Medstar Institute

Diploma in Clinical research

Clinical research is scientific study that involves people. Individuals volunteer to participate in carefully conducted studies which ultimately uncover improved methods and knowledge on screening, diagnoses, treatment and prevention of disease and on the promotion of health and health care.

COURSE CONTENT

  • BASIC TERMINOLOGIES
  • OUTLINE OF CLINICAL RESEARCH
  • PHARMACOLOGY
  • DRUG DEVELOPMENT
  • OVERVIEW OF CLINICAL TRIAL
  • GUIDELINES AND REGULATIONS RELATED TO CLINICAL RESEARCH
  • ETHICS IN CLINICAL RESEARCH
  • SIGNIFICANCE OF SAFETY REPORTING
  • PROJECT MANAGEMENT
  • QUALITY ASSURANCE AND QUALITY CONTROL
  • CAREER IN CLINICAL RESEARCH / TRIAL

Diploma in Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems.

COURSE CONTENT

  • BASIC TERMINOLOGIES
  • INTRODUCTION TO CLINICAL RESEARCH
  • INTRODUCTION TO PHARMACOVIGILANCE
  • HISTORICAL PERSPECTIVE OF PHARMACOVIGILANCE
  • VACCINE PHARMACOVIGILANCE
  • PHARMACOVIGILANCE OF HERBAL MEDICINE
  • GLOBAL SAFETY MONITORING SYSTEM
  • SETTING UP OF A PV CENTRE
  • MedDRA
  • INTRODUCTION TO ADR AND ADR REPORTING
  • AGGREGATED REPORT
  • SIGNAL MANAGEMENT
  • RISK BENEFIT ASSESSMENT
  • AUDIT AND INSPECTION
  • ROLE AND RESPONSIBILITIES IN PHARMACOVIGILANCE

Diploma in Clinical Data Management

CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of is to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis.

COURSE CONTENT

  • BASIC TERMINOLOGIES
  • INTRODUCTION TO CLINICAL RESEARCH
  • INTRODUCTION TO CLINICAL DATA MANAGMEMENT
  • GUIDING PRINCIPLES AND REGULATIONS ASSOCIATED WITH CDM
  • STANDARD OPERATING PROCEDURE
  • DATA MANAGEMENT PLAN
  • CRF DESIGN
  • DATABASE VALIDATION,PROGRAMMING AND STANDARDS
  • ELECTRONIC DATA CAPTURE
  • DATA PRIVACY AND ENTRY
  • MANAGING LAB DATA AND COLLECTING ADVERSE EVENT DATA
  • MEDICAL CODING
  • SAE RECONCILIATION
  • CREATING REPORT AND TRANSFERING DATA
  • QUALITY MANAGEMENT OF CLINICAL DATA
  • LOCKING STUDIES
  • MIGRATING AND ARCHVING OF DATA
  • ROLE AND RESPONSIBILITIES IN CLINICAL DATA MANAGEMENT

Advanced Excel

The focus of this advanced excel course is to equip the participants with all the knowledge, understanding, and practice they need to use MS Excel easily, effectively, and efficiently. In this course, we cover the entire range of topics, from the very basics to the advanced topics.
Our leading edge curriculum covers fundamentals and more complex data and analytics concepts.

Interpersonal Skills

The Interpersonal Skills workshop will help participants work towards being that unforgettable person by providing communication skills, negotiation techniques, tips on making an impact, and advice on networking and starting conversations.

They will also identify the skills needed in starting a conversation, moving a conversation along, and progressing to higher levels of conversation.
• Understand the difference between hearing and listening.
• Know some ways to improve the verbal skills of asking questions and communicating with power
• Understand what ‘non-verbal communication’ is and how it can enhance interpersonal relationships.
• Identify the skills needed in starting a conversation.
• Identify ways of creating a powerful introduction, remembering names, and managing situations when you’ve forgotten someone’s name.