When preparing a budget for a clinical trial you need to perform an internal cost analysis by evaluating your study specifications and determining expected enrollment. You need to determine how long t...

Resources, budget,responsibilities and skills are main factors to determine how to manage a project in a small or a large company. Effective project management in a small business means reaching the p...

Deciding on when to outsource clinical trial or insource depending on the project, capabilities and resources needed. I think insourcing is more expensive for an organization as a result of implementi...

When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the re-qualif...

Hi all, Congratulations! We have completed MDD & AMDD. I found an interesting topic we should discuss or at least we should have idea about it, "Cost and Time of Device Clearance/Approval". How mu...

Example: Placebos Study Placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’ll receive the drug or device in question for actua...

Actually AMDD very useful class. I learned a lot about the regulations and QSR in US and regulations in EU as well. Participation & Simulations great features for the class. This class took me to ...

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 one of the clinical science jobs that offers many...

Motivation for a project manger is the key for success also Communication is another important key for a project manager. Project managers must communicate their visions clearly and project a project’...

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 can start my own company. My goal to start my own 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 intended to be used as an implant and; purported to supp...

clinical trials costs are largely driven by labor, much of these savings are from lower salaries to physicians, nurses, and trial coordinators. It is true that some regions of the globe are vastly mor...

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 the clinical science jobs that offers many opportun...

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 been made than preventing them in the first place. ...

Hi thuytienlecao Internal audits could be done by the manufacturer itself or by hiring auditor.Both 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485:2003 require internal quality au...