SubscribeManagement of outsourced pharmaceutical development projects, and ensuring compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) requires a different range of skills to managing in-house programmes.
Clients and contractors may have different perspectives on project scope, timelines, expectations and GMP/GCP requirements. A manager of an outsourced development programme must ensure that his cultures and perceptions merge with those of the contractor. Building a good relationship with your pharmaceutical contractors can go a long way to deciding whether your development project will succeed.
With a conventional, in-house, pharmaceutical development programme, all staff will know the culture and expectations of the company and the background to the project. A manager can easily check on progress, by both formal and informal means. The company will have its own quality systems to ensure compliance with current standards of GMP or GCP. However, pharmaceutical contractors will have a different background.
They will have worked for a range of companies, all of whom do things differently, and will have formed their own culture and ways of working. This is even more marked when the contractor comes from a different country or continent and has a different personal culture or language. There are many examples where this has led to misunderstandings, misinterpretations and mistrust between contractors and their customers.
Pharmaceutical contractors will also have their own project priorities. Their management may decide that another company's project is more important, for whatever reason, and yours may be pushed into the background. One of the tasks of a manager of outsourced pharmaceutical development projects is to motivate the contractors to give priority to your project.
The most successful outsourced pharmaceutical development projects have involved a collaborative or synergistic relationship between customer and contractor. There is a strong team spirit between the parties, each thinks that their input is valued, problems or difficulties are discussed openly, and each feels some ownership in project success.
The customer knows their project or product and what they want to achieve. They know the quality success criteria they wish to achieve. The contractor will have experience in carrying out similar projects and may well be able to suggest improvements or identify likely problems.
The basis of this approach is to be interdependent and to trust each other to do the best for the project. Both parties have a stake in project success, and neither will want to do anything which will prejudice this. Good relationships and open communication channels between staff at the customer and the contractor will lead to increased motivation and a successful project conclusion.
This method is usually used by the most successful of the virtual pharmaceutical development companies. They usually have core staff experienced in key areas such as development, quality assurance, preclinical, clinical, regulatory affairs etc.
These people define the project strategy and quality standards and find and manage the contractors. The contractors have the facilities, equipment and trained staff to be able to carry out the practical work. If any problems arise, they can be discussed between experts at both the customer and the contractor and clear agreement reached quickly.
Smaller or emerging companies will not have the resources to employ full-time experts in all of these areas. These companies employ specialist consultants to advise their internal project managers and manage the technical aspects of projects.
The consultant is responsible to the development company, and will ensure that the contractors will achieve the required quality and success criteria. The company only needs to pay for the time the consultant is actually working on their projects, so overheads are lower than the cost of a full-time employee.
These specialist consultants have expertise in a wide range of development activities, and will know which contractors are likely to be most suitable for a particular project. Amongst the tasks which these experts can carry out for their clients are:
- Drafting requests for quotations (RFQ)
- Short-listing of potential contractors
- GMP/GCP auditing and selection of contractors
- Contract negotiation
- Technical project management
- Troubleshooting and problem solving
Regulatory authorities increasingly consider that clinical trial sponsors must take responsibility for work outsourced to contractors. If contractors and their customers are not working in harmony, projects may be late, overspent or carried out to inappropriate quality standards. Who's running your projects?