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Clinical Data Research Training Mumbai City Mumbai, Clinical Data Research Training Institutes & Training Centers Mumbai City Mumbai, Clinical Data Research Training Classes Mumbai City Mumbai

List of Best Clinical Data Research Training Institutes Mumbai City Mumbai, Clinical Data Research Training Centers Mumbai City Mumbai, Clinical Data Research Course Training classes Mumbai City Mumbai, Clinical Data Research Cocaching Classes Training Mumbai City Mumbai, Clinical Data Research Placement Training Mumbai City Mumbai with address, Phone numbers, course fee, student reviews and training course learning at Mumbai City area in Mumbai City. As of June 22, 2018, We have total of 1 Clinical Research training institutes in and around also near to Mumbai City in Mumbai.

 

 

training institutes BITECH
Mumbai - Thane
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training institute
Address: 4TH LOOR,P.TOWERS,NEXT TO MC DONALDS Thane Mumbai google map of 12290
BITECH provides placement Clinical Research training in Mumbai City training classes at Thane.
 
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Clinical Research related Training courses in mumbai-city

 

 

 

 

 

 

 

 

Clinical Research course Content / syllabus at mumbai-city, mumbai.

We gathered most widely used Clinical Research course content used by training institutes in mumbai-city,mumbai. The Clinical Research course syllabus covers basic to advanced level and it may vary based on Clinical Research training classes offered in mumbai-city.

 

It includes various contents such as:
1. INTRODUCTION TO CLINICAL RESEARCH
1.Definition, Types and Scope of Clinical Research, Good Clinical Practices
2.Drug Development Process
3.Careers in Clinical Research

2. ETHICS IN CLINICAL RESEARCH
1.Ethical Theories and Foundations,
2.Ethics Review Committee and Informed Consent Process,
3.Integrity & Misconduct in Clinical Research
4.Conflicts of Interest

3. REGULATIONS IN CLINICAL RESEARCH
Evolution and History of Regulations in Clinical Research, Patents US Regulatory Structure, IND, NDA, ANDA, Post Drug Approval Activities, PMS, FDA Audits and Inspections EURegulatory Affairs, EMEA Organization and Function, INDIAN Regulatory system, Schedule Y- Rules and Regulations.

4. CLINICAL RESEARCH METHODOLOGY
Designing of Protocol, CRF, e-CRF, IB, ICF, SOP Pharmaco-epidemiology, BA/BE Studies Report writing, Publication.

5. CLINICAL RESEARCH MANAGEMENT
Preparation of a successful clinical study, Study management, Project management Documentation, Monitoring, Audits and Inspections Pharmacovigilance Training in clinical research Budgeting in clinical research, Supplies and vendor management

6. BIOSTATISTICS AND DATA MANAGEMENT
Importance of statistics in clinical research Statistical considerations at the design, analysis and reporting stage. Data management, Data validation, SAE reconciliation, query management Software considerations

 

 

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