ORGANIZATION PROFILE

Jubilant 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:
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Clinical Research
Bio-Analytics
Pharmacokinetics
Biostatistics
Quality Assurance.
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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. Biostatistics 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.