Edutech Worldwide 
iClinicR
India is fast becoming a preferred outsourcing destination for clinical research. A recent McKinsey Report predicts that the Indian Clinical Research industry will touch Rs. 5000 crores by 2010 and that India will need over 50,000 clinical research professionals. Presently the clinical research industry is facing a shortage of trained and qualified clinical research professionals.
To cater to this demand for trained clinical research professionals, Edutech and The Academy for Clinical Excellence have jointly developed an e-learning program on Clinical Research that aims to impart high quality training to entrants in the field and aspiring clinical research professionals, thereby enhancing the clinical research culture in India.
It is a web based certificate program consisting of CDs containing the audio visual lecture sessions, assignments, self evaluation quizzes and other teaching accessories. The curriculum of the program is designed and developed by eminent clinical research professionals from the pharmaceutical industry, contract research organizations and academia, and is intended to develop all round competencies in an individual taking this course.
The training modules created using best-in-class technology and content will facilitate easy and effective learning. The modules are developed to cover the various aspects of Clinical Research:
Introduction to Clinical Research
Definition, Types and Scope of Clinical Research, Good Clinical Practices, Drug Development Process, Careers in Clinical Research
Ethics in Clinical Research
Ethical Theories and Foundations, Ethics Review Committee and Informed Consent Process, Integrity & Misconduct in Clinical Research, Conflicts of Interest
Regulations in Clinical Research
Evolution and History of Regulations in Clinical Research, Patents, US Regulatory Structure, IND, NDA, ANDA, Post Drug Approval Activities, PMS, FDA Audits and Inspections, EU Regulatory Affairs, EMEA Organization and Function, Indian Regulatory system, Schedule Y- Rules and Regulations
Clinical Research Methodology
Designing of Protocol, CRF, e-CRF, IB, ICF, SOP, Pharmaco-epidemiology, BA/BE Studies, Report writing, Publication, CLINICAL RESEARCH MANAGEMENT, Preparation of a successful clinical study, Study management, Project management, Documentation, Monitoring, Audits and Inspections, Pharmacovigilance Training in clinical research, Budgeting in clinical research, Supplies and vendor management
Biostatistics and Data Management
Importance of Statistics in Clinical Research, Statistical considerations at the Design, Analysis and Reporting stage, Data management, Data validation, SAE reconciliation, Query management, Software considerations. Each of these modules comprise of audio visual lecture sessions, assignments, self evaluation quizzes and other training accessories. This ensures that the learning needs of the students / employees are effectively met at minimal cost.
- Online assessments leading to a ‘Diploma in Clinical Research'
- Learners can be based anywhere and take the course
- Learners can pace study according to their individual schedules
- Lectures by top industry professionals ensure high quality of learning content
- Offers the quality of classroom training program
- A diverse range of career pathways in: Pharma Companies, Clinical CRO, BA/BE centres, Data Management CROs, IT companies in Healthcare and many more
Prerequesite: Graduation in Life Sciences, Pharmacy, and Medicine with 55% aggregate marks
Course Duration: 6 months (can be extended upto a period of 1 year)
