opinion 7
duplication, speed processes and improve accuracy. can farm out some of the related, non-core business
The highest priority was noted to be identifying scalable processes, too. Professional managed services now exist
solutions that would grow with their needs. to support almost every function, from drugs application
For the mid-market company, packaged, ‘ready to submissions, clinical trials and post-submission tracking,
go’ solutions have particular appeal, allowing firms to to medical writing, regulatory consulting and training.
get started quickly, while minimising the overall cost But perhaps the biggest plus of all is the flexibility and
of ownership. Having been put off large, complex, scalability offered by the SaaS delivery model. Because
comprehensive document management systems in the firm doesn’t own the IT systems, but merely ‘rents’
the past due to their high cost and unwieldy scope, them, it can switch the functionality on and off (paying
organisations remain keen to adopt systems that are more only for what it uses).
relevant to their size of operations. If a new cross-licensing agreement is reached, or a
With this in mind, and noting that the challenges merger is on the cards, additional capacity can be added
faced by mid-tier organisations extend beyond quickly and easily. This is also an advantage given the
submissions, ISI joined forces storage specialist, EMC, to sheer scope of the molecule-to-market drug development
develop a collaborative, multi-dimensional solution for lifecycle, and the relatively sporadic need for different
this under-served market. The resulting pre-packaged, software systems at the various stages.
integrated regulatory compliance solution, Compliance- The cost of ownership arguments for SaaS are highly
in-a-Box Submission Edition, enables midsize and smaller persuasive. Whereas, in the traditional software purchase
companies to build affordable regulated document scenario, every US$1 spent on a software system
management and compliance solutions. typically generates a further US$3 in validation, project
Since software alone can’t achieve miracles, firms management and resource allocation, these figures are
need to prepare themselves for change and strive to radically reduced with the SaaS model. Here, firms stand
become efficient, streamlined businesses, with defined to eliminate each US$1 in ownership costs along with
processes and centrally managed documents and data. As US$2 of the US$3 spent on administration and support.
long as they continue to foster a silo mentality, with poor Instead, they pay a nominal set-up charge, and a modest
communication between departments and a disjointed and predictable pay-as-you-go service fee.
approach to technology implementation, efficiency, This affordability also means that software
productivity and competitiveness will be compromised. functionality can be employed tactically, for short
Again, smaller firms have the advantage, typically projects, if needed. The ‘rental’ model makes this
being more cohesive and nimble. Add greater document financially viable, because they are only ever paying
control into the mix, and smaller or midsize pharma for the capacity they use, while rapid deployment helps
organisations can exploit this deftness to their build the case, too (while firms implementing their own
competitive advantage. Failure to properly manage software systems internally might have to wait six to 12
information and documents increases an organisation’s months before a new system has been specified, fully
risk of losing or misplacing critical documents and data validated and rolled into production, tapping into a SaaS-
and, potentially, the loss or theft of intellectual property. based system could give them the functionality they need
The ideal scenario, then, favours a shift to a in a matter of weeks).
centralised electronic document management system It’s not just smaller firms that can benefit from this.
(EDMS) and eCTD publishing solution. Even those at the upper end of the market can see the
advantage. Showing just what’s possible, pharma giant
The rise of hosted solutions
Boehringer Ingelheim chose to invest in a SaaS-based
Companies hesitant about being too ambitious, not least system last year because it was rushing to meet the
because of cash flow limitations and a lack of internal fast-approaching deadline for eCTD electronic
resources to manage and support new systems, are submissions.
finding the remotely-hosted, ‘pay-as-you-go’ software Tight FDA deadlines precluded developing an
delivery alternative holds great interest. This offers access in-house system so Boehringer Ingelheim opted for the
to the latest technology without fear of obsolescence, SaaS solution. This not only ensured rapid compliance,
or the burden of having to manage and support the but also allowed the firm to cut internal support costs
IT systems themselves. Costs become predictable and by 40 per cent compared with the alternative. What’s
spread out (and can therefore be planned and budgeted more, Boehringer Ingelheim retained the option to resume
for), while ownership and support of the software and ownership of the systems at any point, giving the firm
hardware systems remain someone else’s problem, complete flexibility for the future.
reducing internal administration costs. Mid-size firms stand to benefit in much the same
For mid-market organisations that need to rein way, particularly as their capital budgets and internal
in expenditure while remaining nimble, this is an resources are relatively modest. u
ideal alternative to making a potentially large capital
investment in specialist software. Adam Sherlock is Managing Director of Image Solutions
If firms want to take the benefits even further, they Europe. For more information, www.imagesolutions.com
www.scientistlive.com
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