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  What is the secret of high quality service? There are a few important points that counts a lot, like SOP specifications of the company, personnel training and their assessment, protocol based management system, real time monitoring, periodic review and incorporation of the test data into the clinical trial etc. We believe employing these factors into the clinical trial to the extent it is possible will bring about the quality result.

To make it clearer, let’s take an example of the study involving the cancer drug. The study involves the withdrawal of the subjects who are not suitable to continue the trial due to some medical reasons. It ultimately affects us, who are in the project plan task. Analysis of these data collected during the clinical trial is done by the department of the biometrics, and it is not necessary the data analysis is done at same point of the time for all study, as it solely depends upon the characteristic features of the trial. And in some cases, like the clinical trial of the cancer drug, data from a large number of subjects are excluded. This analysis is eventually reported to the department of the clinical operation and the department of the medicine. Together with the research project team, effectiveness of the data and safety of the drug is reported. 

●  Each clinical study project is associated with some risks and a good project team reduces the risk by utilizing the standard regulations, GCP and interrelationship of different kinds of record. We ensure the project is at low risk state by maintaining good and well-timed communication with the researchers and the sponsor.
●  Scheduling the research progress plan, ensuring the quality of the site, being aware about the actions promoting the research progress and understanding the relationship among these factors aids the risk management.
●  We cooperate the researchers to produce high quality report and keep our sponsors informed about their interest and the research progress.
●  Based on the project type and the emphasis laid by the sponsor (such as market approval, registration, BE study etc.), resources are utilized in the key focus area to meet the objectives of the sponsor.
●  Professional standard management, cost control and avoiding repetition of the procedure or the part of the procedure.     

For a good quality service, CRO should be able to integrate the quality control requirements efficiently and ensure the entire quality control system for the professional management, like
●  For any professional field study, professional experts of that particular field should provide the opinions and judgments that will match the project plan of the sponsor and the product development requirements.
●  Should be able to assess the concordance of the resources and provide the quick advice to the sponsor
●  Should allow the sponsor to observe the project implementation process and its efficiency including the result of the quality control protocols.

I consider following few aspects to be very important in maintaining good quality control of a clinical research project
●  The project team should have strong knowledge of GCP and it should be brought into the practice very strictly. It is therefore, CRO should organize regular training, personnel assessment and a variety of experience sharing programs.
●  Project risk analysis at every level of the research study，being prepared for any adverse event that can occur during the research study, formulating corresponding measures to ensure the project is being conducted in accordance with the timetable.
●  Periodic quality check can be carried out by co-monitoring, arranging QC visit, arranging audit to find all kinds of problem. After the problem is identified, it is equally important to deal with it in a proper manner, for e.g. combining the quality check results with CAPA system.
●  Documentation and periodic audit of research data also play an important role in the quality management system. Department of biometrics and medicine should regularly review the data and carry out the analysis of these data for PD and AE events. In addition to it, sponsor should regularly participate in the meeting to discuss the case of PD, AE and so on.