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Some Essential Yet Unknown Features of Clinical Research Organizations

Posted Dec 14 2012 9:49am

Are you looking for your career in clinical research organizations? How much do you know about it? Are you aware of all its aspects and features? Well here is something which will prove to be a guide for all the interested candidates who aspire making their career with CRO. Very often clinical research organization is also known as contract research organization. Simply called it is a service association which offers help to biotechnology and pharmaceutical sector in the procedure of drug development by means of clinical trials and non-clinical trials.

Clinical Research Organizations

With increase in the figure of medical tourism in every nation, leading clinical researchorganizations have been set up. Such CROs are now proactively engaged in clinical trials on patients, particular population studies which is accompanied by medical volunteers. While all nations have number of well established CROs, in India some of the leading and renowned CROs are located in southern region which includes places like Chennai and Bangalore. Amidst their extensive portfolio of services, there is incredible advanced Phase 1 to Phase 3 studies with number of biotechnology firms. Also the CROs have developed an optimistic name for their comprehensive service portfolio in some particular areas like:

·         Regulatory Services

·        Bio Studies

·        Medical Writing

·        Biometrics

·        Bio-analytical Research

Apart from this, the CROs have a special department for regulatory services and QA which form a significant part of their comprehensive service portfolio. A committed team is allocated for this which performs the audits. Such team is supported by profound local regulatory processes and efficient coalitions with number of regulatory agencies. Some of the basic and primary services offered by these CROs include:

·         Compiling a clinical trial application

·        Formulating regulatory strategies

·        Being answerable to the regulatory agency queries

·        Follow up and compliance of the application to DCGI

·        Procuring the NOC for exporting the biological samples

·        Procuring the drug import licenses

·        Safety reporting

·        Tracking the applications and approvals

·        Renewal of import license

·        Submitting the clinical safety report

Keeping in mind now days chronic ailments, CROs have started conducting medical studies like Phase 1 and many other medical researchers in their well equipped bio clinical laboratories. These labs are equipped with advanced infrastructure which helps in the drug development procedures and many other treatments. Significant components here are:

·         Multiple Ascending dose studies

·        Single Ascending dose studies

·        Capabilities

·        Dose escalating studies

·        New chemical entities

Henceforth each clinical research organization offers superior series for Phase 1 studies like First-in-Man for innovative and New Biological Entities and New Chemical Entities. There is no dearth of career opportunities with CROs as they have number of job opportunities for number of services that they offer and number of departments that they have maintained. So if you are looking forward to climb the success chart in your life, make your career with one the best CRO and be ensured of a safe and secure future.
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