Course Details

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Advance Diploma in clinical Research (Offline)


What are clinical trials?
Clinical trials are a form of clinical research that follows a defined protocol that has been carefully developed to evaluate a clinical question. A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions.
Although people commonly associate clinical trials with drug trials, in which new medications or combinations of drugs are tested for their effectiveness against a disease, clinical trials may also evaluate whether interventions such as counseling or lifestyle modifications have an effect on disease progression. Clinical trials may be conducted on people who have a disease or on healthy people, depending upon the purpose of the research.
 
What are the phases of a clinical trial?
Clinical trials are classified into different phases, with each phase having a different purpose within the trial.
Phase I trials involve a small group of people (20-80) and are concerned with determining a safe dose of the drug being studied as well as its potential side effects.
In Phase II, the treatment or drug is tested in more people (100-300) for further evaluation - this time, determining the time of the drug or treatment's effectiveness against the disease for which the patient is being treated. Even more people (1,000-3,000) are participants in Phase III of a trial,
In Phase IV trials, conducted after a treatment has been approved for specific indicated conditions by the FDA, post-marketing studies are carried out to collect more information about the optimal use of the drug or treatment and to further evaluate its side effects

Course Objective:
Pacifix Research is the premier and leading institute dedicated to promote ethical research and high-quality development in Clinical Research, We provide Best industry knowledge of Clinical Research with a broad understanding of the details clinical research concepts.
In this course we are providing best online training with the help of new developed technology.
After COVID 19 now world will be entering into new education system, learning tools so with the help of these things we have launched this online clinical research programs for new learners.

Course Content:
 In this program below technical points will be covered throughout the syllabus.as per industry standards and Regulatory standards.

  • Module 1 – Introduction to Clinical Research

  • Module 2 – New Drug Development

  • Module 3-  Drug Safety and Pharmacovigilance

  • Module 4 – Ethical Guidelines in Clinical Research

  • Module 5 – Ethics in Clinical Research

  • Module 6 – Regulations in Clinical Research

  • Module 7 _  Clinical Trial Management

  • Module 8 – Clinical Trial Documentation

  • Module 9 – Quality in Clinical Trials

  • Module 10 – Clinical Data Management

 
Class room training will be provided by industry faculty involving Lectures and PowerPoint Presentations, hands on document designing in clinical research. In this course whole syllabus will be covered in detail mode.
 
Assignments 
CRF’s (Case Record Forms),
IC (Informed Consent Forms),
PIs (Patient Information Sheets),
Protocol Designing,
PMS (Post Marketing Surveillance Studies)

Duration of course:
Three Months.

Eligibility:
Minimum eligibility criteria for application to the online course would be either of the following:

 MBBS                                    BDS

 BHMS                                   BAMS

 Physiotherapist                   B.Pharm

 M.Pharm  ?                            Pharma D

Graduates/ Post Graduates in Sciences/Life sciences/ BioSciences with any of the following subjects-Chemistry, Botany, Zoology, Biochemistry, Microbiology, Genetics and Biotech.
 
Admission Procedure
The admission process will be done as per Pacifix research procedure & one and one Personal Interview conducted by Pacifix Research Team.

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