Clinical Research Certificate Program

Nirmal Jyothi Mastery School of Clinical Research (NMSCR)
Enrich Your Knowledge……..Advance your Career


Clinical Research Certificate Program

IS THIS PROGRAM FOR YOU?
These multidisciplinary courses have been designed for professionals interested in moving into the field of pharmaceutical/clinical research. Pharmaceutical companies and hospitals seek out talent professionals with a medicine, dentistry, pharmacy, other life and health science background for these roles because they have a scientific knowledge base, good interpersonal skills, and experience. This program is beneficial for a professional seeking to advance or change specialties, receive training to enter the field of Clinical Research, Clinical Data Management and Pharmacovigilance to obtain a broader understanding of the industry, assist them in grooming and to provide them the placement assistants.

COURSE DESCRIPTION
Clinical Research, Clinical Data Management and Pharmacovigilance are the very eminent areas in the pharmaceutical industry to asses the efficacy and safety of investigational medicinal products, medical devices, diagnostic products intended for human use & for proper documentation & reporting to health authorities. Understanding the huge requirement for skilled professionals in these areas Nirmal Jyothi Mastery School of Clinical Research (NMSCR) (Parent Institute: Nirmal Jyothi Technical Institute is an ITI, affiliated to National Council for Vocational Training (NCVT) & having an experience of successful completion of training programs over the past 25 years) offers advanced certificate program in Clinical Research, Clinical Data Management and Pharmacovigilance and other certificate programs. The field of clinical research is rapidly expanding and offers many career opportunities. This program will give you an understanding of the landscape of clinical research, including the duties of the following specialties:

• Clinical Operations
• Clinical Data Management
• Pharmacovigilance
• Medical Writing
• Regulatory Affairs
• PM in Clinical Research etc

WHO SHOULD ENROLL?
The Clinical Research Certificate Program is ideal for graduates from life sciences (M.Sc/B.Sc), health sciences ( pharmacy, physiotherapy, nursing, dental, medicine, biotechnology, bio medical engineering) graduates, practicing physicians, academics, industry, and others who are interested in the conduct, interpretation, and implementation of clinical research.

CERTIFICATE PROGRAMS
Advanced Certificate Program in Clinical Research, Clinical Data
Management (CDM) and Pharmacovigilance (PV)

Duration: 3 Months
Eligibility: Health Science, Life Science graduates and post graduates

Certificate Program in Clinical Data Management (CDM)
Duration: 3 Months
Eligibility: Health Science, Life Science graduates and post graduates

Certificate Program in Pharmacovigilance (PV)
Duration: 3 Months
Eligibility: Health Science, Life Science graduates and post graduates

COURSE MODULES
Pharmacology
Drug Design And Development
Introduction to Clinical Research
Clinical Trial Methodology
Types and Phases of Clinical Trials
IND Application Process
History & Regulations in CR
ICH-GCP
IRB/IEC
SOPs
Clinical Trial Protocol
CRF Design
Preclinical Studies
Overview of diff. regulatory agencies
Introduction to CDM
Data Review/Data validation &Query Management
Database QC
Database Design
History of Pharmacovigilance
Various Regulations & Acts of Pharmacovigilance
The International Framework for Pharmacovigilance
Individual Case Safety Reports
Collection and Management of Safety Information for investigational and
Marketed products
Safety Information to Regulatory Authorities
Fundamentals of Aggregate Report
Fundamentals of Signal Detection Activity
Evaluating Safety Information & Developing Product Labeling
Pharmacovigilance System Master File
Pharmacovigilance Inspections
Pharmacovigilance Software Overview
Study Set-up
Introduction to Clinical Database
Documents, Guidelines used in CDM
Data Entry
Clinical data Management (CDM)
Regulations in CDM
Quality Assurance and Quality
Control
BA/BE Studies
PK/PD
Basic Biostatistics
Intellectual Property Rights
Medical Writing
Internal Practical And Exams
Live Project Training

Ad Hoc & PLACEMENT ASSISTANCE
• Exposure to PK, CDM & PV Software
• NMSCR is focused on Tie-ups with Relevant Industries to Facilitate the Placement of Our Students.
• Soft Skill Training
• Pre-Interview Preparation & Mock Interviews
• Guest Lectures & Interactions with Industry Experts

COURSE HIGHLIGHTS
Flexible Learning Schedule (Regular , Part Time)
Globally Validated Curriculum Developed by Industry Experts
Free Comprehensive Study Material
Classroom/ Practical Training by Industry Experts
Discussion with Industry Experts to Understand the Industry’s Expectations
Outstanding Training Record
Placement Assistance

ADMISSION
For registration submit the duly filled application form along with copies of school and graduation certificates and two passport size photographs, personally/post at our campus along with the prescribed registration fees.

FOR ADMISSION CONTACT
Nirmal Jyothi Mastery School of Clinical Research (NMSCR)

Bannerghatta Road, Kalena Agrahara, S.O.S. Post,
Bangalore 560076
Ph: 080-26584132
Mobile: 7204671364
Mail: nmasteryscr@gmail.com, nirmaljyothiinstitute@gmail.com