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Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. 

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. 

Pharmacovigilance also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Why this course ?

This helps to produce a drastic reduction in time from drug development to marketing.  Team members of CDM are actively involved in all stages of clinical trial right from inception to completion.
The information collected during the pre-marketing phase of a medical drug is inevitably incomplete with regard to possible adverse reactions, Pharmacovigilance is needed in every country.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real-time Case Studies

    Live project based on any of the selected use cases on the above selected Domain. 
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class.
  • 24 x 7 Expert Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

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  • Cinical Research, CDM & Pharmacovigilance Content

    Clinical Research and Clinical Data Management:- 

    Clinical Research-Topics: 

    • Introduction and Importance of Clinical research
    • Basic structure and elements Clinical Research
    • Ethics and Regulations in Clinical Research
    • Clinical Research contribution to Medical Knowledge
    • Evolution of Clinical Research
    • Clinical Trial design
    • Methodology and management of Clinical research
    • Roles and Responsibilities of people involved in Clinical trials
    • Phases in Clinical trial activity
    • Outcomes of clinical Trials

     

    Clinical Data Management Topics: 

    • Overview & role of CDM in projects
    • Query management
    • Validation
    • Reconciliation
    • Software--Manual
    • Inform
    • RDC
    • Oracle Clinical
    • Additional
    • Brief overview on Medical coding

     

     

    Pharmacovigilance Course:- 

    Module I Pharmacovigilance

    • Introduction
    • Historical Overview
    • Basic principles of Pharmacovigilance in Clinical Trials
    • Methodologies for Pharmacovigilance 

    Module II Regulations in Pharmacovigilance in Clinical Research

    • FDA and EU perspectives
    • Drug Regulatory Activities MedDRA
    • Regulatory Aspects in Pharmacovigilance
    • EudraVigilance
    • Regulations in Pharmacovigilance in Clinical Research 

    Module III Adverse Drug Reactions and Safety Reports

    • ADR Reporting
    • Causality Assessment of Suspected Adverse Drugs Reactions
    • Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
    • Expedited Reporting Requirements
    • Individual case safety reports
    • Periodic safety update reports
    • Electronic safety reporting
    • WHO & safety monitoring 

    Module IV Signal Analysis

    • Definition of signal and type of signal
    • Conducting signal detection in clinical and post marketing surveillance
    • Defining signal in relation to risk/benefit
    • Signal generation to decision making
    • Signal Detection Tools
    • Understanding signals & benefit risk determinations 

    Module V Compliance to Clinical Safety and Pharmacovigilance Regulations

    • Review of benefit-risk assessments and management
    • Scope of Pharmacovigilance inspection and conduct of inspection
    • Internal audit of pharmacovigilance activities of a company
    • Pharmacovigilance inspection reports
    • Pharmacovigilance compliance and inspection
    • Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
    • Scope of Pharmacovigilance inspection and conduct of inspection
    • Internal audit of pharmacovigilance activities of a company
    • Key Functionalities of the Adverse Event Systems
    • Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections 

    Module VI Pharmacovigilance Management and Importance

    • Pharmacovigilance Database
    • Setting up a Pharmacovigilance Centre in Industry
    • Management of Pharmacovigilance Data
    • Risk Management in Pharmacovigilance
    • Data management & software solutions
    • Effective communication in pharmacovigilance
    • Pharmacovigilance in special situations
    • Pharmacovigilance capacity building

     

     

Projects

  • Projects

    We will provide Real Time Scenarios on CR & CDM & PV.

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can provide recording video for particular session or we can arrange you the back up session. 

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs
  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Mock interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real time projects
    Working faculties 
    Lab facilities
    Placement assistance
    Resume preparation
    Doubts clarification

Certifications

  • Course Completion Certificate

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs

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