Docstoc

Features Of Clinical Research Organizations

Document Sample
Features Of Clinical Research Organizations Powered By Docstoc
					                          Features Of Clinical Research Organizations

Most often a clinical research organization (CRO), is termed as a contract research organization. Simply
put, it is a service organization that provides help to the pharmaceutical and biotechnological sector in
the process of drug development through non-clinical and clinical trials.


With the increase of medical tourism in India, leading clinical research organizations have set up in the
country. These CRO’s are proactively involved in Clinical trials in patients, special population studies
accompany by medical volunteers. In India, the renowned and leading CRO’s are located in the southern
part that includes places like Bangalore and Chennai. Amidst their wide portfolio of services there is
advanced Phase I to III studies with biotechnology companies. Furthermore, the CRO’s have created a
positive name for their extensive service portfolio and expertise in areas such as:


    ●   Bio Studies
    ●   Bioanalytical Research
    ●   Biometrics
    ●   Medical Writing
    ●   Regulatory Services


This apart, the CRO’s have a specialized department for QA and regulatory services that constitute
an important part of their service portfolio. A dedicated team is allocated for the same that conducts
audits and are supported by in-depth local regulatory procedures and effective coalitions with various
regulatory agencies. Some of the essential services that are offered includes:


    ●   Formulating regulatory strategies
    ●   Compiling a clinical trial application
    ●   Follow up and submission of the application to DCGI
    ●   Being responsive to regulatory agency queries
    ●   Procuring drug import licenses
    ●   Procuring NOC for export of biological samples
    ●   Tracking of approvals and applications
    ●   Safety Reporting
    ●   Submission of Clinical Safety Report
    ●   Renewal of Import License


Keeping in mind the present day chronic ailments CRO’s also conduct medical studies such as the Phase
I study and other medical researchers in their bio clinical laboratories. These laboratories are equipped
with state-of-the-art infrastructure that helps in drug development processes and other treatments.
Important components here are:


    ●   Single Ascending Dose studies
    ●   Multiple Ascending Dose studies
    ●   New Chemical Entities
    ●   Dose Escalating studies
    ●   Capabilities


Therefore CRO’s provides advanced services for Phase 1 studies for instance First-in-Man for new
chemical entities (NCEs) as well as new biological entities (NBEs). Simultaneously, they also offer
services for a suite of clinical pharmacology studies that comprises of Food Effect, Drug Interaction
studies, Pharmacokinetic / Pharmacodynamic studies Proof of Mechanism & Proof of Concept, TQTc
studies, exploratory studies for special Population studies and multiple biomarkers.


Read More On: Clinical Pharmacokinetic, biometrics companies

				
DOCUMENT INFO
Description: Most often a clinical research organization (CRO), is termed as a contract research organization.