In recent years, pharmaceutical companies have focused on core competencies and relied on contract research organizations
(CROs) to support their analytical and manufacturing-support requirements.
In today's economic environment, more and more pharmaceutical companies are using the services offered by CROs. Outsourcing
analytical services can reduce overheads by circumventing the need to invest in expensive technology and equipment, thus generating
cost savings for the company. The CRO can provide expertise using up-to-date technology supported by an extensive knowledge
of the current regulations. Outsourcing also can save time, which is often critical because any delay in production processes,
batch releases, or obtaining approvals from regulatory bodies can severely damage a company's prospects.
It is essential that CROs work in close collaboration with their clients, providing smart solutions to their analytical needs,
establishing and transferring methods quickly, and ensuring that information transfer is efficient, secure, and confidential.
The key attributes that a CRO should have to support fast turnaround of projects are the following:
- technical know-how
- experience and a history of successful method transfer
- extensive knowledge of the regulatory requirements
- efficient quality systems with requisite documentation in place
- secure storage and transfer of data
- flexible approach to incorporate last-minute changes.
If a CRO has these core capabilities and maintains a good relationship with the client, it will be able to successfully establish
manufacturing support and batch release methods.
This article highlights the importance of the CRO–client relationship through a case study, which demonstrates how partnership
and support during the project can result in a timely delivery during late-stage development.
A CRO was approached with an opportunity to develop, validate, and transfer several analytical methods to support its marketing
authorizations. The ultimate intention was to use the validated assays for in-process or manufacturing support testing and
batch release. The timelines for completing these projects were very aggressive considering that some of the methods required
did not exist earlier, although the customer already had the reagents in place. Table 1 lists some of the problems that may
arise during contract analysis, and some of the ways to avoid these problems.
Table 1. Key elements of a good CRO–client relationship and how to avoid common problems
The first task was to set up effective lines of communication. At the start of the project, face-to-face meetings were found
to be beneficial. However, telephone and video-conferencing facilities also helped during the initial discussions. The remit
of the project was understood and agreed, because knowing exactly what the client wanted was essential to provide the best
service. The client was asked to provide as much information as possible upfront about the products, processes, supporting
analytical methods, aims, and timelines to avoid any surprises later in the collaboration.
In addition to the technical issues that were discussed, contracts, confidentiality, and technical agreements were rapidly
established to document the project's remit and responsibilities. A single point of contact was assigned at each site to facilitate
information exchange. Any subsequent agreed contractual changes (amendments) were processed quickly to prevent delays in the