One of the complex areas in clinical trial management is handling protocol noncompliance – understanding the line between a deviation and a violation. While violations can jeopardize the entire study, deviations are often viewed as minor and manageable. But in…   Read more»

One element that could be sometimes undervalued in clinical trial management is the Communication Plan. During the Executing phase, consistent and strategic communication with site coordinators can make or break enrollment and data quality. Yet in practice, communication is often…   Read more»

The project management triangle (Cheap, Fast, Good: Pick Two) takes on a level of complexity in the context of clinical trials. Regulatory compliance, patient safety, and scientific rigor limit the ability to cut corners, making it nearly impossible to sacrifice…   Read more»

In cost management, one of the most important decisions is choosing the right estimating method: analogous (top-down) or bottom-up. Each has trade-offs between speed, accuracy, and level of detail. Analogous estimating uses data from previous projects to estimate costs quickly….   Read more»

Time Management is about developing a schedule that reflects real-world complexities and uncertainty. Tools such as the Critical Path Method (CPM) and Program Evaluation and Review Technique (PERT) provide project managers with structured yet flexible approaches to scheduling and planning….   Read more»

One of the important components of project management in medical device development is Project Scope Management, and at the heart of this lies the Work Breakdown Structure (WBS). The WBS is more than just a list of tasks; it’s the…   Read more»

When a potential issue arises near the end of development, deciding whether to modify the product or the process can be challenging. A change in formulation, for example, might fix a biological compatibility issue but it could also trigger the…   Read more»

Different test labs, even when following the same standard (like ISO 10993-5), can produce different results. Differences in sample handling, extract conditions, or equipment calibration can significantly affect outcomes especially in biological tests like cytotoxicity, where subtle changes in extract…   Read more»

One of the challenges in medical device development is managing the tension between technical readiness and market enthusiasm. It’s exciting and validating when a client expresses early interest in a product still under development. This often signals strong product-market fit…   Read more»

The Closing Phase of a project is more than just finalizing deliverables and wrapping up contracts, it’s a critical opportunity to capture lessons learned and improve future project performance. Many teams overlook this step, eager to move on to the…   Read more»

Change is inevitable in any project, but how it is managed determines whether it leads to improvement or chaos. The Change Control System ensures that modifications to a project – whether to the scope, schedule, or budget are evaluated, approved,…   Read more»

Monitoring & Controlling ensures that a project stays on track in terms of scope, budget, schedule, and quality. Without proper monitoring, teams may not identify potential risks or deviations until it’s too late, leading to costly overruns or delays. A…   Read more»

During the project execution phase, team development is one of the important processes to ensure the project stays on track and meets its objectives. A well-developed team is not only more efficient but also more resilient when it comes to…   Read more»

Timely and effective information distribution is essential for executing a project successfully. It ensures that all stakeholders, including team members, suppliers, and leadership, have access to the latest project updates. Without structured information flow, miscommunication can lead to delays, redundant…   Read more»

Scope verification is an important component of the Executing phase in project management, ensuring that the project deliverables align with the agreed-upon scope. While often confused with design verification, scope verification is about confirming that the project is producing what…   Read more»

The case study on Injectable bone growth factor syringes highlight the importance of adaptive project planning, especially in research-driven product development. Instead of following a strictly predictive (waterfall) approach, adopting an iterative development model like Agile or Stage-Gate hybrid approach,…   Read more»

In the Injectable bone growth factor syringes project, BoneFix is dependent on FactoSet’s expertise in biologics, while FactoSet relies on BoneFix’s market reach and distribution capabilities. However, achieving a seamless partnership requires effective communication and shared responsibility. Project teams in…   Read more»

One of the challenges in the Injectable bone growth factor syringes project could be ensuring that all stakeholders stay aligned throughout the development process. The agreement between BoneFix and FactoSet imposes milestone requirements, which means any delays or misalignment could…   Read more»

Cost estimation is an important aspect of project planning, but it is often one of the most difficult to get right. A common pitfall is estimating costs before fully defining tasks, leading to inaccuracies that can disrupt the budget. Another…   Read more»

A schedule ensures that tasks are sequenced logically, dependencies are accounted for, and resources are allocated efficiently. Techniques like the Work Breakdown Structure (WBS) and network diagrams help identify task relationships, while tools like the Critical Path Method (CPM) ensure…   Read more»