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The simple way to define the bio clinical laboratories is that they are medical laboratories where tests are conducted on clinical samples for attaining information on the patient’s health with regards to the treatment, diagnosis and disease prevention.

Bio clinical laboratories generally participate in certain testing programs with national as well as international labs in order to retain high level of quality control. They are well equipped with state-of-the-art infrastructure, innovative devices and accurate logistics. This apart, there have highly trained medical professionals that are supported by the latest technology that also includes the Information Management System used for transferring online data and assures lesser turnaround time with exceptional levels of quality and reliability.

A bio clinical laboratory is completely geared for conducting a wide range of investigations that comprise the following:-

* Hematology

* Biochemistry

* Serology

* Urine Analysis

* Capabilities for other tests

Bio clinical laboratories also support the Phase 1 Studies that are in turn backed up by the medical trails and consists of the following components :-

* First-in-human

* Single Ascending Dose studies

* Multiple Ascending Dose studies

* New Chemical Entities

* Dose Escalating studies

Eminent bio clinical laboratories in India today provides specialized services for Phase 1 studies for instance the First-in-Man for new biological entities (NBEs) and the new chemical entities (NCEs). Along with that they also provide services for a suite of clinical pharmacology studies that consists of components such as Proof of Mechanism & Proof of Concept, Food Effect, Drug Interaction studies, TQTc studies, Pharmacokinetic / Pharmacodynamic studies, and other exploratory studies for numerous biomarkers.

In addition to that these high-end laboratories comprise of effective regulatory services that has successfully completed numerous audits from Indian as well as International regulatory agencies. The wide range of regulatory services that are on offer are listed below:-

* 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

Hence, from drug development, disease treatment to medical studies and researches a bio clinical library is the back bone of the CRO’s with its unique service offerings and the new age medical assistance.