Also helpful is a checklist outlining key pieces of information needed to determine pricing, timing, and resource requirements.
The contract laboratory's bid (proposal) should indicate explicitly what is, and is not, included in the fee, and assumptions
should be stated clearly in the contract to clarify terms and conditions. For example, if a start date is agreed upon, one
key assumption is, "initiation of the study is contingent upon receipt of samples and standards and approval of the protocol
by the client." Assumptions are also essential to include in the bid when the responses to certain key questions in the project
definition form are unavailable or not provided. Ideally, the project manager is engaged as early as possible in the bid preparation
process, because the contract serves as the foundation for developing the project and resource plans.
The Project Team and Resource Management
Assembling a project team for an outsourced biopharmaceutical study occurs early in the project, even before presenting a
bid to the client. In order to commit to taking on a study, the contract laboratory must have formulated a resource plan.
In determining the resource requirements for the study, the project manager, along with the operational leaders, should consider
the following:
- Experience, expertise, and training of the staff based on the techniques, methods, and compound(s) involved
- Previous experience of the staff in working with the same client
- Support functions such as quality assurance, technical writing, sample management, and stability storage
- Availability of staff and equipment based on approximate time frame
- Back-up staff in case of vacation, illness, or other unexpected events
- Back-up equipment in case of downtime.
It is in the best interests of the client and the contract laboratory to maintain a dedicated team for the project. This establishes
"ownership" and accountability. It also promotes consistency in the results. Throughout the study, the project manager monitors
the use of resources against project timelines, budgets, and study requirements, and recommends necessary adjustments to resources
and timelines.
Project Communication Tools
Table 1b. Project management communication summary
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Several avenues of communication should remain open during the lifetime of the program to guarantee an effective relationship
between a contract laboratory and its client. Meetings, as summarized in Tables 1a and 1b, are essential to accomplish project
management objectives. Aside from the project definition meeting, project initiation or kick-off meetings, both with the client
and within the contract laboratory team, are critical tools for project management communication. Equally important during
these meetings is establishing roles and responsibilities of project team members, lines of communication, guidelines for
escalating issues when needed, and ways to handle investigations and deviations, as well as changes in project scope, timelines,
and budgets.
Communication at the contract laboratory during the method transfer or method evaluation stage is crucial. Often, test methods
for biopharmaceutical products are initially developed by the client or at a contract manufacturing facility. The sponsor
should be certain to communicate all relevant information about the history of the methods, steps that are technique-specific,
and other methods that were evaluated or that the sponsor attempted to develop (whether successful or not). Challenges in
robustness and reproducibility of biopharmaceutical techniques are often encountered when methods are transferred from one
laboratory to the other. Sharing relevant information through project management communication tools ensures seamless and
efficient method transfer.
To keep the communication lines open among all parties while the study is in progress, the project manager should provide
status updates to the client on a regular basis, containing the following information:
- Technical data
- Data analyses
- Data interpretation and conclusions
- Technical issues
- Future experiments
- Status of project tasks and activities
- Timelines against goals
- Costs against budget
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