The principles of the Cooperation Agreement that effect the service provider relate to audit scope, what information may/may
not be shared with whom and when, protection of the sponsor's proprietary information, the rights to use audit reports, and
respect for existing confidentiality agreements. This is detailed in the standard service provider letter of consent, which
also provides the identity of the sponsor companies with whom the report will be shared and which must be signed before any
audit report is shared. Audits are conducted in accordance with the normal SOPs of the auditing company who will have access only to its own information
and will not have right of access to proprietary information of the other sponsor companies during the conduct and reporting
of these audits. All conditions of confidentiality agreements between the service provider and any of the named collaborating
companies remain fully in force and nothing in this process shall be in conflict to this. All proprietary information related to the auditing company gathered through the review of documents and relevant interviews
is used to test the generic systems (people, processes, and equipment) of the service provider that are also used routinely
during the provision of similar services to the group members who have signed the Cooperation Agreement. The detailed scope of the audit will be described, as usual, in the audit confirmation letter sent by the auditing company.
Upon completion of the audit, the objective findings and related follow-up actions (excluding any reference to proprietary
information) will be discussed with the service provider, and only then will be shared between the named collaborating sponsor
companies in a standardized process. In this way, the nonauditing group members will only see the audit report when it is
completed in the context of the auditee comments and provision of follow-up action plans. These shared audit reports and follow-up action plans may be transferred within the individual group sponsor companies in
a controlled manner and to the extent that this is already allowed in the individual agreements between the service provider
and individual sponsor companies. A key element of the collaboration process, and of benefit to both the group of sponsor companies and service providers alike,
is the focus on standardization of audit conduct and, in particular, standardization of interpretation of audit reports. Progress to date Six big pharma companies have joined forces to share the generic results of some of the cyclical routine audits each conduct,
thereby obviating the need for the other five to conduct the same audit. All have significantly benefited from significant
cost and time savings. These audits have been conducted in Europe, the United States, and Australasia by group sponsor companies.
About 30 service providers have signed up for the program and have also begun to see the benefits of time and cost savings
comparable to those seen by big pharma. Future outlook It is clear from the initial proof of concept phase for this initiative that by increasing (in a controlled way and with the
consent of all present parties) the number of collaborating companies in the group, we can even more efficiently share limited
resources involved in the strategic risk management of independent third-party service providers of common interest. It is envisaged that a controlled expansion phase of the project to allow, at least initially, for up to 10 collaborating
QA groups will enable all parties participating to derive even significantly more benefit. The number and size of participating
service providers are not limiting factors, but the type of service provider is. Specifically, investigator sites and clinical
pharmacology units are not suited to such a program since such audits may be of a more project orientated and proprietary
nature. In addition to maximizing efficiencies and avoiding duplication of effort, it is also envisaged that this initiative will
encourage the development of auditing criteria and standards so that audits become more standardized in the ways they are
conducted and the kind of issues they are trying to assess. Challenges still remain both within pharma and within the service
provider sector. These challenges include the conservatism of especially those pharma companies that could contribute to and
benefit from maximizing the initiative, as well as an unfounded fear by the service provider of collusive discussion to exert
commercial leverage. However, progress to date is showing that these barriers are being broken down. Brian O'Neill, PhD, is global head of CQA external alliances at F-Hoffman-La Roche Ltd., Bldg. 670/515, CH-4070 Basel, Switzerland, email:
brian.oneill@roche.com
. 1. ICH GCP Part 5.2 Contract Research Organization, http:// http://www.fda.gov/cder/guidance/959fnl.pdf.
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