Embark on a journey of innovation and discovery in healthcare with Bezel Institute’s Advanced Diploma in Clinical Research. This program offers a comprehensive understanding of the principles and practices of clinical research, preparing students for rewarding careers in this dynamic field.

Program Overview
The Advanced Diploma in Clinical Research is a rigorous program spanning over 3 months and designed to equip students with the knowledge and skills needed to excel in clinical research roles. Throughout the program, students will delve into various aspects of clinical research, including study design, data collection and analysis, regulatory compliance, and ethical considerations.

Career Benefits in Clinical Research

Graduates of the Advanced Diploma in Clinical Research are well-positioned for a variety of career opportunities in the healthcare industry. Some of the key career benefits include:
– Opportunities to work in pharmaceutical companies, contract research organizations (CROs), academic research institutions, and government agencies.
– Lucrative salary packages and career advancement opportunities.
– Contribution to the development of new medical treatments and therapies.
– Job stability and high demand for skilled clinical research professionals.

Potential Employment in Indian Companies and Hospitals

In India, there is a growing demand for skilled clinical research professionals, especially in metro cities like Delhi, Mumbai, Chennai, Bengaluru, and Hyderabad. Graduates of the Advanced Diploma in Clinical Research can explore employment opportunities in:
– Pharmaceutical companies: Conducting clinical trials to evaluate the safety and efficacy of new drugs.
– Contract research organizations (CROs): Providing research services to pharmaceutical companies and other healthcare organizations.
– Hospitals and research institutions: Participating in clinical research studies and managing research projects.

Program Duration and Curriculum

Duration: 6 months

MODULE 1

1. OUTLINE OF CLINICAL RESEARCH

• Introduction to Clinical Research
• Phases of Clinical Trials
• Clinical Study and Clinical Research
• FDA Product Regulation
• Inclusion of Study Participants

2. CONDUCTION OF CLINICAL STUDIES AND OBSERVATIONAL STUDIES

• Treatment trials
• Prevention trials
• Diagnostic trials
• Screening trials
• Quality of Life trials

MODULE 2

EDC System , PROTCOL TEMPLATE , BUDGET TEMPLATE

• Clinical Study Design
• Sample size and Power
• Randomization
• Developing Protocols and Manuals for Operating Procedure
• Developing Protocol Budget ( Protocol /Budget Template)

MODULE 3

CLINICAL DATA MANAGEMENT

• Introduction to Clinical Data Management
• Data Management
• Data Collection and Case Report Form Development
• Entering Data
• Clinical Data Interchange Standards Consortium (CDISC)

MODULE 4

REGULATORY AFFAIRS

• Introduction to Regulatory Affairs
• Adverse Events Reporting
• Institutional Review Boards
• Mock IRB
• Data and Safety Monitoring Committees

MODULE 5

MEDICAL WRITING

• Introduction to Medical Writing
• Introduction to Medical Terminology
• Medical Terminology : Abbreviations , Symbols and Special Terms
• Documenting Medical Records
• Diagnostics Coding

MODULE 6

PHARMACOVIGILANCE

• Introduction and Origin of Pharmacovigilance
• Pharmacovigilance terminologies and Process flow : Safety Reports
• Types of Pharmacovigilance
• Carrier Opportunities in Pharmacovigilance
• Pharmacovigilance Programme in India

Additional Details

– Faculty: Learn from experienced industry professionals and academic experts who bring real-world insights to the classroom.
– Internship Opportunities: Gain hands-on experience through internships at leading pharmaceutical companies, CROs, or research institutions.
– Industry Certification: Prepare for industry-recognized certifications such as the Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).

Join us at Bezel Institute of Healthcare Studies and take the first step towards a successful career in clinical research. Unlock your potential and make a difference in the future of healthcare.