Post Graduate Diploma/Executive Diploma in  Clinical Research

IGMPI

The Post Graduate Diploma/Executive Diploma in Clinical Research has been structured by experts from the industry themselves and thus comprehensive coverage and understanding of the industry and its functional areas is promised. The online programme has following tempting features which are definite to benefit one to all participants of the programme:

Comprehensive information, clearly targeting the healthcare industry; Well-structured programme, intelligently put together under guidance of industry experts from same field; Easy to use, browse and explore e-tools woven remarkably well into the programme make the study material, lectures, online database, examination preparation modules as well as assessment papers easily accessible.
E-tools make the programme self-paced and online exams make things easier and less complicated for the participants. Clinical Research Industry in constantly growing and recessions proof but at the same time very challenging and dynamic. Only professionally trained employees get to make their mark and reach pinnacles of success in this fast moving sector of the health care industry. Thus IGMPI targets to teach, train and polish aspirants in Clinical Research professionals with clear understanding and complete knowledge of this industry and its working.
The programme is meant for all those keen on being a part of Clinical Research industry, so all graduates, post graduates and even working professionals can apply for the programme and affirm a strong position in the industry.
The programme is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Regulatory affairs as their career choice.

On successful completion of this programme, participants are expected to have better understanding of the requirements of GLP for the efficient working of a testing laboratory by applying the knowledge into practice. The programme provides an overview of ISO / IEC 17025: 2005 as well as the common requirements of GLP Compliance (OECD & FDA) as applicable to various testing Laboratories and research organizations. This will also include recent developments related to computer validation.

Programme Modules

Module 1: Introduction to Clinical Research Process

  • Clinical Research Industry
  • Difference between Clinical Research and Clinical Trials
  • Clinical Research Terminologies
  • General Medical Terminologies
  • Module 2: General Pharmacology and Mechanism of Drug Action

  • Basics of Pharmacology
  • Pharmacodynamics
  • Pharmacokinetics
  • Routes of Administration
  • Dosage forms
  • Module 3: Drug Development Process and Clinical Drug Development Phases

  • Drug discovery
  • Target Identification
  • Lead Identification
  • Lead Optimization
  • Preclinical studies
  • Module 4: Historical Perspectives of Clinical Research

  • Evolution of Ethical and Regulatory Framework
  • Nuremberg Code, 1946
  • Declaration of Helsinki
  • Thalidomide Tragedy
  • Belmont Report
  • Schedule Y, Drugs and Cosmetics Act 1945
  • Module 5: Ethical Issues in Clinical Research

  • History of ICH
  • ICH Guidelines
  • ICH GCP- E6 R2
  • ICMR Ethical Guidelines
  • Ethics on use of Placebo in Clinical Trials
  • Module 6: National and International Regulations Governing Clinical Trials

  • CDSCO, India
  • ICMR, India
  • USFDA, USA
  • EMEA, Europe
  • MHRA, UK
  • TGA, Australia
  • Module 7: Clinical Research Stakeholders and Core Team: Roles and Responsibilities

  • Investigator
  • Sponsor
  • Contract Research Organization (CRO)
  • Clinical Research Coordinator (CRC)
  • Clinical Research Associate (CRA)
  • Module 8: Research Methodology and Applied Biostatistics

  • Defining the Research Problem
  • Sampling Design
  • Hypothesis testing
  • Parametric and Non parametric test
  • Scientific Writing
  • Module 9: Types and Designs used in Clinical Research

  • Diagnostic and Treatment Trials
  • Interventional and Observational studies
  • Case control and Cohort studies
  • Randomized controlled trials
  • Quasi experiments
  • Module 10: Clinical Research Documentation

  • Essential Documents before, during and after the trial_ICH GCP
  • Protocol
  • Informed Consent Documents
  • Investigator’s Brochure
  • Case Report Form
  • Clinical Study Report
  • Module 11: Clinical Trial Data Management

  • Introduction to data management
  • Electronic Data Records
  • E-CRF & Interactive Web Response Systems
  • Database locking and unlocking
  • Good Documentation Practices
  • Module 12: Pharmacovigilance and Safety Monitoring

  • Adverse Drug Reaction
  • Serious Adverse Events (SAE)
  • SAE Reporting timelines
  • Pharmacovigilance methods
  • Signal Detection and Data Mining
  • PvPI
  • Risk Management Plan
  • Module 13: Quality Assurance and Quality Control in Clinical Trials

  • Introduction to Quality Management System
  • Quality Assurance
  • Quality Control
  • Audits and Inspection
  • Types of Audits
  • General Audit Observations
  • Module 14: Pharmacoepidemiology and Pharmacoeconomics

  • Pharmacoepidemiology- Methods
  • Clinical Application of Pharmacoepidemiology
  • Principles of pharmacoeconomic analysis
  • Pharmaceutical Outcomes evaluations
  • Module 15: Medical Device Clinical Trials (MDCTs)

  • Medical Devices Rules, 2017
  • Classification of Medical Devices
  • Materiovigilance
  • Phases of Medical Device Clinical Trials
  • Module 16: Medical Writing (Protocol, ICD, CRF, CSR) for Clinical Trial and Regulatory Submission

  • Case reports
  • Article writing
  • Designing Clinical Trial protocol
  • CRF Designing
  • Informed Consent Documents
  • Clinical Study Reports
  • Module 17: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

  • E-Consent (Audio visual consent)
  • E-Patient Reported Outcomes (e-PRO)
  • IWRS
  • Telemedicine
  • Patient e Diaries
  • Remote Patient Monitoring
  • Module 18: Clinical Trial- Latest Updates

  • ICH-GCP_E6 R3
  • NDCT Rules: 2019 & its Amendment (2023)
  • ICMR-HMSC
  • Recent CDSCO Notices
  • NABH Ethics Committee Standards, etc.)
  • Module 19: Industry Based Case Studies

    Eligibility

    Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

    Programme Duration

    The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).

    Registration

    The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

    Programme Deliverables

    A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

    • – Assignments for all the programme modules for continuous evaluation and guidance.
    • – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
    • – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
    • – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
    • – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
    • – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
    • – All learning and training delivery initiatives shall be conducted in English.

    Examination & Certification

    IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme. This programme is approved by Quality Council of India (QCI), Government of India

    All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will receive a certificate of Post Graduate Diploma/Executive Diploma in Clinical Research by Faculty of Clinical Research, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

    Placement Assistance & Corporate Relations

    The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

    In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical like IQVIA, Parexel, Syneos Health, Fisher Clinical Services, Dr. Reddy’s Laboratories, Divi’s Laboratories, GVK Biosciences, Avra Labs, SRL Ranbaxy, Torrent Pharmaceutical Ltd., Novartis Life Sciences, Jubilant Lifesciences Ltd., Aurobindo Pharmaceuticals Ltd., Venus Remedies Ltd., etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

    Future career prospects of Training in Clinical Research

    IGMPI offers professional and industry oriented training in Clinical Research thus opening doors for entry into the industry. PG diploma in CR adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to sustain and grow in the industry.
    PG Diploma in Clinical Research is a broad spectrum programme which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry. With the completion of this programme the candidate gets to select from varied work areas of the industry/sector of his/her interest. Knowing all faces of the industry, candidate can target to specifically enter the drug development, CTs, Data Management, Regulatory Affairs, Quality Assurance or Post marketing Surveillance teams of various Pharmaceutical companies. Same is true for the professionals who are already a part of the industry but are keen on making lateral movement in their company by shifting to other department.


    View Prospectus

    Programme Fee Details

    How to apply

    For further enquiries, write to or call us on:
    info@igmpi.ac.in / 18001031071 (Toll Free) , Phone: +91 11 26512850

    Pharmaceuticals | Food | Clinical Research | Healthcare | Medical Coding | Medical Device | Nanotechnology | IPR

    Placement Testimonials


    All existing and old students and training participants are requested to write to our Corporate Resources division on info@igmpi.ac.in along with your updated resume mentioning their Enrollment No. for registration with our Placement Cell asap, if not registered yet.


    Moderated by Shri Vinod Arora, Principal Advisor, IGMPI


    Moderated by Shri Vinod Arora, Principal Advisor, IGMPI

    Moderated by Shri Vinod Arora, Principal Advisor, IGMPI


    GMP: A continous process
    Fighting fakes with technology
    Trends in lab design
    Oral solid dosage forms: Trends and opportunities
    Optimising FR&D to expedite regulatory complaince
    By Shri Vinod Arora, Principal Advisor, IGMPI


    Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like

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