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Course overview
About Clinical Research Course:
Clinical research investigates the safety and effectiveness of medications, devices, diagnostics, and treatment plans for various health conditions, including prevention, treatment, diagnosis, and symptom relief. This exciting field lies at the heart of medical advancements, and our Clinical Research course equips you with the knowledge and skills to become a vital part of it.
TechnoBridge Systems provides best live online clinical research course with 100% placement assistance in India. Our regulatory affairs diploma syllabus designed by 27+ years experienced industry experts in that we cover all the important aspects like Clinical Research, GCP-IC E6, Clinical Data Management, Drug Development Process, Pharmacovigilance, Regulatory Affairs, Monitoring of Trials, & Protocol Designing.
Course Objectives:
- Master the fundamentals of clinical research, from study design to data analysis.
- Understand the drug development process from pre-clinical testing to market approval.
- Gain expertise in Good Clinical Practice (GCP) and international regulatory guidelines.
- Develop skills in managing clinical trial data, including collection, analysis, and reporting.
- Identify and report adverse events with proficiency in pharmacovigilance practices.
- Learn the intricacies of protocol design and monitoring clinical trials effectively.
- Enhance your employability skills with resume writing, interview preparation, and job placement assistance.
How to Enroll in Clinical Research Course?
Start your journey into clinical research with just a few clicks! Simply visit our website and click the "Register Now" button on the course page. Fill out the application form, and our friendly team will be in touch to guide you through the process.
Clinical Research Course Eligibility
This course welcomes individuals with a passion for research and a life science background. We cater to any life science graduates like B.Sc./M.Sc. (Biology, Microbiology, Nursing) BPharm/M.Pharm, and allied disciplines. No prior experience in clinical research is required, but a strong foundation in science and analytical skills is beneficial.
Clinical Research Course Fee Structure:
We believe education should be accessible to everyone. Therefore, we offer flexible fee structures to suit your needs:
- For one-time payment our clinical research fees is 22000/-
- For payment in 2 installment our clinical research fees is 25000/-
Course Methodology:
Our immersive learning approach ensures you get the most out of your studies:
- Live online & Pre-Recorded Sessions: Learn from industry experts through interactive lectures and engaging discussions.
- Case studies and assignments: Apply your knowledge to real-world scenarios and hone your practical skills.
- Mock interviews: Gain confidence and prepare for job interviews with personalized feedback.
- Unlimited placement support: Benefit from our dedicated placement team that connects you with top companies in the field.
Course Syllabus:
The curriculum is meticulously designed to cover all aspects of clinical research:
- Module 1: Introduction to Clinical Research
- Module 2: Drug Development Process
- Module 3: Good Clinical Practice (GCP)-ICH E6
- Module 4: Clinical Data Management
- Module 5: Pharmacovigilance
- Module 6: Regulatory Affairs
- Module 7: Monitoring of Trials
- Module 8: Protocol Designing
- Module 9: Advanced Topics in Clinical Research
- Module 10: Career Guidance & Placement Assistance
Why Choose TechnoBridge for Online Clinical Research Course?
- 27+ Years Exp. faculty: Learn from industry experts with practical experience and a passion for teaching.
- Comprehensive curriculum: Master all aspects of clinical research from theory to practical application.
- Interactive learning environment: Engage in live sessions, discussions, and practical exercises to solidify your understanding.
- Career-focused guidance: Get personalized assistance with resume writing, interview preparation, and job placement.
- Affordable and flexible fee structure: Choose from various payment options to fit your budget.
- Lifetime access to course materials: Continue learning and revisiting key concepts even after course completion.
Career Opportunities:
The clinical research field offers a plethora of exciting and well-paying careers. With our comprehensive training, you can pursue fulfilling roles in diverse areas, including:
- Clinical research associate (CRA)
- Clinical data manager
- Pharmacovigilance specialist
- Medical writer
- Project manager
Type of companies hiring CR professionals:
- Pharmaceutical companies
- Biotechnology companies
- Contract research organizations (CROs)
- Medical device companies
- Government agencies
- Academic research institutions
What will i learn?
- Knowledge of clinical research industry
- You will be job ready for clinical research domain
- Basics of Clinical Research and its Terminologies
- Stake holders of Clinical Research
- What is the career pathway in Clinical Research
- Process of drug development and understand different clinical trials phases
- In depth study of how clinical trial are conducted along with some case studies.
- Detail study of Good Clinical Practices
- Will be gaining profound knowledge of informed consent
- Will look at the purpose of essential document requirements
- Clinical Data Management
Requirements
- Ideally who has completed their graduation in science, pharmacy or ailed branch also who are interested in medicine field
Curriculum for this course
76 Lessons
16:10:25 Hours
Introduction to clinical research
5 Lessons
00:39:49 Hours
-
Introduction to Clinical Research
00:15:29
-
Terminologies in Clinical Research
00:16:32
-
Advantages of CR in India
00:07:48
-
Introduction to Clinical Research- Notes
.
-
Introduction to Clinical Research Quiz
00:00:00
Drug Development Process
9 Lessons
01:39:25 Hours
-
Overview of Drug Development
00:22:54
-
Clinical trial phase 0
00:04:05
-
Clinical trial phase I
00:19:41
-
Clinical trial phase II
00:10:57
-
Clinical trial phase III
00:15:33
-
Clinical trial phase IV
00:07:26
-
BA/BE Studies
00:18:49
-
Drug Development Notes
.
-
Drug Development Quiz
00:00:00
Good Clinical Practice (GCP)-ICH E6
10 Lessons
02:48:41 Hours
-
History Development of International Regulations in Clinical Research
00:18:14
-
Good Clinical Practices
00:12:04
-
Ethics committee
00:13:46
-
Responsibilities of Ethics Committee Members
00:31:35
-
Investigator Responsibilities
00:13:40
-
Sponsor Responsibilities
00:38:22
-
Protocol and Investigator Brochure
00:06:56
-
Essential Documents
00:34:04
-
Good Clinical Practices- Notes
.
-
Good Clinical Practices- Quiz
00:00:00
Protocol Designing
5 Lessons
01:30:47 Hours
-
Drafting a study protocol
00:30:56
-
Study Design
00:27:58
-
Informed Consent
00:31:53
-
Design of Trial- Notes
.
-
Protocol Designing- Quiz
00:00:00
Monitoring of Trials
8 Lessons
02:24:20 Hours
-
Audits and Inspections
00:25:36
-
Flow of Events
00:36:45
-
Investigational Drug Management
00:26:37
-
Routine Monitoring Visits
00:34:50
-
Site Visit Flow
00:20:32
-
Monitoring of Trials- Notes
.
-
Investigator Product Management - Notes
.
-
Monitoring of Trials- Quiz
00:00:00
Regulation
14 Lessons
02:41:50 Hours
-
Application of Permission
00:15:29
-
Approval of Clinical Trial
00:13:13
-
CDSCO
00:16:30
-
Code of Federal Regulation (CFR)
00:15:10
-
CT_Rules_2019
00:30:06
-
ICMR Guidelines
00:48:03
-
Medical Devices
00:23:19
-
Indian Medical Devices - Notes
.
-
ICMR Guidelines
.
-
DoH Oct 2013
.
-
Guidelines for Industry
.
-
References
.
-
The Belmont Report
.
-
Regulation- Quiz
00:00:00
Safety Reporting
16 Lessons
02:24:08 Hours
-
AE_SAE Reporting Process
00:15:34
-
Adverse Event Reporting
00:22:38
-
Recording of Event
00:11:15
-
Medical Management of Adverse Events
00:09:43
-
Handling Death
00:04:22
-
Unblinding of Drug
00:02:47
-
Clinical Safety and Pharmacovigilance
00:24:38
-
E2A- Clinical Safety and Data Management
.
-
Media 436
.
-
Naranjo Assessment
.
-
Order and Formulate to Determine the Quantum
.
-
SAE Reporting
.
-
Introduction to Aggregate Reporting
00:07:27
-
Medical Assessment -1
00:15:29
-
Medical Assessment -2
00:30:15
-
Safety Reporting- Quiz
00:00:00
Clinical Data Management
9 Lessons
02:01:25 Hours
-
CDM- 21 CFR Part 11
00:15:15
-
CRF_Design_2
00:26:16
-
Introduction to CDM
00:10:44
-
Data Entry Methods
00:15:19
-
Query Management
00:20:14
-
Source data validation
00:26:29
-
Future of Data Management
00:07:08
-
Data Management- Notes
.
-
Data Management- Quiz
00:00:00
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About instructor
Student feedback
Reviews
-
ram tVery knowledgeable sessions for the beginner who wants to pursue their career in clinical research. -
Sneha PatilI benefited a lot from the course.Overall great experience.
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Tushar BehereI am already working in clinical research sector. I wanted to learn a advance knowledge about regulatory and GDPR. I found exactly what I was looking for. This online clinical research course has improved my knowledge about ethics in clinical research without quitting my job. I definitely recommend this course to everyone who are new or working in clinical research or who want to switch there career in clinical research. Trainer delivery is to the point and gripping.Positive Experienced!
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Vishalsingh RajputIt was great experience in TechnoBridge. It has provided online clinical research training.I was not able to crack interview before the join this course but in this Clinical research course I improved my skills and i got job opportunity in IT industry.
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Snehal Shirke
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Poonam Kale
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Sampada Dhamdhere
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Harshada Lawale
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Omkar Thorat
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Ranjeet Kumbhar
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Komal Dhavle
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