Clinical Research Certification Training Program

Duration: 2.5 Months

Clinical Research
Clinical Research refers to a study conducted to evaluate a potential
treatment and its effects on human beings. Clinical trials help us find out if a
promising new treatment is safe and effective. During a trial, more and more
information is gained about a new treatment, its risks and how well it may not work.

Program Summary

Certification in clinical research (CCR) is designed to provide candidates

with an opportunity to acquire and develop the expertise necessary for effective
clinical research. The program is designed to meet the high demand for trained
personnel for human clinical trials.
The program enable you to master practical aspects of clinical trial conduct and
management including clinical trial phases and design, planning, implementation,
data analysis, regulatory and procedural guidelines and ethical considerations.

Course Fee
Rs. 24,000/- +GST including study material.

Eligibility
Minimum 18 years of age and high school completion or its equivalent with
life sciences background. Students need competency in, or completion of a basic
computer operations course. Student will be required to have access to the
internet, printing capabilities and email address.

Program Outline
 Introduction To Clinical Research
 Basic Pharmacology & Pharmacy in CR
 New Drug Development
 Guidelines For Clinical Trials (ICH – GCP)
 Ethics in Clinical Research
 Regulations in Clinical Research
 Biostats & Clinical Trial Designs
 Clinical Trial Documents
 Quality in Clinical Trials
 Clinical Trial Management -Project Management
 Drug Safety & Pharmacovigilance
 Clinical Data Management

Program Objectives
 Learn the process of drug development
 Gain an understanding of the clinical trials process though a operations-focus
approach
 Acquire overview of Pharmacology & Biostatistics
 Gain a global perspective on clinical trials management to better respond to the
growing industry
 Learn how to respond to ethical issues inherent in clinical trials
 Gain practical knowledge through real-world case studies discussions
 Learn about Quality control/ Auditing of Clinical Trials
 Appreciate the process of pharmacovigilance and Safety reporting

To Prepare For Jobs As

 Clinical Research Coordinator

 Clinical Research Associates
 Clinical Research Assistants
 Patient Recruitment Executive & more