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Cliantha AcademyCliantha Academy
  • About us
    • Overview
    • Our Team
  • Our Courses
    • Certificate Course in Quality Management System
    • Certificate Course in Clinical Data Management (CDM)
    • Certificate Course on Clinical Research
    • Crash Course – Good Clinical Practice
    • Crash Course – Monitoring in Clinical Trial
    • Certificate Course on Clinical Research Co-Ordinator
  • Alumni
    • Testimonial
    • Placement
  • Gallery
    • Glimps of Cliantha Academy
Contact Us
Cliantha AcademyCliantha Academy
  • About us
    • Overview
    • Our Team
  • Our Courses
    • Certificate Course in Quality Management System
    • Certificate Course in Clinical Data Management (CDM)
    • Certificate Course on Clinical Research
    • Crash Course – Good Clinical Practice
    • Crash Course – Monitoring in Clinical Trial
    • Certificate Course on Clinical Research Co-Ordinator
  • Alumni
    • Testimonial
    • Placement
  • Gallery
    • Glimps of Cliantha Academy

GTU-CCE – Clinical Research Certificate Course

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  • GTU-CCE – Clinical Research Certificate Course
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Cliantha Academy, an affiliate of Cliantha Research, offers offline clinical research courses that are widely recognized in the clinical research industry, enhancing both your employment opportunities and the outcomes of trials.

Useful Links​

  • Why Cliantha Academy
  • Our Team
  • Placement
  • Contact Us
  • Testimonial Videos

Courses

  • Certificate Course on Clinical Research
  • Crash Course – Monitoring in Clinical Trial
  • Crash Course – Good Clinical Practice
  • Certificate Course on Clinical Research Co-Ordinator
  • Certificate Course in Quality Management System
  • Certificate Course in Clinical Data Management (CDM)

Contact us

  • 2nd floor, 17, Sigma Corporates, Sindhubhavan road, Opp. Courtyard Marriott, Bajarang Cross road, Ahmedabad, India, Gujarat
  • 9316733464
  • academy@cliantha.com
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Duration : 250 Hours

Mode : Online/Offline/Hybrid

Course Overview

  • Clinical Research is essential for developing new treatments, ensuring patient safety, and advancing medical knowledge. It helps evaluate the effectiveness of drugs and medical devices through rigorous testing and regulatory compliance. The field offers vast career opportunities in Clinical Research Industry. Cliantha Academy provides industry-focused training with hands-on experience and placement assistance. Join us to build a successful career in Clinical Research!
  • The entire training module is structured as per the flow of a Randomized Clinical Trial and includes discussion on activities, documents, personnel required during Planning & Setup.
  • Planning & Setup
  • Study executio
  • Study close out, analysis, reporting
  • It is designed to include the Point of view of all stakeholders in a regulated clinical trial Sponsor
  • Sponsor
  • Investigator / Sites
  • Ethics Committee
  • The modules are dynamically designed to include all critical formats of a GCP compliant Clinical Trial
  • Learning is multimodal and emphasized through Hands on activities, group exercises, electronically integrated activities, competitive quizzes, open discussions/debates, role play, and activities, audio visual aids. The reliance on one way lecture format through power points slides is lean and situational.
  • The training workshop will be a multimodal format – Class room sessions, group activities, PPT, Learning &Training software, Quizzes, site visits and Interaction/Session with Industry Expert.
  • All critical aspects such as Site initiation, ICF, AE/SAE reporting, Essential documents, TMF etc will be through filling and filing of dummy documents and simulation exercises.
  • Our training program features engaging and interactive content meticulously crafted by skilled content writers and industry experts. The comprehensive curriculum includes audio-visual elements, interactive quizzes, illustrative examples, images, and in-depth case studies. Designed to enhance learning and retention, this innovative approach ensures a dynamic and enriching training experience. Training execution and tracking of participants' progress take place through professional, validated eLearning software.
  • Post training, Final assessment / Exam for each participant will be done before concluding the training as successful

Why enroll in This Course?

  • Earn GTU Certificate with 16 Credits
  • 16 Credits are Claim for Academic bank of Credit
  • Gain practical knowledge from industry experts
  • Hands-on training in clinical trial coordination
  • Learn global and Indian regulatory guidelines
  • Enhance your career prospects in clinical research

Course Content

Sr

Topic

1

Drug Development and role of regulated Clinical Research

2

Healthy Volunteer Clinical Trial Setup and Study Flow

3

Patient based Clinical Trial Setup and Study Flow

4

The stakeholders in Clinical trials Roles and responsibilities of Sponsor, Ethics Committee, Investigator/Sites and Regulatory Agency

5

Clinical Trial Study Design & Randomization

6

SQV, Site Selection & Initiation, Site Monitoring, Site Close Out

7

Ethics Committee/ Regulatory pathway

8

Investigational Products - Managing, Handling & Accountability

9

Good Clinical Practice (ICH E6) & Good Documentation Practices

10

New Drug Clinical Trial Rule (NDCT) & ICMR Guideline

11

Basic Orientation to Regulatory Bodies (DCGI, EMA, MHRA, USFDA)

12

Trial master file –Set up & Maintenance, Practical Aspects

13

Informed Consent Procedure & Case Studies

14

Patient/Participant Recruitment, Retention, and Compliance

15

Guidelines for Reporting of AE/SAE

16

Audit Plan, Audit & Audit Report

17

Overview of Clinical Data Management (CDM) in Clinical Trial

18

CTRI & Importance of Various Regulatory Forms

19

Various Job Role in CT and Roles and Responsibility

20

Clinical Trial Site Visits & Industry Expert Sessions

21

Communication & Public Speaking Workshop

22

Career Counseling

23

Expert HR Lecture | Mock Interviews | Personal Mentoring

24

Social Media Guidance | Interview Do’s and Don’ts

25

CV Preparation | Email Etiquette | MCQ based final Exam

26

Placement Assistance

Start your journey as a Clinical Research Professional - Enroll Today!
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Cliantha Academy, an educational initiative by Cliantha Research, offers various clinical research courses that are widely recognized in the clinical research industry, enhancing both your employment opportunities and the outcomes of trials.

Courses

  • Why Cliantha Academy
  • Our Team
  • Placement
  • Contact Us
  • Testimonial Videos

Useful Links

  • Certificate Course on Clinical Research
  • Crash Course – Monitoring in Clinical Trial
  • Crash Course – Good Clinical Practice
  • Certificate Course on Clinical Research Co-Ordinator
  • Certificate Course in Quality Management System
  • Certificate Course in Clinical Data Management (CDM)

Contact us

  • 2nd floor, 17, Sigma Corporates, Sindhubhavan road, Opp. Courtyard Marriott, Bajarang Cross road, Ahmedabad, India, Gujarat
  • 9316733464
  • academy@cliantha.com
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