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Clinical Research and Real world evidence

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Course offered by Ved Prakash

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Syllabus of CR Module is described below:

In this CR module we will cover entire lifecycle of clinical research starting drug discovery to drug development. I have 7 years of experience in clinical data management; experienced in handling multiple protocols starting from study set up with study conduct to study closeout phase for global clients in therapeutic areas like oncology, neurology, hematology, and Immunology. I will give you real time example and dataset to practice whih will help you to crack interviews and make you confidence. Post enrolling this course I will make sure you have enough knowledge and experience, same a 2+ years person in clinical research industry. Below are the topics to be covered in this module:

1- Introduction to Clinical Research & Phases in CR

2-Screening, Randomization & Blinding in Clinical Research

3-Clinical Research Design

4-ICH-GCP & Drug Regulation

5-Protocol & PubMed search

6-Responsibilities of Investigator & CRA

7-Responsibilities of Sponsor & CRO

8-Responsibilities of Ethics Committee

9- SAE Reporting

10-Data curation of Clinical trials and Health outcome data from PubMed ClinicalTrials.gov, EU registry & Clinical study report.

 

 

About the Trainer

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Ved Prakash

Master of Pharmacy (M.Pharm) from Osmania University in 2018

5 Years of Experience

7 years of experience in clinical data management; experienced in handling multiple protocols starting from study set up with study conduct to study closeout phase for global clients in therapeutic areas like oncology, neurology, hematology, and Immunology.

I love to teach clinical research and Clinical data management to life science graduates and I have been teaching students since 2020.

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