Any medical trial or clinical research is incomplete without a clinical laboratory
. Traditionally speaking, a clinical laboratory examines and analyses components in blood, urine and body fluids. Blood grouping & Rh typing can also be performed. The Clinical lab has the capability to perform quantitative and qualitative analyses of urine, blood and other fluids as explained below:-
Qualitative Analysis is a test that is set up to identify the constituents of a substance or mixture. The question addressed is what is in it?
Quantitative Analysis is a test that is set up to understand the amounts or proportion of the substance or mixture used. The question addressed here is how many or how much is in it?
In the recent past, with medical activities gaining momentum in India, renowned CROs (clinical research organization) have specialized in innovative clinical laboratory services. This laboratory forms the foundation of medical studies and research. Accreditation by third parties - NABL and CAP assures high standards of quality and testing that are internationally acceptable.. The lab is well equipped with state-of-the-art infrastructure and impeccable logistics. The prominent part of a clinical laboratory is that it deploys highly experienced and trained personnel; Laboratory Information System is used for online information transfer and ensures short turnaround time with commendable levels of quality and consistency.
Clinical laboratory services include a wide range of investigations. They are:-
Hematology
Coagulation
Biochemistry
Serology & Immunology
Urine Analysis
Hormonal assays
Clinical laboratories owned by Indian CROs also help in conducting Phase I study by providing the necessary lab support.. The study includes the following aspects:-
First-in-human
Single Ascending Dose studies
Multiple Ascending Dose studies
New Chemical Entities
Dose Escalating studies
A clinical laboratory is the backbone of all experiments and drug developments. Hence it is essential to upgrade it from time to time with adequate resources.