Expert project management that provides transparency and close communication is essential when selecting a bioanalytical CRO. The objective of any project management pursuit is to complete the project on time, within budget, and within required quality or performance parameters. A bioanalytical CRO’s project management capabilities are key to ensuring that a bioanalytical services project runs smoothly, meets regulatory standards, and achieves high-quality results.

To be successful, biopharmaceutical project managers must possess the following skills:

• Robust technical and scientific understanding to lead a technically challenging undertaking
• Ability to understand the role of the project within the overall company and/or industry landscape
• Ability to translate a desired project outcome into an actionable plan that encompasses all project elements, including business objectives, schedules, budgets, resources and balancing these factors to meet the project objective
• Strong communication skills
• Interpersonal skills that allow the project manager to keep the project on track, manage conflict, manage the diverse internal and external subject matter experts (SME) the project requires and the ability to align all stakeholders to achieve the project goal.
• Ability to troubleshoot and redirect project approaches as the need arises

While the bioanalytical CRO project management process is complex, given the likelihood of numerous unknowns, it can be framed into four steps: project definition, execution planning, execution and project completion.

Step #1 – Clearly Define the Bioanalytical Services Project and Potential Constraints

Bioanalytical CROs must clearly define projects. Every bioanalytical services project needs to have a precisely defined goal of what will be accomplished upon successful completion. Correspondingly, every project will be constrained by project scope, time, and resources.

The scope of a given project is the combination of the project’s final goal and the collection of deliverables that must be completed to achieve that goal. The more complex and riskier a project is, the more robust the scope will likely need to be.

Time and resource constraints, including the project deadline, available budget, talent, equipment, and other resources, must also be defined.

The triad of project scope, time, and resource constraints must be carefully and honestly assessed during the initial project planning stages. These constraints must ultimately be well-managed and well-balanced for successful project completion. Because projects virtually never go exactly as planned, the balance of scope, time, and resources usually needs to be adjusted throughout a project. However, these three elements must be carefully analyzed in the initial project definition phase to start the project on the best possible footing.

Step #2 – Project Execution Planning

The most successful project planning communicates and documents all facets of the project through a clear and concise project execution plan (PEP). The PEP thoroughly outlines how project scope, time, and resources will be balanced to achieve the project’s goal. Ultimately, the PEP presents guidance for every pertinent element of the project and illustrates how project team members, sub-teams, externally contracted resources, and other stakeholders will interact to complete the project successfully. Given extensive regulation from the FDA and other regulatory bodies, a strong PEP is particularly necessary for biopharmaceutical projects.

The PEP should include milestones, needed sub-plans, project procurement/supply chain management, project risk identification and mitigation plan, project team plan, communications plan, project budget, work breakdown structure and any other elements that should be documented to assure project clarity. While the PEP should contain all of the above-listed elements, project team creation, project communications plan, risk identification and mitigation are discussed in more detail below.

Bioanalytical Services Project Team and the Chain of Command

The project team must be defined after clearly defining the project goal and assessing the constraints of project scope, time, and resources. The project manager must ensure the team includes the required SMEs to complete each phase of the project and that the SMEs have the bandwidth required. Every project management team member must have sufficient authority and resources to complete assigned tasks and responsibilities.

A project team organizational chart should be created so that all team members know the responsibilities and authority of the other team members. The role of senior management should be defined during the organizational chart creation process. Because every project has challenges and areas that do not go according to plan, a clear plan detailing when and how to escalate an issue to a supervisor, technical expert, member of the executive team, or other personnel should be clearly defined.

Project Communications and Progress Tracking Plan

Effective communication is a cornerstone of successful project management. A bioanalytical CRO must maintain clear and open lines of communication with clients, internal teams, and regulatory bodies. Regular updates on project progress, prompt responses to client inquiries, and transparent reporting are all indicators of strong communication skills.

To ensure effective communication across the project management team, the project manager should regularly assemble and share the following information with the project team:

• Scientific and technical data
• Data analysis and conclusions
• Problems or issues the project team is facing
• Adjustments to project plan based on learning and/or encountered problems
• Status of project tasks and activities
• Timeline and milestone accomplishments versus stated goals
• Costs against budget

Project Risk Identification and Mitigation

Identifying potential risks and creating a risk mitigation strategy is a critical component of balancing project scope, time, and resources to ensure the project objective is successfully achieved.

Inevitably, elements of a project do not go as planned or hoped, particularly with riskier projects. Therefore, a project’s PEP should outline the process for managing needed change. Generally, when unanticipated problems occur, the project scope, resources, or timeline will need to be adjusted to keep the project on course.

When change is needed, the project manager must:

• Communicate the problem and the likely impact of the problem on the success of the project
• Assemble relevant facts, data and analysis
• Draft potential alternative solutions
• Recommend the best alternative
• Communicate with the project team and any stakeholders outside of the direct project team
• Assemble financial and project timeline ramifications to effectively deliver scenarios and ramifications to senior management

Step #3 – Project Execution

The project manager’s challenge during the execution phase is skillfully and adaptively managing change. Even with the most skillful planning, few projects go according to the plan created during the planning phase. Therefore, the project manager must constantly re-plan the project to respond to problems, challenges, and learnings. The project manager’s ongoing role is to effectively balance scope, time, and resources as new situations and evidence present themselves to ensure the project achieves successful completion.

Step # 4 – Project Completion

Much of the work of project completion and closeout should be done throughout the full lifecycle of the project. Documentation, compilation of information needed for compliance and regulatory purposes, and report writing should be done throughout the project. Project financials must be reviewed and analyzed, as well as an objective analysis of the project’s success.

The last and critically important step in any project should be a thorough evaluation. Learnings that can be applied to future projects should be recorded. The primary project team does this review best; typically, a group discussion is the most effective. Including key stakeholders outside of the core project team can be beneficial.

How Prolytix Expertly Manages Projects with PROPath

Much is at stake when choosing a bioanalytical CRO. Prolytix understands that expert project management is essential to ensure clients’ needs are fully supported. Prolytix’s tailored PROPath online project tracking system  provides project visibility, including milestones and key dates, to provide clients with end-to-end project management. The project tracking portal includes percent complete, in-progress, and overdue tasks and links to shared resources. PROPath fosters strong working relationships and ensures Prolytix delivers what clients need on time and within budget.

Prolytix listens closely to understand clients’ challenges and requirements and delivers exceptional quality. As a proactive, flexible bioanalytical CRO, Prolytix openly assesses progress and risks throughout the project to ensure clients’ objectives are met.

Prolytix has a track record of project management excellence. When a threat or opportunity is discovered, Prolytix works with clients to find the right solution and the next best step. Prolytix provides a personalized approach rather than following a traditional project track and can assess project feasibility with maximum agility and flexibility before development. It can also support clients in changing the scope of work to guarantee the right solution, even for clients that have hit roadblocks with other CROs.

With 35+ years of experience, Prolytix has the analytical and bioanalytical services expertise to design and execute the appropriate tests at the highest quality, delivering detailed data outputs for confident decisions.