One obstacle that can complicate timeline planning for large scale clinical trials is the variability added by conducting trials across multiple countries. Global trials come with more complexity that can’t always be covered by traditional tools like Gantt Charts. Each…   Read more»

The first step should be to identify why the underperformance is happening, which can lead to visits to monitor process or talking to the team themselves to find the root cause. Then the necessary changes can be made to see…   Read more»

One strategy that can be used for keeping clinical research teams motivated is to create and celebrate short-term wins. It was mentioned in this week’s slides that one motivator for people is team based praise, so breaking the project into…   Read more»

@ms3548 I think the way to managing the transition from broad to bottom-up estimating is to treat it as a planned-hand off. For example, scheduling a formal review point once enough detail is available, like a completed WBS or when…   Read more»

In addition to balancing detail and simplicity for the WBS, I think it’s also important the WBS structure has clear traceability between work and regulatory paperwork, like design inputs, outputs, verification and validation. If the WBS is too high-level, it…   Read more»

I agree that regulatory approval shouldn’t be the end all be all for safety. There are multiple strategies that companies can and should take before a product hits the market. One such method is a Failure Modes and Effect Analysis,…   Read more»

In my experience, I’ve used weekly in person meetings in order to make actual progress in a project I’m working and discuss with coworkers. Then I use Slack and some of my free time in order to conduct more research…   Read more»

To build confidence in testing outcomes, companies often create a standardized test kit that includes the product sample, and instructions for handling, storage, and testing. This kit could include things like labeled materials, checklist for covering compound ratios, incubation time,…   Read more»

When facing a late-stage development issue, one method to consider is using the “5 Why’s” Method, where you’re keeping asking why the failure is happening up to 5 times to determine whether the root of the problem is due to…   Read more»

As much as learning from mistakes is important for future projects, it should also be important to use the lessons learned in real-time for decision makings during the project, not just as something to review afterward. If certain patterns emerge…   Read more»

You raise an interesting point, others have mentioned already that EV, PV, and AC only show the symptoms of a project failing and do not explain why. Another shortcoming of earned value management is that it assumes that everyone shares…   Read more»

One common way to foster team and individual developments is through peer mentorship and knowledge-sharing sessions. Less experienced team members are usually paired with professionals, and shadow them to develop skills in real time while contributing to the project. Mentorship…   Read more»

Asynchronous communication offers an alternative for small weekly meetings where everyone meets up for a status update. Instead of having excessive meetings, projects teams use tools like Slack, Trello, or Asana, to provide status updates without needing real-time attendance, allowing…   Read more»

One way to improve QA for medical devices is implementing patient-reported outcome measures (PROMs), which provides a direct pipeline for patients to communicate their experience and outcomes. PROMs allow for personalized insights into how a device performed for them, and…   Read more»

Using Adaptive project governance can help with maintaining a balance between control and flexibility. Instead of every step being micromanaged, a leadership team can set the overall goals and milestones for a project, while the teams doing the day-by-day work…   Read more»

implementing cross-team training programs to promote communication between teams can allow for teams to have a understanding of each groups priorities, and make it less likely that there will be a delay due to miscommunications As for stakeholders, setting up…   Read more»

Using a extreme project management (XPM) framework is one possible solution. It provides a highly adaptive framework that uses rapid iterations and short term dynamics cycles where elements of the project can change based on data and continuous stakeholder input….   Read more»

One approach that some projects use to manage scope creep and task delays is the Event Chain Methodology or ECM. ECM identifies potential event chains that can kickstart due to unexpected events and comes up with contingencies for these event…   Read more»

Instead of having one fixed critical path over the entire project, breaking the work into smaller pieces and having multiple critical paths for each phase allows for some leeway to reassess the next critical path once the current one is…   Read more»