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adv certification course in CR

Course

Advanced Certification Course in

Clinical Research

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Topics Covered:​

1. Clinical Research

  • Clinical research is a field of biomedical science that enables researchers to find out disease treatment intended for use in humans.

  • It is an organized study to investigate new methods of preventing, detecting, diagnosing (or) treating a disease or illness.

  • Clinical research is different from clinical practice. In clinical practice, established treatments are used, while in clinical research evidence is collected to establish a treatment.

  • Pharmaceutical industries as well as Clinical Research Organizations are rapidly expanding in India as well as globally, hence creating a huge demand for qualified and trained clinical research professionals.

  • A massive surge is witnessed in the recent years for the recruitment of clinical research professionals in India as a result, of which India, is now emerging as the hub of clinical research which beholds a great scope of growth in this billion-dollar clinical research industry.

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2. Drug Development

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  • Clinical Development, also called Drug Development, is used to define the entire process of bringing a new drug or device to the market.

  • Development of a drug is a lengthy, complex, and very expensive process, which is entrenched with a high degree of uncertainty that a drug will succeed or not.

  • The ultimate goal of drug development is to bring a new compound with proven therapeutic effect to the market.

  • Time taken for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average.

  • Overall, it takes at least ten years to develop a drug. The average cost to research and develop each successful drug is estimated to be $2.6 billion.

3. Clinical Data Management

  • Clinical Data Management is a process in clinical research, which leads to the generation of high quality, reliable and statistically sound data from the clinical trials.

  • Objectives of CDM-  

  1.     Data collection

  2.     Data Integration

  3.     System/ Data Validation.

  • Clinical Data Management (CDM) is a significant phase in CR which aims to ensure data equality, integrity and compliance with internal protocols and state regulations.

  • Clinical Data Management involves three stages-

  1.     Study Set Up

  2.     Study Conduct

  3.     Study Close Out

  • CDM includes the entry, verification, validation, and quality control of the data generated during the conduct of the clinical trial.

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4. Pharmacovigilance

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  • Pharmacovigilance (PV) refers to the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other drug-related safety problems.

  • Pharmacovigilance staff may be involved to varying degrees in all phases of clinical trials, including the planning, execution, data analysis and reporting of safety information

  • Pharmacovigilance is therefore an activity contributing to the protection of patients and maintaining public health.

  • Objective of Pharmacovigilance

 To undergo treatment, you have to be very healthy, because, apart from your  

 sickness you must withstand the medicine

                                                                                       -Moliere

5. Personality Development

Personal development is the process of improving oneself through developing talents and making better habits in your career, personal life, or both.

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Knowing others is Intelligence,

Knowing yourself is True wisdom,

Mastering others is Strength,

Mastering yourself is True Power.

                                                   Lao Tzu…

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virtual leraning

Virtual Learning

EUNOIA offers its students a comprehensive and a whole new range of learning opportunities using the state-of-the-art technologies available in the market today.

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Technology today has made tremendous advancements and improvements with communication. Virtual learning is a way more effective and efficient way for students to learn and acquire knowledge. Through virtual learning students and teachers are able to communicate at a distance, at any time convenient for them as it also facilitates easy information transfer which also helps students to improve their skills.  

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Online education gives the opportunity for everyone regardless of nationality and place of residence to obtain a degree anywhere in the world.

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Advantages of Online Courses are:

  • To study in congruence with personal pace and educational needs.

  • To use state of the art technologies while training and learning which simultaneously renders time to develop the required skills.

  • To schedule and plan duration of training which gives a room for managing time, an important skill for lifetime.

  • To learn in the most pleasant and productive environment, creating a comfortable atmosphere for students to witness an overall development.

Preparing for an Online Class:

For a student:

Students enrolling at EUNOIA will have to have a laptop/ mobile with internet connection (minimum 2 mbps). A headset/ speaker is recommended for better voice clarity. The link for joining the online class will be either shared through mail or through what’s app to every student in advance.

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For an Institute:

We, at EUNOIA have all the modern facilities integrated with an interactive class using the state of the art technology with all the required accessories.

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