Seqens eBook - 14
Qualification and Utilization of
CRO Partners
Dennis Jenke, PhD, Chief Executive Scientist
Triad Scientific Solutions
cesses and the scientific and practical requirements for performing these
Final Considerations for the
Screening Stage
activities may extend beyond the technical and/or resource capacities
At the screening stage, the information that is collected is general,
of many organizations that are required to possess such data. To bridge
qualitative and high level as the purpose of screening is not to pick the final
these knowledge and resource gaps, organizations turn to contract re-
CRO but rather to narrow the field of potential CROs to a more manageable
search organizations (CROs) to provide the needed expertise, the needed
number of viable candidates. For example, consider the aspect of essential
capacity, or both."
instrumentation. The question that is being answered at the screening
STEP 2: Identifying and Screening
Potential CRO Partners (continued)
instrumental methods are available at the CRO. For instance, the purpose
Screening for Intangibles
capacity. At this stage, it is less useful to establish the specific instrument
As previously published in Part 1 of this series: "Collection, interpretation,
and utilization of extractables or leachables (E&L) data are not trivial pro-
1
stage is the general question into what and how many instruments and
As important as technical issues might be, there are important nontechnical
aspects that should be considered by a company when it screens for a
CRO partner. The essential issue is compatibility. How compatible will the
contracting organization and the CRO be? Aspects to consider include the
organization's quality systems, its financial models, its relative location,
and its size and culture. It is relatively easy for incompatibilities to exist
between a contracting organization and a CRO, and it is hard to do good
science efficiently when incompatibilities exist. It may be that quality
systems (and expectations) and financial models differ greatly from one
organization to the next. Proximity of the contracting organization and
the CRO may or may not be important, though generally, long distances
are a barrier to collaboration and in some ways limit spontaneity. While
the aspect of size versus capacity has already been considered, there
are other aspects of size that may be relevant. While some contracting
organizations may value a closer relationship with a smaller CRO, other
organizations may be more comfortable working with a larger CRO that
may have a greater depth or breadth.
is to establish that the CRO has LC/MS instrumentation and obtain all of
the essential capabilities of the CRO's instrumentation, including relative
systems and the specific operating procedures. The process of gathering
such detailed information is an investment for the contracting laboratory's
time which may prove to be time wasted if the CRO candidate is rejected.
The screening process must be focused on the type and level of
support that the contracting organization is seeking. If a contracting
organization requires only trace element or metals testing, it would be
relatively meaningless that the CRO has a whole laboratory full of LC/MSn
instruments operated by highly-qualified technicians. On the other hand,
a contracting organization that is looking for a CRO to "do it all" would find
this type of capability to be relevant and necessary.
STEP 3: Qualifying CRO Partners
As the pharmaceutical industry is highly regulated, vendors to this
industry are audited against rigorous quality standards to exercise due
diligence. As vendors of technical services to the pharmaceutical industry,
E&L CROs are subject to the same level of scrutiny. CRO partners who have
survived the screening process must be more rigorously audited than
they were examined during screening. Additionally, it is prudent that the
Lastly, there is the aspect of culture. While divergent cultures in the
contracting organization re-examine the CRO more closely in terms of its
contracting organization and the CRO can be managed and endured,
financial systems and its technical capabilities. A series of actions that are
such a relationship is not optimal and has potential for inefficiency. While
performed as part of the qualification process are listed in Table 1.
it is beyond the ability of this author to provide detailed advice on how
The process of qualifying a CRO requires the examination and exchange of
to assess and score an organization's relationship with a CRO, it typically
information that could be classified as confidential by either the CRO or the
holds true that if something simply does not feel right, then it probably
contracting organization. Therefore, documents that facilitate and control
is not right.
the exchange of such information are a prerequisite to the qualifying
Pharmaceutical Outsourcing |
14
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Seqens eBook
Table of Contents for the Digital Edition of Seqens eBook
Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
Seqens eBook - 5
Seqens eBook - 6
Seqens eBook - 7
Seqens eBook - 8
Seqens eBook - 9
Seqens eBook - 10
Seqens eBook - 11
Seqens eBook - 12
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