4.91
(23 Ratings)

CR+CDM+PV

Categories: Pharma IT
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About Course

CLINICAL RESEARCH :

  • Description:

Clinical research refers to all research carried out on humans (healthy or sick people). It focuses on improving knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care. It is much framed and respects a precise study protocol and is only realized under certain conditions.

There are 2 main types of clinical studies:

Observational studies (cohort study, epidemiology)

Interventional studies or clinical trials

As part of the development of new drugs, clinical trials are conducted in 5 steps:

Phase 1

First administration in humans

Phase 2

First administration in patients

Phase 3

Therapeutic efficacy

Phase 4

The Marketing Authorization

Phase 5

Monitoring and evaluation of side effects

CLINICAL DATA MANAGEMENT :

  • Description:

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS. A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in patient recruitment efforts.

The CDMS can be broadly divided into paper-based and electronic data capturing systems.

PHARMACOVIGILANCE:

  • Description:

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word “pharmacovigilance” are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation)

Pharmacovigilance is needed for the prevention of drug-induced human suffering and to avoid financial risks associated with unexpected adverse effects. In conclusion, medicines on the market need continuous monitoring in every country.

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What Will You Learn?

  • You would be One of These-
  • Clinical Research Associate
  • Clinical Trial Analyst
  • Medical Writer
  • Clinical Data Analyst
  • Clinical Data Coordinator
  • Clinical Data Coder
  • Drug Safety Associate

Course Content

Clinical Research Material I

  • EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
  • PHARMACEUTICAL MEDICINE
  • THERAPEUTIC AREAS
  • ETHICS IN CLINICAL RESEARCH
  • ROLES AND RESPONSIBILITIES
  • CLINICAL TRAIL PREPARATION
  • ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
  • STUDY START-UP
  • CLINICAL TRAIL MONITORING
  • REGULATORY AFFAIRS IN CLINICAL RESEARCH
  • COMPLIANCE AND AUDITS
  • DATA MANAGEMENT AND BIOSTATISTICS
  • MEDICAL DEVICE TRIALS
  • PROJECT AND VENDOR MANAGEMENT
  • FINANCIAL MANAGEMENT OF CLINICAL TRAILS
  • PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
  • Test Quiz

Clinical Research Material II

Clinical Data Management

Clinical Data Management Material II

Pharmacovigilance Material 1

Pharmacovigilance Material II

Student Ratings & Reviews

4.9
Total 23 Ratings
5
21 Ratings
4
2 Ratings
3
0 Rating
2
0 Rating
1
0 Rating
G
2 years ago
Ikya provides excellent training,friendly faculty,good content,the way of teaching is so understandable,thank you ikya.
G
2 years ago
I highly recommend ikya . These trainers have great level of knowledge and can clearly explain every topic
M
2 years ago
I'm definitely going to continue with ikya Global . It's amazing one
G
2 years ago
Ikya global has the best training and amazing service.I had enrolled in it. Ikya team is so polite and friendly in nature
A
2 years ago
It provides you with the great study environment and they explains in a fantastic manner . It's a certification course
N
2 years ago
Good response from faculty
F
2 years ago
Good selection for training
L
2 years ago
Good quality training and provide good material thankyou Ikya
SR
2 years ago
Best training and placement support at Ikya
HK
2 years ago
Provided in depth knowledge about topics and visualised practically
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