Clinical Outsourcing
Q.
We always keep sponsor requirements for of our revenue base, helping us a great deal
Do you welcome the MHRA’s Phase I
study expertise under review and respond from a strategic perspective. Another major
accreditation scheme which came into effect
as required; paediatric expertise, for example, success of 2008 has been our EDC platform
recently?
is a developing area. Building further areas of partnerships with both ClinPhone [now Parexel]
therapeutic strength remains a priority for us. and Medidata. More than 70% of our studies are
Yes and no. It is important that the accreditation now going into an EDC platform; we see this as a
system establishes a “gold standard” for Phase I
Q.
tremendous success.
Why would a company choose to
within the UK, applicable to all sectors of clinical Other highlights have been the integration of
research (NHS, charities and industry) alike.
outsource its clinical research to you?
DDS to strengthen our Early Phase brand and I
However, in order to further improve the UK’s think what we’ve seen overall is validation of the
position of f_i rst-in-man studies from a global
We have a good geographic network, strong
globalisation and the focus of Chiltern in servicing
perspective, the regulatory review process for
expertise, highly controlled process, modern
our clients’ needs. We’ve seen signif_i cant revenue
investigational products manufactured outside the
systems, well trained people and a hands on,
growth of around 25% and a very signif_i cant
EU needs to be more commercially realistic. The
‘can-do’ attitude. We are continually thinking
increase in sales, so we have conf_i dence in our
industry has addressed this issue with the MHRA.
about what we can do better and have a variety
model moving forward.
of different models available which would suit all
Q.
clients’ needs. There is a real sense of enthusiasm
Do you think any improvements are
in the company as we continue to develop. I think
Q. What are your longer-term ambitions for
needed in the regulatory infrastructure
sponsors recognise and appreciate these features
the company?
governing the world’s major markets?
and reward us with their trust.
Although we’re not seeking to be the largest
We believe the European and US regulatory
Q.
CRO in the world, we’d like to stay at the top
Do you have any long-standing strategic
environments are suff_i cient to provide a safe of the middle tier and continue to grow in a
and ethical forum for the development of
client partnerships at the moment?
sustainable and successful manner. And we will
investigational medicinal products. However, do that through a combination of organic growth
variations between national territories call for
We have a number of successful and
and acquisition, but in the longer term we are
experienced handling of the pan-European
collaborative long-term relationships, but it’s
really intent on continuing to build stronger client
regulatory arena in order to ensure that
really been over the past two years that we
relationships and making Chiltern a successful and
assessment time, multiple standards of care
have seen more partnerships of the sort you
great place to work for our people.
and cultural evaluation of protocols meet
refer to. While a lot of outsourcing continues
clients’ expectations.
to be done on a tactical basis, we have entered
The US FDA has strengthened its position
into several strategic outsourcing partnerships
Q. How has the credit crunch affected your
regarding post-marketing commitments
and are seeing these relationships move in two
business and the CRO sector in general?
by sponsor companies. We believe there
different directions.
is a need for the EMEA and the European
One direction is partnering where we run all
There has been considerable discussion
Community also to critically evaluate and provide
or part of a pipeline of trials. These trials may be
recently about the impact of the tightening
formalised guidance in this area. Our clients are
managed and staffed exclusively by Chiltern staff
of the capital markets on biotech VC funding,
proactive and are really pressing forward with
or may be a hybrid approach where we manage
pharma pipelines and ultimately on outsourcing
commitments. But the legislators in Europe
aspects of the trial and provide staff to pharma
to the pharmaceutical services sector. In short,
are less equipped to deal with that on a pan-
aff_i liates, via our Resourcing Solutions group, to
we have not seen any impact to date either in
European basis at present.
support projects.
terms of cancellations or a slowdown in new
The other form of partnering that we’ve
business volumes.
Q.
seen is functional service provider outsourcing
The CRO sector appears to be growing at
How is Chiltern’s client work broken
(or FSP) partnering, ie, Chiltern running and
a steady rate and has benef_i ted from cost-
down by therapy area and clinical phase?
staff_i ng internal departments or supporting
containment initiatives and the drive to outsource
a service within sponsor companies. For us,
from within the pharma sector. I would expect
We work across a wide range of therapeutic
this has taken the form of running a European
this to increase over the next few years. However,
areas, our largest being oncology, which makes
pharmacovigilance team for a large pharma player,
I don’t believe any sector is bullet-proof in tough
up about 20% of what we do. Respiratory, CNS
running a global EDC implementation team
times and we will certainly watch how this plays
and cardiovascular trials make up around 15%
for two large pharma companies or wholesale
out with great interest.
each and infectious diseases around 10%. We
staff_i ng of clinical development departments.
With respect to consolidation, there has been
also have a strong presence in ophthalmology,
Clearly many companies in the pharma
a drive to globalise CRO services with a focus on
although that is a relatively small area of
sector are facing R&D cost pressures and drug
expanding our therapeutic expertise, our global
research. To support these efforts we have
development challenges, driving the current
reach and the quality of our service. Additionally,
established f_i ve specialist therapeutic area
trend for outsourcing and cost-containment. It’s
with further consolidation within the pharma
teams, with a sixth, devoted to cardiovascular, in
also clear that the CRO sector, in supporting its
and biotech sector this will inevitably lead to
preparation. The teams look at study feasibility
pharma clients, is benef_i ting from that and we’ve
consolidation within the CRO sector. We intend
to ensure superior country and site selection,
been a player in this space.
to be a player in this space and will, of course,
develop training templates for use by our consider all strategic alternatives necessary to
project teams and develop deeper relationships
with our clients and sites aligned to a particular
Q.
improve our position in this busy arena.
What were Chiltern’s main successes
therapeutic area. of 2008?
The Early Phase business presently brings
in around 5% of our revenues, Global Clinical Our major successes have been the acquisition
Development around 48%, Biometrics 14%, and integration of CTMS in North America,
Resourcing Solutions 24% and Late Phase around which has transformed Chiltern into a more Caroline Richards is a reporter for Scrip.
5%. The remainder is regulatory affairs work. global CRO. The US now delivers around 30%
www.scripnews.com/supplements Scrip 100
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