Pharmaceutical Outsourcing Q3 2023 - 13

CONTRACT RESEARCH
SECTION TITLE
identifying some tangible gains from higher-quality, interconnected
data which, once cleaned and combined, will tell a fuller story. That
might be linking supply chain data to Regulatory data, to enable
serialization, (semi)automated batch release, and mitigation of
shortage reporting, for instance. Or perhaps the aim is to shave a week
off clinical development timescales, or complete eCTD applications or
submit variations more speedily. All depending on the priority and
size of the company.
Map Data Along a Process
Mapping what data exists, and where, is the best place to start with all
of this. It is only through visualizing the current spread of information
assets and associated use cases that companies will appreciate the
potential for greater uniformity and fluidity of data use between the
different departments.
This will help the company establish key processes to transform, for
quick yet potentially far-reaching wins for the business. An effective
map will chart where given data is used along a process including
creation, modification, and re-use by different teams and systems.
Where there is an existing process optimization or digital
transformation team in place, or consultants that are advising on
associated initiatives, these professionals would be the ideal drivers of
a cross-functional data map - in partnership with key functions such
as Regulatory Affairs, Quality, and so on. Companies that have already
appointed Chief Data Officers, or equivalents, will have a head start as
these roles typically take more of a view of the commercial value of
data, where Regulatory Affairs might not be the direct creator of the
data, but more the guardian - as the spider in the web - providing a
more detailed perspective of data's links and touch points.
How to Maintain High Quality Data
A lot has been said and written already about the importance of
improving and maintaining high data quality, as its day-to-day value
in supporting real-time business processes increases.
While some arguments favor a strong sense of data ownership within
specific functions with the most involvement with the given data, it
can be more powerful to encourage everyone across the company to
buy into the value of consistent data so that all functions and teams
play their own part in keeping data clean, compliant, comprehensive
and current.
Effective strategies here involve strong, broad communication of
the associated benefits of robust data, and incentives (recognition
and reward) for those who actively play their part. Instead of data
'ownership', think in terms of a 'chain of data custody' spanning
multiple groups of data processors and guardians over time.
Once companies can more readily visualize their current data
position and the full scale of the task ahead of them - to make their
data work harder for the organization -it's time to decide the most
prudent way forward.
In the case of large pharma companies with extensive product
portfolios and vast system and data legacies, comprehensive data
remapping and/or investing in master data management is likely to
be an overwhelming undertaking that could take many years.
Driving a Culture Shift
Regulators, through their adoption of data standards, are championing
global identifiers for medicinal products and their active
substances. Life Sciences companies that are inventing and developing
these products and substances would benefit greatly from
adopting data standards consistently from early development, and
throughout their marketing authorization/registration information
and variations submissions.
Life Sciences companies have a significant opportunity to enhance
their operations by implementing data standards internally,
facilitating the smooth flow of consistently formatted data across
their processes while eliminating discrepancies and overlap. By
recording data uniformly and sharing it reliably between functions
throughout extended processes, companies can effectively and
efficiently leverage their data to enhance productivity, process agility,
and drive innovation.
There needs to be a sense of shared purpose- for example the role of
improved process efficiency in staying agile, enabled by the ability to
speak the same language internally about products right across the
organization. As long as individual departments all mean something
different with their definitions, there is the potential for risk and
delayed innovation.
Life Sciences is traditionally a very conservative sector so there is a
challenge ahead in achieving an agile culture that underpins data
transformation. Companies must be able to trust data yet allow for
mistakes, be prepared to try something, fail at it, learn from that and
move forward. With the right systems and culture working together,
business process enhancement will be rapid and effective.
Max Kelleher is Chief Operating Officer at Generis and formerly
the company's Head of European Operations. He is passionate
about providing a viable, pragmatic path for modernizing
enterprise information management in regulated industries. His
close work with both pharma companies and specialist solution
partners has afforded him deep insight into the critical modern-day challenges
that traditional approaches to business processes and information use in
complex industries like Life Sciences do not fulfil. max.kelleher@generiscorp.
com https://www.generiscorp.com/
Remco Munnik is a Director at Iperion, a Deloitte business,
and a respected subject matter expert in RIM, eCTD, xEVMPD
and ISO IDMP. He is Chair of Medicines for Europe Telematics
group; and President of the IRISS Forum, a global, open,
multidisciplinary, non-profit networking organization for
life science professionals by life science professionals. Iperion, a Deloitte
business is a globally operating life sciences consultancy firm which is
paving the way to digital healthcare, by supporting standardization and
ensuring the right technology, systems and processes are in place to enable
insightful business decision-making and innovation. rmunnik@deloitte.nl
https://www2.deloitte.com/nl/nl/pages/life-sciences-en-gezondheidszorg/
topics/iperion.html
pharmoutsourcing.com | 13 | July/August/September 2023
https://www.generiscorp.com/ https://www2.deloitte.com/nl/nl/pages/life-sciences-en-gezondheidszorg/ http://www.pharmoutsourcing.com
Pharmaceutical Outsourcing Q3 2023

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