We provides scientific solution that helps meet this challenge through the rich experience and versatility of directors in conduct of BA/BE studies. Our audits and solutions will be integrated to deliver to the sponsor the data which is generated with integrity and also ensures the sponsor regulatory compliance and approval.
The purpose of monitoring a trial is to ensure that the trial data is accurate complete and verifiable in accordance with ethical and scientific norms.
We will ensure that the rights and well being of subjects are protected and the conduct of the trial is in accordance to the trial protocol, GCP,GLP and other various domestic and international regulations.
Monitoring the Bioanalytical phase of BA/BE project right from verifying the accuracy ,precision, ruggedness and reproducibility of the Bioanalytical method.
Bioanalytical monitoring and review will include :