Ventura Institute of Bio Sciences
 
 
Biotechnology - Training - Ventura Institute of Bio Sciences
 
 
DEPARTMENT OF CLINICAL RESEARCH
 

Ventura Institute of Bio-sciences ,ISO-9001-2000 certified Institute , offers training in Clinical Trial course.The industry is looking for science graduates from pharmacy, medicine, life science and bioscience.. Anybody who fulfils these criteria can join the industry. This Course is desined to fullfill the needs of industry and to enhance the knowledge in Clinical Trial,Research & Administration. A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or contract research organizations (CRO's) on their behalf. It is this sector that is driving the growth in clinical research in India. There will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. Clinical research is all set to become the next big thing in India. A large population with a substantial workforce and cost benefits influence multinationals to set up research facilities here. Besides due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry.

  Experts
 

According to MCKinsey report by 2010 more than 50000 professionals will be required in the field clinical research India alone. There is no doubt that the cost of doing clinical trials in the U.S. is absolutely proohibilitive, and we can save substantially – I mean hundred of millions of dollars of pure savings – by switching some of the trials to other , lower – cost countries” Glaxo Smithkline Former CEO Jean Pierre Garnier to Business Week Over 100 pharmaceutical companies, including Fortune 100 companies such as pfizer and Merck, are currently outsourcing clinical trials in INDIA, India’s inherent advantage in IT skills helped in outsourcing of high end activities like data management.. CYGNUS Currently, most local and global CROs consider an operational presence in India as key to their overall business plans, Farz kermani, ph. D., is a clinical trials consultant at Bio Plan Associates, Inc Basically, we would be glad to provide technical assistance to the Indian government Andrew Von Eschenbach and US Health and Human Service (HHS) Secretary Michael Leavitt. India is turning out to be one of the hottest destinations for conducting global clinical research, owning to a huge patient pool, easy recruitment of patients, and high cost saving, Business Daily from THE HINDU group of publications. A recent global study conducted by consulting firm AT Keaney says that India is the second most preferred destination for outsourcing of clinical trials for the pharma industry. THE ECONOMIC TIMES.

 
       
  Module Duration
» Program in Clinical Research 45 days Click for more details
» Clinical Data management 45 days Click for more details
  Course Objective:
  This course aims to provide students with theoretical and practical under standing of issues involved in clinical trial process, conducting, monitoring, Reporting ,Management and Guidelines
Program in Clinical Research
Duration - 45 days

MODULE:

  1. Drug Development Process
  1. Good Clinical Practise and Regulations    
  1. Informed Consent Process
  1. Adverse Event
  1. Study Activities
  1. Study documents
  1. Study Drug Management

  2. Case Report Form

  3. Indian Regulations

  4. Data Management

  5. Pharmacovigilance and Quality Control

  6. Roles & Responsibilities

 

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Clinical Data Management
Duration - 45 Days

MODULE:

  1. Intorduction to Databases
  1. Study Management

  1. Clinical Trail Process

  1. Regulatory Affairs

  1. Trial Design

  1. Data collection

  1. Data Entry

  1. CRF Design

  1. Safety Reporting and management

  1. SOP

  2. Data Validation and Cleaning

  3. DATA Forms Mangement

  4. Open Clinica Data Base( Comprehensive)

  5. ORACLE Clinical And Rave ( Over View)

 

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   Placement Assistance:

 

100% placement assistance will be provided to students who have 80% attendance in the program and above 65% marks in the exam Conducted By Department of clinical Research

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   Career:

 

Pharmaceuticals Companies

Clinical CROs (Contract Research Organizations

BA/BE Centers

SMCOs (Site Management Organizations)

AROs (Academic Research Organizations)

Data Management CROs

IT Companies in Health Care / Clinical Domain

EDC Service Providers

Central Laboratories

Packaging & Labeling & Contract Manufacturers

Investigator & Site Staff

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    Career Profile

 

Clinical research co-ordinator

Clinical Research Associate

Monitor

Data Base Associate

Medical writer

Manager

Data base Manager

Data Base programmers

 
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Ventura Institute of Bio Sciences
 
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