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 the study will take?, Are you able to find a CRO will give you a reasonable cost for the study?. Also, it is important to account for hidden costs…[Read more]

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 project goals on time and within budget, despite having fewer resources than large organizations.

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 implementing new processes to start a different division of the organization. Outsourcing uses the developed workforce of an outside organization to perform…[Read more]

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-qualification, the manufacturer can determine whether there have been any changes in equipment performance as a result of the move. Changes in equipment…[Read more]

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 actual treatment and perhaps another group that’ll receive a type of “sugar pill” or something else that won’t treat the illness or condition, but the pat…[Read more]

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 the real world problems in the industry. Very useful class for quality engineers, CRAs, and any one work in the industry.
I also recommend this class…[Read more]

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 opportunities to choose the best environment for your career goals. AS a CRA, you will be working with patients, physicians, and many other health…[Read more]

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’s scope in a way that everyone can understand. They must also be able to provide regular constructive feedback to the team.
The success of a p…[Read more]

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 company to do maintenance and installing for different medical imaging modalities equipment.

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 support or sustain human life; and is used for substantial importance in diagnosing, curing, mitigating, or treating disease. Examples of SR devices…[Read more]

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 more expensive than others to conduct clinical trials. For example, a clinical trial in India can cost one-tenth of the price that it would cost in the…[Read more]

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 opportunities to choose the best environment for your career goals. AS a CRA, you will be working with patients, physicians, medical writers and many other…[Read more]

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. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality product. This will improve the sales…[Read more]

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 audits. In QSR, the audits have two primary purposes: Assure that the quality system is in compliance with the established quality system requirements,…[Read more]

1)Who should do the communication on a project dependent on the organization set-up?

Communication in any project is an essential tool for a PM, also regardless of your role on the project, you must learn how to communicate effectively (with the project team members or with a client) to be successful. Communication is the key for success for…[Read more]

Adding to the discussion, systems approach to project management enables the project manager to constantly evaluate the needs of the customer and the end results that are needed to be achieved in terms of resources, budget and time. A successful approach to project evaluation must consider all elements of the system. The evaluation needs to be…[Read more]