Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. It is important to consider the experience of CRO in that particular area and important to consider the financial stability of CRO. Appropriate CRO infrastructure is essential to support your project requirements, Ask what software t…[Read more]

FDA and manufacturer monitors the products in the market whenever the manufacturer founds any product defective or potential harmful they would recall it or sometime FDA recalled the product after customer complaints. There can be number of reasons like health hazard,poorly packed or labeled. Recall effects the business badly ,it often tarnishes…[Read more]

I would like to be a statistician . Clinical projects usually collects a lots of data so the statistician summarize the data so that non statistician can understand. A Statistician helps to optimize design, analysis, interpretation of results and conclusion. Statisticians help ensure that experiments are designed, run and analyzed in the best way…[Read more]

When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol’ study flow chart .other costs should be considered like cost related with shipping. Always take into account the hidden costs like time and cost related to CRF completion or reporting…[Read more]

When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol’ study flow chart .other costs should be considered like cost related with shipping. Always take into account the hidden costs like time and cost related to CRF completion or reporting…[Read more]

The project manager for medical device company leads the team of engineer ,owns the relationship with clients and applying engineering knowledge to ensure successful outcomes . Assembling a medication reconciliation team is an important task for project manager for medical device company . The Design Team should be comprised of multidisciplinary…[Read more]

The Non-Conformance Material Report is used to report and disposition non-conforming material identified during inspection (Quality or Warehouse Inspection) or during the movement of the materials and/or when the material is in stock. The material is inspected to verify that the items conform to the relevant specifications and/or drawings. During…[Read more]

Contract negotiation should be based on the uncertainty of scope, assignment of risks, need for predictable costs and importance of meeting milestones dates. Contract should be fair ,reasonable , and beneficial to both parties not depends upon the smart party. While negotiating for contract payment terms, contract volume, work dates, price,…[Read more]

Six Sigma uses statistical and numeric methods to reduce the number of defects in output to an insignificant level. It focus on understanding customer’s requirement better and eliminating waste and defects. The objectives is to improve the organization’s products, services, processes across production marketing and finance. The method integrates…[Read more]

The QA and QC both are the part of Quality Management system .QMS takes comprehensive approach affecting the company’s processes ensuring the safety and efficiency. QA is process oriented or procedure oriented as it focused on methods how to prevent the defects in the process while QC focus on the identification of the defects hence it is product…[Read more]

SV and CV are two essential parameter in earned value management and helps to analyze the project. If both are positive means project is progressing well but if one of the variance is negative then some corrective action are needed to bring the project back on track. I would prefer the project with CV positive and SV negative because this means…[Read more]