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Clinical Data Research Training Indira Nagar Colony Lucknow, Clinical Data Research Training Institutes & Training Centers Indira Nagar Colony Lucknow, Clinical Data Research Training Classes Indira Nagar Colony Lucknow

List of Best Clinical Data Research Training Institutes Indira Nagar Colony Lucknow, Clinical Data Research Training Centers Indira Nagar Colony Lucknow, Clinical Data Research Course Training classes Indira Nagar Colony Lucknow, Clinical Data Research Cocaching Classes Training Indira Nagar Colony Lucknow, Clinical Data Research Placement Training Indira Nagar Colony Lucknow with address, Phone numbers, course fee, student reviews and training course learning at Indira Nagar Colony area in Lucknow City. As of April 19, 2018, We have total of 1 Clinical Research training institutes in and around also near to Indira Nagar Colony in Lucknow.

 

 

training institutes Medgalaxy Academy of Clinical Research
Lucknow - Indira Nagar Colony
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training institute
Address: 110, Sector 25, Indira Nagar Colony Lucknow-226016
Medgalaxy Academy of Clinical Research provides placement Clinical Research training in Indira Nagar Colony , Clinical Research training classes at Indira Nagar Colony.
 
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Clinical Research related Training courses in indira-nagar-colony

 

 

 

 

 

 

Clinical Research Placement training, Course fees, Trainer Profile in indira-nagar-colony

Medgalaxy Academy of Clinical Research institute located at indira-nagar-colony in lucknow offers 3 Months of Clinical Research training course in Lucknow with 100% Placement Assistance.

The trainers are highly experienced professionals from the industry who have devoted minimum five years in the industry and have hands on eperience in Clinical Research operations, Clinical Data Manag

Clinical Research is the branch of pharmaceutical industry which deals with step by step study of any new drug in human volunteers to evaluate its safety, efficacy and tolerability profile. Clinical Data Management is responsible for review of data collected for accuracy, medical coding and performs SAE review and reconciliation.
Pharmacovigilance (also called Drug Safety Monitoring) team is responsible for adverse event data collection, processing, causality assessment and reporting. The different career options include but not limited to Clinical Data Manager, Drug Safety Scientist, Clinical Research Associate, Clinical Research Coordinator, Medical Reviewer/ Medical Monitors.

 Introduction to Clinical Research

 Drug Development Process

 ICH-GCP Guidelines

 Ethical Guidelines and IRB/IEC

 Informed Consent Form/ Process

 Important Job Roles and Responsibilities

 Investigator�s Brochure

 Protocol

 Study Designs and Randomization

 SAE Review and Reconciliation


 Introduction to Pharmacovigilance (History and Overview)

 Regulatory bodies (Domestic and International)

 Adverse Events

 Sources and Types of Adverse Event Reports

 Regulatory Reporting Guidelines and Timelines

 Case Assessment and Processing

 Triage and Medical Review

 Medical Coding

 PSUR and ICSR

 Introduction to Oracle ARGUS-Safety database

 Case Processing

 Case Narrative writing

 Interview Preparation and Practice session

 

 

Clinical Research course Content / syllabus at indira-nagar-colony, lucknow.

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