Volume :

3

Issue :

1

Abstract :

Clinical trials may be defined as biomedical or health related research studies in human beings that follow a pre-defined protocol. Clinical trials are the link between the results of preclinical testing and actual clinical practice. They are conducted to collect the data necessary to provide information for academia, industry and regulators and it is only through trials that progress is made on new medicines including drugs, vaccines, and devices, as well as improved treatments for diseases. Clinical trials involves interplay between clinical investigators (often referred as Principal Investigator or PI), patients, sponsors, control research organization (CRO), clinical laboratories with the overall objective of improving healthcare to ensure subject safety, validity, accuracy and credibility of data generated. To ensure that these concerns are adequately addressed in a study, regulations and guidelines have been developed like following the protocol, complying with regulatory and Good Clinical Practice (GCP) standards, collecting and reporting quality data and overall monitoring of the progress of trial. Maintaining accuracy and quality throughout the clinical study is a continuous dynamic process. There is increasing focus on having quality system in place throughout the planning stages of clinical trials with specific standards for each clinical trial process to produce a more reliable and useful end product – high quality data without compromising the rights and welfare of human subjects. Globalization, outsourcing and increasing complexity of clinical trials have made the target of achieving global quality challenging. Although the study requirements are carefully set forth initially, expectation and requirements can change during a study and coordination and harmonization throughout the trial is essential.