Clinical Laboratory and Their Role in Drug Development
Medical tests and researches that are performed in clinical laboratories play an important role in diagnosis, detection and treatment of any disease. Technologists practicing here are called medical technologists or clinical laboratory scientists. They examine tissues, cells, and body fluids. Furthermore, they match blood for transfusions and also test the drug levels in blood analyzing how a particular patient is responding to a treatment. They make use of the automated instruments and equipments, cell counters, microscopes and other modern laboratory devices. Recently, with the increase of medical activities in India, there are eminent CRO’s specializing in innovative clinical laboratory services. Such a laboratory is the core of numerous studies and research activities that are approved by NABL and CAP. The laboratory houses testing program along with international and national labs for maintaining quality control. Furthermore, it is equipped with state-of-the-art infrastructure, modern day medical devices as well as impeccable logistics. The most import aspect of a clinical laboratory is that they have highly experienced and trained personnel, who are in turn backed up by age technological devices as their aid comprising the latest Laboratory Information Management System. This is meant for any online information transfer and it ensures less turnaround time with commendable levels of quality and consistency. Apart from helping in clinical trials, there are few other clinical laboratory services centers around a wide range of investigations. They are:- * Hematology * Biochemistry * Serology * Urine Analysis * Capabilities for other tests Regulatory compliance services & QA too forms an essential part of eminent CRO offering clinical laboratory services. There is a dedicated group for audit compliance and regulatory services that is assisted by a vast knowledge pool on regulatory processes and innovative liaison with numerous regulatory agencies that ensure efficient in medical trial approval processes. The wide range of regulatory services provided are as follows:- * Formulation of regulatory strategies * Compilation of the clinical trial application * Submission and follow-up of the application * Response to regulatory agency queries * Procurement of drug import licenses * Procurement of NOC for export of biological samples * Tracking of applications and approvals * Safety Reporting * Submission of Clinical Safety Report (CSR) * Renewal of Import License Research and studies, such as Phase I studies too are also an area in which clinical laboratories play an important part. These studies promote better treatment and drug development to the chronic diseases and other abnormalities. Click here for more on phase i studies