Overview

India is fast emerging as a favorable destination for conducting global clinical trials. The availability of highly qualified medical practitioners, lower drug development cost, wide spectrum of disease and skilled manpower proficient in English language is attracting conduct of global clinical trials in Indian hospitals and clinical sites. Since India has implemented GCP as per ICH global standards, it is now possible that the data from conduct of trials in India as per GCP guidelines maybe submitted for approval of the
drug in USA, Europe, Japan, etc along with submission to authorities in India. The clinical trial industry is doubling in revenue every 2 years and as per Mckinsey estimate India has the potential to become one billion dollar revenue industry.

Current outsourced clinical trial activity in India is at around Rs. 3.5 billion (about US $ 75 million) and is estimated to go up to Rs.13 billion (about US $ 281 million) by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. That’s not all. Trained Clinical Research professionals will also be in demand abroad. There are more than 2,50,000 positions vacant worldwide and salaries in the U.S. vary in the region of approximately USD 40,000 p.a. for a Clinical Research Co-ordinator to almost USD 100,000 p.a. for a Business Development Manager. Rest assured, Clinical Research is definitely the next big career and now is the time to make it a vocation. With demand far outstripping supply, it seems to be a win-win situation for the clinical research associates.

Course Details

Course Objectives

• Obtain a clear understanding of Good Clinical Practice and Standard Operating Procedure for Clinical Research andClinical Data Management.
  
  
• Provide Individuals / Students / Professionals from Pharmacy, Medical, Nursing, Life Sciences, Research & Development, Clinical Research, Allied areas and Academic fields, a basic to advanced level understanding of various clinical trial processes.
  
  
• Enable participation in design, conduct and management of global clinical trials, conducted at multi-centric sites in India and overseas.
  
  
• Acquire an understanding of evolving regulatory processes, standards and practices of ICH GCP in the conduct of different therapeutic trials and in the preparation of submissions to be made to regulatory authorities in India and overseas.
  
  
• Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC) system and Project Monitoring.

Course Content

Module-1

• A Historical Perspective on Clinical Research
• Clinical Epidemiology
  • Evidence based medicine
• Clinical Research
  • Introduction to Clinical Trials
  • Clinical Trial Protocol
  • Meta Analysis
  • Quasi Experimental Technique

Module-2

• Good Clinical Practices (GCP
• Laws Governing Clinical Research
• Ethical Principles in Clinical Research

Module-3

• Informed Consent in Clinical Research
• Clinical Data Management
• Clinical Research Budgeting

Module-4

• Clinical Research Audit and Inspection
• Clinical Research Frauds
• Statistics for Clinical Research
  • Data, Central tendency and Variation
  • Differences between percentages and paired alternatives
  • The t tests
  • The chi-squared tests
  • Exact probability test
  • Rank Score tests
  • Correlation and regression
  • Survival analysis
  • Study design and choosing a statistical test
• Clinical Research Glossary
  

Career Prospects/Benefits

1. Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization).
   
   
2. Jobs are also available in pharmaceutical industry, drug development, medical writing, and biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs and Auditing of Clinical Trials.
   
   
3. 2,50,000 vacancies available worldwide.
   
   
4. 50,000 job openings in India by 2010*.
   

* McKinsey Report

Course Fee

Rs.30,000 in single instalment or 2 equal instalments of Rs. 16,000 each in favour of "Medvarsity Online Limited" payable at Hyderabad. Fee includes Boarding and Lodging in and around Apollo Campus during contact program.*

Duration & Contact Program :

6 months Online study includes1 week contact program at Apollo Hospitals,Hyderabad.

Eligibility Criteria

Graduates in Life Sciences, Pharmacy, Allopathic Medicine, Homeopathy, Ayurveda, Unani, Dentistry,Paramedical Sciences, Physiotherapy, Allied Health Sciences and Biotechnology.

Course Delivery

Online Study along with CD and printed study material.

Evaluation & Certification

The course is divided into 4 study modules each having an assessment. All these assessments are online and objective.
It is mandatory to obtain a minimum of 50% marks to clear an evaluation.

The candidate is required to complete all internal assessment tests and the contact program. Final examination will be conducted online at the end of the course. Successful candidates will be awarded Certificate by AHERF. * conditions apply.

About Medvarsity

Medvarsity, India's first virtual medical educational portal was established in April 2000 as a joint venture by Apollo Hospitals & NIIT. Medvarsity in association with Apollo Hospitals conducts online courses for medical & paramedical community. Medvarsity offers its courses in collaboration with reputed bodies like Royal College of General Practitioners and Apollo Hospitals Educational and Research Foundation, IRDA Etc.

About AHERF

Apollo Hospital Educational and Research Foundation conducts other educational and training programs including Nursing, Physiotherapy, Emergency Medicine, Surgery, Anesthesiology and Masters Degree in Hospital Administration.

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