When preparing a budget for a clinical trial you need to perform an internal cost analysis by evaluating your study specifications and determining exp...
Resources, budget,responsibilities and skills are main factors to determine how to manage a project in a small or a large company. Effective project m...
Deciding on when to outsource clinical trial or insource depending on the project, capabilities and resources needed. I think insourcing is more expen...
When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and ope...
Example: Placebos Study Placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’l...
Actually AMDD very useful class. I learned a lot about the regulations and QSR in US and regulations in EU as well. Participation & Simulations gr...
For me I will choose CRA , as a CRA you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is...
Motivation for a project manger is the key for success also Communication is another important key for a project manager. Project managers must commun...
For me I would like to work as an engineer and after 4-7 years I would like be a manager. Also, I think after getting more experience in the field I c...
The definition of A Significant Risk (SR),is a device presents a potential for serious risk of health, safety and welfare of a subject, and are intend...
clinical trials costs are largely driven by labor, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. It is ...
During your work as a CRA, you will do studies may involve the development of a new medication or assessment of a new medical device.A CRA is one of t...
Think about it, if no GMP!, Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have b...
Hi thuytienlecao Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QS...