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Clinical research Training-Class Room Training-pg diploma in clinical research management

PG Diploma in Clinical Research Management


Course duration - 5 months

5 months ( 3 days a week/1.5  hrs a day)

The pharmaceutical and biotech industry is undergoing a huge expansion worldwide with more emphasis on innovation and personalized medicine. With the changing economic scenario, in emerging economies like India, China, Brazil and Russia, the global pharmaceutical and biotech industry is shifting research and development towards these regions especially to conduct the phases of clinical trials. The pharmaceutical and biotech companies in these growing economy regions are increasing their R&D activity both for innovation of new chemical entity (NCE) molecules as well as for the generic drugs.

In this scenario a large number of clinical research management organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management, clinical research consultancies etc. A huge demand is created for skilled workforce in the clinical research industry.

Clinnovo offers a variety of high quality clinical research training courses, and thus developing increased number of professionals for the clinical research industry equipped with the most latest and relevant knowledge and expertise.

The Post-Graduate Diploma in clinical research  curriculum is fully oriented towards the needs in the clinical research industry.  Our PG Diploma Program provides students the edge that they require to make an entrance in the clinical research industry. It also empowers the professionals working in the clinical research industry with the skills and knowledge to achieve excellence in their careers.

Course Modules for PG Diploma in Clinical Research :


Module 1: Introduction to Clinical Research

Module 2: Drug Discovery and Development

Module 3: Bioinformatics and Drug development

Module 4: Introduction of ICH-GCP

Module 5: Roles and Responsibilities of Study Team

Module 6: IRB and IEC

Module 7: Introduction to Protocol Elements and Development

Module 8: Informed Consent Form and Investigator Broucher (IB)

Module 9: Schedule Y

Module 10: Essential documentation in Clinical Research

Module 11: Clinical Trial Process

Module 12: 21 CFR 11

Module 13: Introduction to CDISC

Module 14: Regulatory Submissions

Module 15: Introduction to Databases

Module 16: Datamanagement Plan

Module 17: Clinical Data Management Process

Module 18: CRF Design

Module 19: EDC ( Electronic Data Capture)

Module 20: MedDRA

Module 21: Pharmacovigilance

Module 22: Adverse Drug Reactions(ADR)

Module 23: EudraVigilance

Module 24: Open Clinica (Comprehensive)

Module 25: Rave(overview)

Keywords : Postgraduate Diploma in Clinical Research Management

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Testimonials

  • "Firstly, i would like to express my sincere appreciation to clinnovo. During my Clinical Research and Datamanagement training, the course coordinator demonstrated patience, understanding, great knowledge and professionalism through out the course. Once again, big THANK YOU." –Samuel Sanni

    "Am so fortune to get training from clinnovo in clinical research and data management. Now am working with a Novartis as a Clinical Data Coordinator. " –Sravani

    "It was very good experience getting training in clinical data management and pharmaco vigilance. I like the way of presentation and case studies. " –Avanthika

    "I have taken the PG Diploma course of Clinical Research and Data management from Clinnovo. In my opinion it is the best course offered. Thanks clinnovo, now am working with ICON." –Subashree

    "This is the best training industry, i found that this is the best one for CR, CDM & SAS. Lecturers make my concepts very clear and i like the friendly and open to discussion classroom environment." –Smitha

    "I got trained with Clinnovo,it was a good experience having hands on experience. Hope i may get a job soon probably in clinical studies or Imaging as i have completed internship for 5 months.This training really helped me." –Padma

    "Being trained in Clinnovo helps importantly as the staff are also involved in projects due to which all concepts of Clinical Research and Data Management explained with very good examples. The trainee gets an idea of real time scenario which is benificial. " –Sakeena Parveen

    "With no knowledge of programming language, I assumed SAS to be impossible to understand. But the efforts taken by the trainer is highly appreciated who made it easy to learn and apply SAS knowledge." –Anthony

    "This course offered me a very strong initial platform to learn SAS and After doing Internship from Clinnovo and I got a job as SAS analyst. " –Sarvani

    "I finished my Masters and joined the SAS training, as I came from biotechnology background, learning SAS was a big challenge. But our lecturer was very good and they explained in a easy way to understand the whole concept." –Suman