1. Pharma Bio World August 2013  19
What to Expect from a CRO?
T
he title of this article begs another
question first. Why a do we
need a CRO (Contract Research
Organisation) for drug development, is
it essential? All pharmaceutical firms
including large MNCs require assistance
from CROs to expedite development of a
new drug or product to reduce costs and
in most cases to exploit CROs domain
expertise. CROs also provide the variety
and number of investigational sites with the
required training and qualifications that the
investigators ought to have.
Large biotech companies have such
complex and back and forth development
processes that it pre-requisites a CRO’s
support in product characterisation and
clinical testing at numerous stages. The
mid and small sized pharma companies
often do not have either a full-fledged
pre-clinical and clinical R&D or the generic
pipeline is too huge to be handled on
their own.
Thus in addition to provide expertise,
knowledge, equipments and facilities,
CROs can share the responsibilities (by
means of transferred authority) of drug
development with favourable timelines
and regulatory assistance. There are,
however, potential risks involved in all
outsourced works to CROs. Other than
losing direct control of the projects,
there are risks of poor or irrelevant data
generated, GXP violations, fraudulent
conduct of study and missed timelines.
Poor communication and relational
dissatisfaction could be other hassles
involved in outsourcing.
There are organisations
who have thoroughly and
quantitatively surveyed the
various areas of sponsor
expectations and whether
various CROs meet them
or not. Such surveys
provide very interesting
data that can help strategic
alliance and relationship
management between
sponsor companies and
CROs.1
The author of
this article has mainly
alluded to his experiential
qualitative data in writing
this article.
Twofold Relationship: Contract and Trust
Contracts define the legal and task
obligations of a CRO that is expected
by the sponsor. Thus, the practical and
commercial aspects of the relationship
between the sponsor and the CRO revolve
around what has been clearly embodied
and appended in the contract. Anything
that is not clearly written in the contract as
a deliverable by the CRO, will be treated
as a non responsibility of the latter in a
court of law. In fact one of the first things
to be expected from a CRO is a contract
that is clear and unambiguous in terms
of deliverable and has been written in
good faith.
The wholesome and long standing
relationship between these two entities,
however, cannot be entirely contractual
in nature. It is actually based on mutual
trust as any good relationship is. Trust in
and of what? The sponsor trusts that a
CRO will deliver quality studies and data
as mentioned in the contract within the
stipulated timeline. In return, the CRO trusts
that the sponsors will co-operate with all
necessary information, especially thorough
objectives and study protocols, make
milestone and final payments on time and
will not micro manage their projects while
being conducted by the CRO. Asherman
and Sagotsky have looked into the
potent role of trust in successful to “best”
sponsor-CRO relationships.2
Effective
communication plans should be evolved
such that detail processes for discussing
performance expectations, releasing
undue pressures and for escalation of
Dr Bhaswat S Chakraborty
Sr Vice President
Research & Development
Cadila Pharmaceuticals Ltd
“
“
Anything that is not clearly written in the
contract as a deliverable by the CRO, will be
treated as a non responsibility of the latter in
a court of law.
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2. Pharma Bio World20 August 2013
Understanding the continuum is likely
to enhance the satisfaction at all levels.
Gains in delivery- and other critical
project-timelines constitute the most
discernible improvement in efficiency.
Improved timelines are best appreciated
when the budget and the scope of
the project have not been changed
disfavourably for the sponsor.
Improved efficiency over time with
monitoring of the CRO activities is a
positive sign of a successful sponsor-
CRO relationship. This also eliminates
micro-management of the CRO which
often poisons the relationship. Clarity
of all milestone activities and the scope
of data analysis should be understood
by the CRO such that all supervisory or
issues through the governance structure
are practised honestly.
Expect Value, Quality, Guidance and
Satisfaction
No matter how genuine the long term
relationship between a sponsor and a
CRO is, the latter is ethically and legally
bound to deliver value and quality in
conducting studies. Value in this context
is benchmarked science, following the
appropriate guidelines, GXP compliance
and timely delivery of projects. The
quality is the integrity and accuracy of the
data. The quality applies to both valid in-
process and analysed data, and its correct
interpretation in the reports prepared.
Reports must be in the regulatory
friendly formats (eg, CTD). The major
expectations and underlying needs met
provide the level of expectation that the
service receiving sponsor will experience
(Figure 1).
The Efficiency Continuum: Meeting
Timelines within Scope & Budget
Efficiency is a multi-significant term but is
mainly used for timeline, supervision and
process improvements. Efficiency is also
a continuum rather than being discrete,
arbitrary numbers on a scale.
review elements are exactly known by the
latter. This will reduce overseeing and
duplication dramatically.
Many CROs may specialise in process
improvement which may culminate into
generation of intellectual property rights.
The exact duration of relationship that
will lead to improved process efficiency is
rather difficult to predict as it depends on a
multitude of factors.
Regulatory Compliance
Except for a very small percentage of
the projects, all activities outsourced to
CROs are expected to follow applicable
regulatory requirements.
The good practices including GMP, GLP
and GCP must be in compliance with
following mutually agreed upon SOPs. QA
and QC must be vigilant and assuring to
the sponsor.
In addition to championing the compliance
with GXPs and other regulatory
requirements, all sponsors expect that the
CRO, that they have outsourced to, will
be able to quickly receive a local trial or
manufacturing license.
The CROs are also expected to know the
nuances of the local regulatory agencies
in terms of pre-requisite data and the time
required for receiving the approval for
trial conduct in details. The performance
standards of regulatory agencies are
different in various countries. Slower
approval times warrant a better planning
and preparation for the projects.
Figure 1: Schematic representation of the satisfaction gained by the sponsors when their needs are
met at different levels and cumulatively.
Table 1: Top 10 Expectations from a CRO
1. Competitive cost or clear cost advantage & adherence to budget
2. Timelines management within defined scope and budget for the project
3. Quality control and quality assurance
4. Regulatory compliance & strategic advice
5. Documentation in standard (international) formats
6. Low attrition rate of CRO personnel
7. Availability of adequate number of personnel in all pertinent areas
8. Involvement/intervention of senior management whenever necessary
9. Scientific and technical advice
10. Customer satisfaction assurance, metrics of satisfaction
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3. Pharma Bio World August 2013  21
a partner CRO. However, this is not the
general reality. The heart of the problem lies
in the lack of an effective implementation
of the partnership programme. Frequently,
the drive to save resources and costs
that led to strategic partnering in the
first place inhibits upfront investment
in the relationships. For example,
while it is acknowledged that frequent
communication, face to face meetings,
and training programs contribute to the
success of implementation of strategic
relationships, pressure to conserve costs
often prevent these from taking place.1
Conclusions
We have examined the nature and levels of
expectations that a sponsor pharmaceutical
or Biotech Company or any other
relevant entity may have from a contract
research organisation. The expectations
are based on mainly three parameters,
namely, scientifically accurate conduct
of the project, regulatory compliance and
meeting the success metrics in terms of
time, scope and budget. The experiential
data and published surveys point out that
the relationship between the CRO and a
sponsor must be based on honest faith,
transparent and well written contract
and mutual cooperation. The levels of
satisfaction gained by the sponsor will
depend not only on the selection of the
correct CRO but also on meeting mutual
goals, promises and milestones and on
excellence of communication.
References
1. The AVOCA Group (2010). 2010 Avoca
Report Executive Summary. http://www2.
theavocagroup.com/knowledge-center/
reports/2010-avoca-report-executive-summary
2. Asherman IG, Sagotsky B. (2009). Trust-
Based Influence and the Sponsor/CRO
Relationship. The Monitor (Association of
Clinical Research Professional Journal),
August 2009: 35-39.
3. Applied Clinical Trials Online (2013). 9th
Annual Avoca Industry Survey Results.
http://www.appliedclinicaltrialsonline.com/
appliedclinicaltrials/article/articleDetail.
jsp?id=807740
Contact: drb.chakraborty@cadilapharma.co.in
Learning Together: Mutual Respect
This article would be incomplete if
mutuality of responsibilities and roles is not
mentioned even though the theme of this
article is kind of unidirectional (sponsors
expectation of CRO). As mentioned
in the previous paragraph, successful
delivery of a project is not only the CROs’
responsibility it is also an accountability
of the sponsor. How so? Firstly, trust,
respect and learning together will bring the
members of the sponsor and the CRO team
together. Finally, in last two decades or so,
many refinements came through mutual
discussion and subsequent joint designing
of the projects by the aforementioned
two stakeholders.
Expectations that Lead to Success
Table 1 enlists the main expectations
that need to be met for successful CRO
projects leading to at least an appropriate
regulatory submission. At all stages of
a project or multiple projects, robust
systems for measuring performance
and relationship are very important.
Particularly important are metrics that
reflect status in an ongoing manner and
that are therefore actionable during the
course of a study.3
Successfully Met Expectations
In a survey conducted by Avoca group, it
was found that nearly half of the sponsors
had strategically entered into partnership
with CROs. The most common objectives
for launching these partnerships included
reduced costs, improved quality, improved
efficiency in use of internal staff, access
to operational expertise, and process
improvement. Among sponsor respondents
whose relationships spanned a period of
more than 3 years, there was considerable
variability in whether expectations in each of
these areas were met, and in the time it took.
For example, over half of the respondents
achieved cost savings in one year or less,
although, about a quarter reported never
achieving cost savings. Additionally, about
half of the sponsors achieved improved
quality within one year; however, nearly
20 per cent reported never achieving
this. Similarly, process and efficiency
improvements were attained by a little more
than one third of the respondents.3
Unmet Expectations
It has been observed that in poorly
performing strategic relationships, the
sponsor management is convinced that
they simply made the wrong choice of“
“
Successful delivery of a project is not only the
CROs’ responsibility it is also an accountability
of the sponsor.
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