Contract laboratories should make available a brief written summary report available before project update meetings or conference calls. These events are interactive, with ideas exchanged and decisions made by the client and contract laboratory. They are especially useful for method development, transfer, and validation activities. For larger studies, a more formal review of the entire program, typically on a quarterly or biannual basis, is recommended. This enables both parties to take a step back and look at the "big picture" of which areas are working well and which need improvement. They can then evaluate performance metrics (such as turnaround time, timelines and budgets versus goals, and quality metrics), recommend systems and process improvements, and discuss the future of the program.

After completing the outsourced study, assessments of the contract laboratory's overall performance and the interactions with client can take place as a "lessons learned" meeting. An evaluation of key performance measures in terms of technical skills, project management, quality, and communication is conducted. The outcome is often communicated to the upper management of both parties in an effort to improve performance of quality systems and processes in both organizations. This feedback helps clients understand what improvements can be made to manage their outsourcing partners more effectively.

It is the project manager's responsibility to coordinate and drive these meetings, act as the meeting facilitator, prepare the meeting agenda, document and distribute meeting minutes, and follow up.

Risk Management

Key to the effectiveness of project management is proactively identifying potential impediments to completing the study in a timely and cost-effective manner. A simple technique to aid in this type of risk management is to ask the following sample questions:

• Does the study involve an early phase of drug development?
• Is the drug formulation going to change?
• Is method feasibility or transfer going to be conducted prior to sample analyses?
• Does the laboratory have experience with a similar compound?
• Is the client contact knowledgeable about the analytical portion of the study?

The next steps involve prioritizing the risks in order of probability and magnitude of impact on costs, quality, and timelines, and then formulating a risk management plan. The plan should list strategies to mitigate risks, persons responsible, and timetables for implementation, resources, assumptions made, and ways to measure effectiveness.

Escalation and Resolution of Issues

Every outsourced project has its share of problems and issues. It is wise to devise a plan detailing when and how to escalate an issue to the next level supervisor, technical expert, someone from upper management or quality assurance, or client. Although there are no hard-and-fast rules, the following are some of the warning signs that someone of greater authority or experience should be consulted:

• Timelines are going to be compromised
• Client has started to express concern or dissatisfaction
• Several attempts or approaches at resolving the problem have failed
• Expertise within the team is limited.

The project manager's role is to inform the client of the problem in a timely manner and facilitate the resolution of the issue. Trust and confidence in the contract laboratory's abilities and the nature of the relationship between the client and the contract laboratory can make a major difference in outcome.

A Corrective and Preventive Action (CAPA) plan is an integral part of resolving the problems encountered. The plan identifies root causes and an action plan is designed around systems, processes, and procedural improvements. In addition to the "who," "what," "how," and "when," components of the plan, it also includes a follow-up strategy and ways of measuring and monitoring its own (the CAPA's) impact.

Hypothetical Case Study

The case study below illustrates how project management approaches can lead to a successful outsourced biopharmaceutical program.