents as
such a high barrier to process innovation/
Cost was the steepest hurdle for Drug Matters of IT infrastructure were most likely improvement is disappointing.
Safety teams (cited by 46 per cent, to register as an issue for Product Safety
compared to an average of 37 per cent teams, and for respondents in the US. PV professionals know how to validate a system,
across all respondents), while perceived understand how to do it, and have the resources
issues of usability featured least acutely A perceived lack of available solutions to be able to monitor and confirm the machine
for PV teams (many of which consider was cited as a barrier to adoption by is doing what it is supposed to do, with the
themselves to be fairly automated already). 43 per cent of UK survey participants, quality and consistency required. And in the
compared to 27 per cent in the US. meantime, work on more value-based tasks.
What do you see as the main barriers to the adoption of PV automation in your
Question:
organization? (Tick up to three.)
41.0% Systems validation 36.5% IT Infrastructure
38.5% Lack of familiarity with the technology 35.0% Lack of available solutions
37.0% Cost 35.0% Fear of human replacement
37.0% Ease of use 0.5% Not applicable – there are
no main barriers
14Conclusion.
That there remains much confusion around On a more positive note, companies
the real potential of true PV automation are clearly prioritizing quality and
solutions is both a challenge and an processing speed above cost now when
opportunity – for life sciences companies, exploring new automation options.
and for the technology and service providers
striving to help them achieve more with less. It is likely that the pandemic has shone
a light on the fragility of offshore outsourcing
While 2020–21 has been an exceptional arrangements, which have emphasized
period for all kinds of businesses, the lower costs for case processing – often at
disruption and intensified pressures on the expense of lower quality (and timeliness
life sciences as a result of COVID-19 will having to be preserved for compliance).
have acted as a catalyst for new process
transformation, as organizations look to As PV functions strive to reverse this trend,
cope with additional demands and time harnessing capabilities closer to home that
constraints, and reduced resource availability. make use of accessible and user-friendly AE
automation solutions – whose productivity
In spite of the inevitable delays to benefits are immediate right from case
projects caused by the pandemic, there intake – offers a significant promise.
are encouraging signs that PV and
Safety functions want to do more to As more regular work practices resume
advance their operations, and to improve over the next 12 months, automation
the quality of data and the speed of trends will continue to be an interesting
processing/report delivery in particular. area to watch – and when we come to
measure progress with our next survey
As ever, necessity is the mother of invention, in a year’s time, the findings will be a good
and one of the next priorities for the industry test of companies’ current intentions.
must be to find ways round the roadblock
of system validation which continues
to prevent companies from more readily
capitalizing on the rapid evolution of
next-generation automation capabilities.
15About the research & its respondents. Survey to product.
Conducted independently by Censuswide
in late July/early August, our 2021 Respondents: 200 in total. IntelliCASE.
research – the second annual study in Aged 18+ who are manager level and
this series – polled 200 respondents, in Our second transatlantic
above in Pharmacovigilance, Drug Safety
senior roles spanning Pharmacovigilance, and Product Safety departments survey has again helped us
Drug Safety and Product Safety functions, of pharmaceutical companies: incorporate current thinking
split evenly between the UK and the US.
into the development planning
Across the whole research base, just Small to medium for our case intake and
30.00% triage system IntelliCASE.
under a third of respondents (30 per cent) pharmaceutical
identified their employers as small to
medium pharma companies; a quarter Large pharmaceutical 24.50% As we continue to improve the system,
(24.5 per cent) categorized their so surveys like this continue to help shape
organizations as large pharma; 14 per cent and guide our decisions, ensuring what
Generics 14.00% we create is precisely what PV experts
as generics providers (rising to 19 per cent
in the US alone); 12.5 per cent as clinical around the world are looking for as we
development operations; 11.5 per cent Clinical/Development 12.50% move to far greater automation adoption.
as biotech companies; and 7.5 per cent
specifically as a start-up venture. Biotech 11.50%
In established large and SME pharma A start-up 7.50%
organizations, respondents were more likely
to be in PV or Drug Safety roles. In clinical/ Number of respondents: Country:
development operations and startups, as
might be expected, Product Safety remits 100 UK
were more common, while biotechs had
stronger representation in Drug Safety. 100 USA
The online research was primarily quantitative,
with some scope for open responses.
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17IntelliCASE fits into any pharmacovigilance system.
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19From development to market.
Faster. Better. Smarter.
About us.
Arriello is a leading consultancy and solutions provider of risk management With our extensive global network, decades of combined experience
and compliance services to the pharmaceutical industry. We’ve been making and ISO:9001 certification, we are a trusted partner primarily
the development-to-market process faster, better, and smarter since 2008. to pharmaceutical and biotech companies.
Our global services span the product life cycle from Clinical to post-submission Our valued clients rely on our ability to deliver, however complex their requirements,
Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, through our proven expertise, global coverage, and technology.
and innovative automation solutions.
Headquartered in Ireland, with operations across Europe, we consult and create ISO 9001 certified
solutions across the EU, North America, LATAM, CIS, MENA, Asia, and South Africa.
Service inquiries: sales@arriello.com
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