Why Monitoring

Why Monitoring

 

Study monitoring is an Integral Component of study quality assurance process and critical for GCP fulfilment and by selecting Cliniserve as monitoring partner we can save Sponsor's valuable time, travelling & accomodation cost. As we are local based we ensure to give more time fo monitoring.

 

Purpose :

 

     The purposes of trial monitoring are to verify that:

 

(a) The rights and well-being of human subjects are protected.

 

(b) The reported trial data are accurate, complete, and verifiable from source documents.

 

(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

 

For ethical reasons it is desirable to ensure that for human volunteers participating in clinical studies safety monitoring must be done periodically. It is also important to ensure that a study continues in adherence to protocol and standard operating procedures.

 

Adequate Monitoring of Clinical study is essential in assuring safe subjects, quality data and a well-executed study. For each phase of clinical/bioanalytical monitoring, Cliniserve will provide to the client a complete, detailed monitoring visit report after each clinical/bioanalytical monitoring visit within timelines.