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Clinical Research Training Centers, Institutes & Training Course Classes in Pimpri Colony- Listings as of April 20, 2018.

As on April 20, 2018, We have total of 1 Clinical Research training institutes in and around also near to Pimpri Colony area in Pune with best training centers, institute address, Phone numbers, course fee, working hours and student reviews listed.

 

 

training institutes Gurukul Academy of Science & Technology
Pune - Pimpri Colony
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Gurukul Academy of Science & Technology provides best Clinical Research Training, Clinical Research Training classes & Realtime Training Pimpri Colony.
 
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Related Training Courses for Clinical Research in pimpri-colony

 

 

Clinical Research course Content / syllabus at pimpri-colony, pune.

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

 

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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