Clinical tests and researches that are conducted in bio clinical laboratories have a crucial role to play in detection, diagnosis and the treatment of any ailment. Medical technicians and other professionals examine the cells, tissues and body fluids in these laboratories. In addition to that they also tally the blood for transfusions and test the levels of drug dose in the human blood thereby estimating how a certain patient is responding to the treatment. In addition to that, they also use automated devices, microscopes, cell counters and other new age laboratory equipments.

In the recent times, there are well known clinical research organizations (CRO) that specialize in clinical laboratory regulations as well as services. Ideally, these laboratories take part in various studies and medical researches that are certified by CAP and NABL. Simultaneously, there is state-of-the art medical architecture that offers unmatched logistics. A crucial aspect of the clinical laboratory is is trained and experienced professionals that are supported by new age devices which also includes the Laboratory Information Management System. This is used for online data transfer and it makes sure that there is a high level of service. This apart other clinical laboratory service includes the following:-

* Hematology
* Urine Analysis
* Coagulation Studies
* Biochemistry
* Clinical Pathology
* Endocrinology
* Serology
* Inflammatory/Immune markers
* Infectious Disease Markers
* Therapeutic Drug Monitoring
* Tumor Markers
* Lipid Profile
* Liver Function Test
* Anemia Profile
* Renal Profile
* Diabetic Profile
* Biomarkers
* Capabilities for other tests

With regards to clinical laboratory regulations compliance services and quality assurance is an important aspect. The CRO's have their own team of audit compliance and regulatory services that are in turn supported by a huge knowledge pool on regulatory processes and new age liaison with multiple regulatory agencies that offers effective clinical trial approval process. The wide selection of regulatory compliance services includes the following:-

* 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

The main objective of clinical laboratory regulations and compliance is to keep the medical processes in a certain order and to ensure the efficiency of clinical trial programs.

Today prominent CRO's (clinical research organizations) in India provides a comprehensive range of data management services in Biometrics and Phase I to IV clinical trials. Their core objective is to convert raw data into accurate and reliable trial outputs in compliance with the regulatory guidelines. The CRO's have a dedicated Biometrics team to focus on speeding up the regulatory submission process and then minimize the timelines with high-end services and advanced thinking.