ORGANIZATION PROFILEJubilant Organosys Ltd. (Jubilant) is an integrated pharmaceuticals company. This is the first ever acquisition of a U.S. CRO by an Indian company, and it represent a major initiative supporting Jubilants plan to expand its CRO services globally. This acquisition makes Jubilant the largest Indian CRO having operations in India and USA. Jubilant has three subsidiary companies in India namely: Jubilant Biosys Ltd- for bio/chemo Informatics databases for drug discovery companies.

Jubilant Chemsys Ltd- for medical chemistry.

Jubilant Clinsys clinical research Ltd- for clinical research.

Clinsys clinical research Ltd (CCRL, Noida)Clinsys clinical research Ltd. conducts Bioavailability studies through its World-class facilities and Bioanalytical laboratory. It offers Bioavailability, Bioequivalence, Pharmakokinetic and Phase IInd & IIIrd studies as per ICH-GCP and USFDA guidelines. Clinsys aims to be the best clinical and Bioanalytical service provider to serve the global generic and NCE pharmaceutical companies in their endeavor for excellence and cost effectiveness.

Target is now able to offer its clients all of the benefits of providing clinical research services out of India, including high quality, cost competitive data management services and access to enlarge patient population of diversified ethnicity. This is enable faster patient enrollment, thus reducing the time taken to complete clinical studies. This is also allow clients to accelerate the process of obtaining marketing authorization for their new drug, resulting in faster realization of revenues from their investments.

Duration of my training was from 25 Mar to 25 Sep 2009.It was carried out in Jubilant Clinsys clinical research Ltd. Noida. The emphasis of the training was on the analytical aspects of Bio-availability/Bio-equivalence study of drugs using advanced instrumental techniques such as HPLC, LC-MS/MS.

The training was mainly carried out in Bio-Analytical division.

Jubilant Clinsys Ltd. Provides clinical research for evaluation of potential pharmaceutical products. A team of highly trained professionals from various disciplines manages it:

1. Clinical Research

2. Bio-Analytics

3. Pharmacokinetics

4. Biostatistics

5. Quality Assurance.

Clinical Research

A highly qualified clinical research team provides solutions and services to the clients across the globe. Clinical research team conducts Bio-Availability/Bio-Equivalence studies.

Bio-analysis

The Bio-Analytical team serves the pharmaceutical industry, by combining advanced analytical instrumentation with superior technical expertise. They develop, validate and perform analysis using Liquid chromatography with various spectrometric techniques, in support of clinical studies. They are dedicated to meet the highest standards of personal services and timeliness for every client.Pharmacokinetics

Pharmacokinetics is basically a part of pharmacology which mainly deals with the determination of quantitative study of absorption ,metabolism , and elimination of drugs from the body.

Biostatistics

It is the science of statistics applied to the analysis of biological or medical data. Bio-statistics is applied to a wide range of topics in biology. It has particular applications to medicine and agriculture.

Quality Assurance

The independent quality assurance team ensures that studies are conducted as per SOP following the protocol. It also ensures that GLP is followed at all stages through:

a) In Process, Retrospective and Systems audit.

b) Evaluation of SOPs protocols and project reports.

c) Documentation control.

Training of staff in compliance to GCP, GLP and regulatory requirements.

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