From groundbreaking medical research to cutting-edge pharmaceutical development, the discipline required to achieve project success in the life sciences industry is unparalleled. These projects demand a comprehensive understanding of the market dynamics, vital capabilities, regulatory requirements, and stakeholder expectations. In this blog, we explore five life sciences project management disciplines and what’s required to deliver a successful project in this industry.
Required Disciplines for Successful Life Sciences Project Management
1. Looking Ahead: Understand and give direction day-to-day, but more importantly, look ahead to what is coming and avoid risks.
In large projects, the immediate deliverables of a project often consume your focus. However, understanding and preparing for the activities ahead is necessary to avoid delays. This requires expectation setting, providing the right tools to perform and analyze progress, resource readiness checks, and consideration of the portfolio of concurrently running projects or system upgrades that may have an impact on your resources, business processes, and integrations. Initial planning involves significant assumptions, and as assumptions are validated, replanning will be required to ensure activities are appropriately prioritized and resources are optimized to avoid “task saturation.” It’s important to establish this expectation with stakeholders at the onset of the project.
In life sciences, change is the rule and not the exception. For example, new product launches or market expansions occur regularly. Changes to the supply network are also ever-evolving. Taking these changes in scope into account while understanding the impacts on both people and requirements is critical to avoid resource constraints and delays to both the project and the business.
2. Scope Management: Follow a disciplined process to ensure alignment with the core best practices maintaining scope and on plan.
When starting a project, the scope must be fully and clearly defined and aligned with key stakeholders, then communicated to the project team. It’s important to identify those few key value statements that are the “secret sauce” that makes the project or company unique and critical to the business. The remaining processes should stick to core best practices. During the course of a large project, change control is important to ensure those value statements aren’t eroded. If the project isn’t carefully managed, scope creep in less critical areas may force a reduction in scope in critical areas. Goals should be established for critical areas to measure success and return on investment – and as always, be sure the goals are SMART (Specific, Measurable, Attainable, Realistic and Timely).
In the life sciences, we must focus on the large critical to quality and key functional items and not get distracted by (the sometimes hundreds of) requests for minor scope changes. Remember, we’re working in an industry that is providing lifesaving or life-changing drugs or devices that must reach the patient timely and intact. Quality, planning, and supply chain are areas where newly identified essential requirements may be given more latitude; however, other functional requirements may undergo increased scrutiny and need to respond to “why not best practice?”
Risk Management: Develop and manage a holistic and prioritized risk management plan, including organizational, process, technical, and financial risks.
Large projects often carry substantial investments and inherent uncertainties; therefore, effective risk management is vital. Identifying potential roadblocks, developing contingency plans, and mitigating risks at every stage of the project ensures a smoother path to success. Having a robust risk management approach established at the onset of a project is necessary to provide visibility to the mitigation plans and activities to address these risks. It also provides a methodology to support escalation when required. An initial risk assessment should occur as part of the project planning process. Large “big rock” items should be addressed quickly. Create a mitigation plan that includes actions and action owners; monitor the progress and share the status at appropriate steering committee meetings to provide visibility; and request support when needed.
Due to heavy regulations within life sciences, regulatory impacts should always be on the risk mitigation plan. During global implementations, local regulations and restrictions must be accounted for during the planning process, and some customization must be considered upfront. However, this is a risk that needs to be watched and checked throughout the project to ensure all regulatory requirements are met and tested thoroughly so that no issues arise during go live.
Another significant risk is vendor engagement. At many life sciences companies, vendors are utilized for contract manufacturing or third-party logistics. The first big risk is contract negotiation and signing for any technical changes that may be required – i.e., establishing EDI (Electronic Data Interchange) communications with, for instance, third-party vendors or contract manufacturers. There may be significant delays due to navigating the legal review process prior to gathering requirements and beginning mapping and building activities. Secondly, availability of the vendor resources and alignment with the project timeline may be challenging as well. These all require early proactive engagement and close monitoring.
Proactive Communications: Create a project-specific structured communication plan to hear all concerns and to ensure teams are informed and audiences are reached.
In project management, it’s important to establish clear and consistent alignment with stakeholders at the onset, including alignment on monitoring and reporting expectations. Defining and understanding what “success” is through the lens of your stakeholders helps to steer presentations and communications. Establishing appropriate forums with frequent check-ins provides an avenue for open and honest dialogue and a path for decision escalations and risk mitigation support. It’s important that communications don’t only go upstream, but that project members and impacted users all require forums to be informed, ask questions, and raise concerns. Effective communication and collaboration foster a shared sense of purpose and accelerate decision-making processes on the project.
The life sciences industry thrives on interdisciplinary collaboration. Bringing together scientists, researchers, clinicians, regulatory experts, and business leaders creates a synergy that drives innovation and expedites project success. Summary-level status may miss the mark when providing updates to program leaders and executive committees who are naturally data-driven. High-level updates don’t necessarily satisfy the natural curiosity and desire for facts supported by detail. It’s important to provide and communicate the appropriate level of detail, ensuring an understanding of the audience when providing updates or requesting support on escalations or issues.
Traceability: Track requirements across the project lifecycle to process, functionality, development, testing, change impacts, and training.
Tracing requirements through the various phases of a project will allow the visibility and assurance that the requirements have been addressed. For successful project completion, addressing these requirements must include three areas:
- People – the business must understand and be prepared to execute each requirement as part of their daily business activities.
- Process – the requirement must work within the existing, modified, or newly established business processes, and this is confirmed by the appropriate scenario definitions with supporting operating procedure to support testing and training.
- Technology – the development and functionality must be built in alignment with the requirements, and each requirement must be covered and verified via various testing cycles.
Requirements traceability is foundational to validation and Computer Software Assurance (CSA) activities within life sciences. In 21 C.F.R. § 820.3, the FDA defines validation as: “confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
“(1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
“(2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).”
Tracing the user and system requirements and validation of both process and system leveraging the risk-based CSA approach will provide confidence and assurance that the solution is fit for intended use. This validation of the requirements traceability will ensure a successful project implementation.
Delivering Successful Projects in the Life Sciences
Delivering successful projects in the life sciences industry demands a differentiated level of execution on the disciplines normally associated with project management. It requires forethought, robust and focused change control, mitigation planning and monitoring, sharing of detailed information and listening, and validation of performance, operations, and installation. By adhering to this approach, organizations can deliver capabilities and improvements enhancing their ability to achieve remarkable advancements in medical research, pharmaceutical development, and healthcare innovation while improving lives worldwide.
For advice on leading successful projects in your organization, please contact us today to learn more about our life sciences project management consulting services.
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