Any Change or modification to the clinical protocol may be reported in a 5-day notice and they can be implemented if they do not affect:
a)validity of data or information resulting from the protocol
b)scientific soundness of the investigation plan
c)The rights,safety or welfare of the human subjects

And the changes that do not require any FDA…[Read more]

Many times the clinical trials conducted by the CRO are done with the intention of gaining maximum profit out of the business without any concern for the safety and efficacy of the patients. In my opinion, the outsourcing policy only benefits the organization by extracting the poor, illiterate and needed population by giving them lucrative offers.…[Read more]

It is difficult to exactly pinpoint the required rate of return due to the various estimates and preferences that differ from one decision maker to another.The various factors that determine the rate of return are the risk return preferences, inflation and the capital structure of the firm. Each of these factors greatly affect the intrinsic value…[Read more]

Fault Tree Analysis(FTA); which is used to give a graphical representation of the reliability of a system in order to predict the performance of its elements and identify any key poor performers that need further designing.And maintains the overall life cycle cost of keeping a system available.

Pros:
1. Allows a clear representation of the…[Read more]

In my opinion, if it is a small organization looking for outsourcing, then it should go for smaller vendors to cut down on the cost and to maintain flexibility rather than going for larger players as they may not provide that much attention to a smaller client. Secondly, if the requirement of the company is niche that can be met only by an…[Read more]

Photodynamic therapy with PHOTOFRIN is an example of combination device that comprises of two stages. In the first stage, an intravenous injection of PHOTOFRIN is given to the patient. It gets cleared from most of the tissues over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system that includes
liver and spleen retain…[Read more]

In my opinion, the project review meetings are vital for delivering the status of the project to executive management and other stakeholders, it provides them with the updates and the major milestones of the project, while addressing any emerging issue within the project. But one problem with these monthly meetings is that no matter how…[Read more]

In my opinion, completing the product life cycle is not that easy in real life.A bunch of people who are
experts in their fields and are working together to complete a project, will have to overcome many minor
issues with in the team to achieve the target. For instance, the PM might not be on the same page with the
the designer of the product and…[Read more]

Once the problem is identified by someone and it requires a change.The scope of the issue and its possible impact are estimated before generating an engineering change request (ECR) to examine the feasibility of the change that might include identification of parts, components,resources, estimation of the costs and change in documentation to…[Read more]

I do not have any personal experience with FDA audits. But i feel its always wise to adhere to the Good Clinical Practices(GCP) to stay on the safer side. Sticking to the proper Standard Operating Procedures(SOP) to maintain the consistency, or proper documentation of the data, receipts, subject consent forms and records keeps one in compliance…[Read more]

Every project requires the Monitoring and Controlling Process to review the progress and make changes in it to eliminate chances of future setbacks and to increase the workflow. And it comprises of set of skills and knowledge to implement the decisions required to maintain the active part of the project. Out of all the techniques to ensure the…[Read more]

Any project requires the Monitoring and Controlling Process to review the progress and make changes in it to eliminate chances of future setbacks and to increase the workflow. And it comprises of set of skills and knowledge to implement the decisions required to maintain the active part of the project. Out of all the techniques to ensure the…[Read more]

I agree with Robert, that the suppliers must be contacted in the Project Planning Phase as this is the phase where the PM has to make an educated guess of the staff, resources and equipment needed to complete the project. He needs to communicate and plan procurement activities, and make contracts for any 3rd party suppliers. In short, this is the…[Read more]

I would like to add to the above discussion that in any quality assurance, the corrective plan is vital to address any type of gaps in the quality controls or procedures. And in order to do that, the person responsible for the quality assurance must verify the source of the non- compliance as he is one who species the group with the responsibility…[Read more]

I would say this course is a must for anyone and everyone looking for career advancement in any field. It really helped me by giving an insight into the life of a PM and helped me understand better the roles and responsibilities of a PM and how important it is for a Project Manager to plan, manage, execute and deliver the projects thereby…[Read more]

I would say this course is a must for anyone and everyone looking for career advancement in any field. It really helped me by giving an insight into the life of a PM and helped me understand better the roles and responsibiities of a PM and how important it is for a Project Manager to plan, manage, execute and deliver the projects thereby…[Read more]

Any company seeking global presence, has to consider several key factors to handle an international project successfully such as:
1. Legal Systems
2. Quality Standards
4. Language Barriers
5. Time Zone Changes
6. Economic Conditions
7. Cultural differences.
If these factors are not taken into account by the PM while delivering an international…[Read more]

In any project, the milestones are the important landmarks to assess the project.The project manager uses milestones to gauge if the project is on the right track, whether it is ending the project phase or completing the deliverables. In order to avoid missing milestones, the project manager should use short and descriptive names such that the…[Read more]

In any project, the milestones are the important landmarks to assess the project.The project manager uses milestones to gauge if the project is on the right track, whether it is ending the project phase or completing the deliverables. In order to avoid missing milestones, the project manager should use short and descriptive names such that the…[Read more]