I don’t believe any information is transferable from 1 trial to another and patient data protection laws make using it without consent impossible. Technology can be used however to expedite patient selection using digital filtering based on responses similar to job recruiting sites and resumes. Certain psychological tests can be done to reduce for…[Read more]

To answer the first question, we need to look at the factors that influence R. Aside from what the others have said, there is also the companies financial situation and overall business goal. If it is a startup with lots of debt then the R value will be much higher since time is critical factor that will determine if the company stays afloat but…[Read more]

Usually change has a driving factor which comes mainly in the three, not mutually exclusive, flavors; necessity, efficiency, and profitability. In the first situation, change is unavoidable because the product at the moment is either out of spec, fails to meet a required standard, or has a change in risk(usually an increase) that is too great for…[Read more]

So as to not be too repetitive, having a third party review certain key documents that you may be bias towards as well as having different technicians perform testing/assembling according to the testing/assembling documents to ensure they are relatively dummy proof since the worst case scenario could be failure of a product while under…[Read more]

The first step is identifying the type of change being requested. It can be to the BOM, Labeling, paperwork, testing procedures, storing procedures, sterilization procedures, disposing procedure, packaging, etc. Depending on the type of change requested the factors to consider will obviously change. some of the changes may come from revised…[Read more]

One thing to remember is that most if not all companies already have an “Approved Vendor List”, or AVL, for all different products and services that your company may need. The companies on the list are audits in some form by your company periodically (ideally) so that when a project appears that needs something that list is there. If the part…[Read more]

One thing that we need to remember is that successful project execution is not always the end goal, from a corporations standpoint, the end goal is the best way to secure financial revenue and fulfill the commitments made to make that money. In some of the cases listed above the project can be scrapped altogether and a new more encompassing scope…[Read more]

If by project execution you mean the execution plan/phase of the project, then it is safe to assume that the other phases have been completed. At this point in the project progression all or a majority of background research/ investigations into potential issues as well as the dynamics around the tasks delegated have been done. This mean that the…[Read more]

I Agree but the first step should always be understanding the scope of the project because without that you will find new components that need procedures or additional tasks you didn’t account for. The step should also have some form of feedback as mentioned above since feedback is the key to success. Only after defining the scope and consulting…[Read more]

For the given Simulation, the glaring initial problem is the solubility of the carrier in water. while I agree with the previous statements, we need to have a plan of action before we can put them into a Gantt or gain chart. In that case, we need to define the problem that we are facing, the problem we are trying to address and the factors that we…[Read more]

This depends on the financial stability of the company and how important the project you are working on is. If the project is critical and the time restraints are inflexible then going back to a previous phase would allocate resources that would otherwise be used to continue the implementation of the project. With regards to the posters statement…[Read more]

smk45 took the words out of my mouth by mentioning scope. Fully understanding the scope of the project is the first most important thing in reducing risk because unfavorable results can cause delays that can be accounted for when setting the schedule but new factors that require skills or resources outside of the predicted numbers greatly increase…[Read more]

You will find that the M&C is highly correlated to the a properly defined scope. Many of you have mentioned capstone, and I am sure that as you began actually building the product you realized that your understanding of the scope of the project or the time scale for each component based off your understanding of that component from the scope…[Read more]