A significant part of clinical development activity is outsourced by pharmaceutical companies, which must still maintain responsibility
for the oversight of the service providers to whom they outsource. Pharma companies fulfill this responsibility through quality
management, which includes precontract and in-process audits of these service providers. Conducting such audits not only requires
significant pharma resources but also significant additional time and resources from the service providers to facilitate these
regular and routine audits from different sponsor companies.
As these audits from different sponsors often seek the same information, it should be possible to use our limited resources
more efficiently. This duplication of effort could be avoided and efficiencies maximized for both sponsor companies and service
providers if sponsor companies entered into a Cooperation Agreement solely for, and limited to, the sharing of objective and
nonproprietary information gained from auditing activities.
The principles of such a Cooperation Agreement would relate to audit scope, what information may/may not be shared, protection
of sponsor's proprietary information, the rights to use audit reports, and respect for existing confidentiality agreements.
Other safeguards built in would ensure that there would be no sharing of information on commercial matters between the collaborating
sponsor companies and no cooperation to achieve commercial leverage. The scope of the Agreement would include only the sharing
of objective information from audits conducted under strict controls and with the prior agreement of the auditee. None of
the collaborating sponsor companies would have the right to access other sponsors' proprietary information during the conduct
and reporting of audits. Once the audit is completed, the objective findings and any related follow-up actions (excluding any reference to proprietary
information) is shared between the collaborating sponsor companies who have the right to cross reference the audit activities
in applications and submissions to regulatory authorities on a global basis.
This initiative has been tested by six big pharmaceutical companies. Benefits for both sponsor companies and about 30 service
providers taking part in the program have been demonstrated.
Quality oversight
A continually increasing and significant part of a sponsor's clinical development activities is outsourced to a variety of
service providers, including:
- full or single service contract research organizations (CROs)
- data management service providers
- laboratories (clinical, bio-analytical laboratories, specialty laboratories)
- central reading laboratories (ECG, imaging)
- clinical trial supplies, storage, and distribution companies
- IVR service providers.
Even with such outsourcing, the ultimate responsibility for the quality and integrity of the work performed always resides
with the sponsor.1 Sponsors fulfill such responsibility through quality management oversight of their service providers, including qualification
and in-process audits. Therefore, the increasing use of service providers by pharma, with concomitant increases in auditing,
still poses a significant requirement for resources from the sponsoring companies and specifically from the auditing functions
of these companies.
Many of the service providers used routinely by pharma are audited by companies often seeking the same information related
to the same generic systems used for activities performed. Moreover, the time required of service providers to facilitate
routine audits from different sponsor companies performing similar audits should not be underestimated. It should be possible,
however, to more efficiently use the limited time and resources of both pharma and service providers and avoid duplication
of effort in quality management oversight.
To avoid this duplication of effort and to maximize efficiencies, F-Hoffmann-La Roche and five other peer companies have entered
into a Cooperation Agreement. This agreement is solely for, and limited to, the sharing of objective and nonproprietary information
gained from auditing activities.
Required resources
Table 1. Time and personnel are two key resources required when a sponsor company conducts an audit.
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Typical resource requirements for pharma to conduct a service provider audit and the resources required of the latter to host
one are provided in Tables 1 and 2.
