drug discovery & development 13
superior economies of scale); faster time to market companies are attracted to the outsourcing option
(through rapid access to the right skills and the latest because it releases them from unrewarding work which
technologies); and the ability to refocus internal energies distracts them from what they’re good at. The more
to more pressing business activities. involved the document requirements become the more
In many industries, including pharmaceuticals, take- burdensome and off-putting the submissions process
up of hosted software solutions (SaaS) is accelerating, becomes.
offering fast, affordable access to the latest applications.
This has led to the realisation that outsourcing needn’t
Avoiding costly investment
stop there. If pharma organisations are going to entrust The move to eCTD submissions demands new
the management of their software and hardware to a investment, too - in processes and solutions to manage
third party, why not go further the documents, and to ensure that
and let a reputed expert look after the company gains efficiencies
some or all aspects of the broader from lifecycle management. Many
operation? companies, regardless of their
Nowhere does business size, simply can’t afford to build
process outsourcing (BPO) the internal knowledge base and
have greater appeal than in the infrastructure to develop this type
complex and time-consuming of competency.
business of regulatory submissions A better option can be to take a
management, where good experts ‘virtual company’ approach, using
are hard to find, and processes external partners for specialist
have become increasingly onerous, activities, as Purdue Pharma
thanks to the mandate to submit has done. This has enabled the
electronically. The opportunity company to cope with the peaks
to let external experts host and and troughs that characterise the
even co-manage the submissions pharmaceutical industry - handling
process offers significant value. processes internally during leaner
Harnessing the familiar times, yet outsourcing when the
interface of the web, yet with the workload expands, rather than
reassurance of robust security, the hiring additional internal staff.
outsourced solutions allow users As well as being able to
to access, view, edit and share offload the headache of electronic
documentation from their office submissions, outsourcing has
desks as usual. The big difference
Fig. 2. Professional managed services
enabled Purdue to retain a
is that the company no longer
now support every function, from clinical
technological edge by working
needs to own the software, and
trials to post-submission tracking.
with external vendors that
is able to let go of many of the continuously remain ahead of the
processes involved in managing a technological curve. Keep the baby,
licence submission. What’s more, this also gives them the lose the bathwater
opportunity to quickly and easily scale operations up or While some aspects of the development process are
down as market conditions and demand dictates. clearly proprietary (such as data that is specific to a
chemical entity), organisations are not jeopardising their
Lighter means nimbler
competitive edge by inviting in external parties to run
Professional managed services are now available to their more run-of-the-mill functions. Indeed, many core
support every function, from clinical trials to post- processes are common to the whole industry.
submission tracking. The list includes medical writing, The past decade has brought much upheaval to
regulatory consulting and training (Fig. 2). the pharma industry, and the future will bring even
Letting someone else manage these supporting greater change. Firms that have committed to adapt
administrative services could be the key to the dynamism their operations accordingly will find a whole new set of
and agility pharmaceutical companies now need to opportunities to redefine business processes, refocus their
survive and prosper. energies, reduce their costs and sharpen their competitive
As the pharmaceutical industry embraces the eCTD edge.
standard for drug licence submissions, organisations with As for the rest, they may one day find they have to
foresight are seizing this as an opportunity to streamline spend a lot of money playing catch-up – that’s if it’s not
their internal submissions-related processes to achieve already too late. u
multiple gains.
Being experts in the drug development business, Adam Sherlock is Managing Director of Image Solutions
but not necessarily in managing documents, pharma Europe GmbH, Eschborn, Germany. www.imagesolutions.com
www.scientistlive.com
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