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Please submit your questions on outsourcing clinical drug development
using the form at the bottom of this page.
Each month, John R. Vogel, Ph.D., or a guest consultant will post
one or more questions along with an answer.
| Question: |
What are the advantages and pitfalls of creating a central
CRO contracting department at my company? |
| Answer: |
Several pharmaceutical and biotechnology companies have created
"outsourcing management departments" with positive results.
Outsourcing managers perform a variety of functions. They maintain
a database of potential vendors, provide recommendations to
project teams and assist in preparing requests for proposals
(RFPs). They also manage the review of the bids, assist in negotiating
the service contract, participate in problem-solving when requested
by the team, and assist teams in reviewing invoices from vendors.
Some initiatives by outsourcing management departments have
generated cost savings; others have not. Reported benefits include
accelerating contract negotiation through master agreements,
reducing costs through elimination of non value-added services,
and eliminating cost overruns by more closely monitoring vendor
budgets and formalizing change orders. A potential disadvantage
is that the manager may act as a gatekeeper and limit vendor
access to project teams. Also, lack of technical expertise could
limit the manager's ability to evaluate vendors and to assist
in solving problems. Some cost-saving initiatives (e.g., discount
vendor lists) may impose limits on the team's ability to choose
the most qualified vendor. You may find it helpful to contact
The Pharmaceutical Outsourcing
Managers Association. It was founded in 1995 to encourage
the exchange of information among its members. |
Question: |
My company plans to outsource an important phase III study.
The CRO suggests that we use its services to audit the study
and ensure GCP compliance. Is it realistic to have a CRO audit
itself? |
| Answer: |
The notion of a CRO auditing itself raises obvious
questions about the potential for conflict of interest. However,
most CROs ensure the validity of their auditing services by
creating regulatory compliance groups that report directly to
senior management and not to the clinical operations department.
Many sponsors find this to be an acceptable practice. Another
approach is to employ an independent quality assurance and regulatory
compliance group. A recent search of the Drug Information Association
Pharmaceutical Contract Support
Organizations Register under the key words "GCP auditing"
yielded 18 organizations that provide clinical auditing services.
|
Question: |
Are there commercial directories of CROs? |
| Answer: |
The Drug Information Association website (www.diahome.org)
includes a directory of Contract Service Organizations. You
can search by company, service, or by keyword. Several other
directories are available commercially. The CenterWatch Industry
Directory is available from CenterWatch (www.centerwatch.com).
Technomark (www.technomark.com)
publishes regional CRO directories for North America and Europe.
A more selective approach to identifying those CROs best
suited to your particular project is to "prequalify" vendors
according to your specific needs (e.g., therapeutic area,
range of services, geography). The steps in prequalifying
CROs were described in an article entitled, "A Case Study
in Evaluating and Selecting a CRO", that appeared in Applied
Clinical Trials, 5 (6), 30-36, 1996. Reprints are available
at www.pharmaportal.com.
The process is also described elsewhere on this website under
Find Qualified Service Providers.
|
Question: |
My company is currently negotiating a preferred provider agreement
with a CRO. What type of performance metrics would you recommend
to monitor the overall performance of a preferred provider CRO? |
| Answer: |
Preferred provider agreements are negotiated with the expectation
that both the pharmaceutical sponsor and the CRO will benefit.
The sponsor hopes to limit the number of vendors with which
it works and to receive discounts in return for an increased
volume of work. The CRO expects to reduce its business development
costs and to receive a steady stream of work from the sponsor.
Both parties anticipate greater efficiency as they become
more accustomed to each other's standards and procedures.
Some useful metrics for managing preferred provider relationships
are:
- Personnel qualifications (e.g., training and experience
level of personnel who will be assigned to the CRO team)
- Cycle times (e.g., time from completion of a site-monitoring
visit to receipt of the monitoring report by the sponsor,
time from patient completion to entry of the CRF in the
database, time from last patient completion to database
lock.)
- Timing, format, and content of reports
- Acceptable error rates in critical and non-critical areas
of the database
- Billing practices (e.g., how to ensure that pass-through
costs are promptly reimbursed while service fees are tied
to deliverables)
- Efficiency of the relationship (e.g., ratings by the sponsor
and CRO of the quality and timeliness of information for
making key decisions)
Many preferred provider agreements fail to reach sponsor
and CRO expectations because the two parties are not measuring
the "same thing". Sponsors typically focus on process, i.e.,
whether the CRO is doing things "our way". CROs usually focus
on outcome such as using the most efficient approach. For
this reason, it is important that the sponsor and CRO mutually
define the metrics that will be used to manage their relationship.
Some of the metrics will be applicable to a range of projects
while others may be project-specific. Simply imposing the
sponsor's pre-conceived metrics on the CRO is not advisable.
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Pharmaceutical
Outsourcing Forum -- Question Form
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