We will provide Clinical Research certification course at our institute by 6.5 years experienced person on Clinical research in top multinational companies. Clinical research classes are starting on Jully 10th 2010 At 3.00 pm. For enrolling for the course(weekend batch), please call us at 9480917252.Course duration is 3 months (Saturday - 3pm to 5 pm & sunday - 9.00 am to 11.00 am). We will also bring guest lecturers from top MNC's to train our students.

FACULTY PROFILE:

1. Member of  Indian Society for Clinical Research
2. Certified Clinical Data Manager-certified from the Society for Clinical Data Management. USA.
3. Six Sigma Green belt Certified.
4. Member of Drug Information Association
5. 6.5  years of expertise in Clinical Research in top multinational companies.

100% JOB Placement Assistance.

COURSE FEE : Rs. 18000/- Only

* AVAIL DISCOUNT OF RS.3000/- BY PAYING FULL AMOUNT BEFORE FIRST CLASS.

* INCASE OF INSTALLMENTS, STUDENT MUST PAY RS.9000/- BEFORE FIRST CLASS ALONG WITH THE POST DATED CHEQUE OF RS.9000/- ( NO DISCOUNT IS APPLICABLE INCASE OF INSTALLMENTS).

COURSE CONTENTS

 
• Clinical Research Introduction
• Principles of Pharmacology
• Drug Development Process, Clinical Trial terminology (New Drug Discovery)
• Various Stages in Clinical Drug development (Phase I to IV)
• ICH - GCP Guidelines
• Clinical Research Management
• Clinical Research Methodologies
• Preparations & Planning for Clinical Trials
• Bioethics in Clinical Research
• Ethics in Clinical Research
• Roles and responsibilities of IRB/IEC
• Informed Consent Process
• Roles and responsibilities of :
• Sponsor
• Investigator
• Research Coordinator
• Contract Research Organization
• Clinical Data Manager
•  Essential Documentation in Clinical Research
• Regulatory Requirements in Clinical Research
• Clinical Trials Project Planning & Management
• Study Start Up Process
• Conducting BA/BE Studies
• Patient recruitment and retention in Clinical Trials
• Preparation of Protocol, CRF and trial related documents
• Clinical Trial Designing
• Management of Clinical Trials
• Biostatistics in Clinical Research
• Medical Writing
• Historical Perspectives
• Clinical Monitoring Essentials
• Clinical Trial Budgeting
• Finance / Liability and Indemnity in Clinical Research
• Regulatory requirements in India, Japan, USA, Europe
• Quality Assurance and Patent Laws
• Compliance, Auditing & Quality Control in Clinical Research
• Clinical Data Management, Biostatistics, Analysis & Reporting
• Contract Research
• Basics
• Contract research areas
• Contract research delivery model
• Contract research business environment
• Regulatory affairs and contract research
• Case study
• Drug Safety and Pharmacovigilance
• Causality Assessment of Suspected Adverse Drugs Reactions
• Management of Pharmacovigilance Data
• Risk Management in Pharmacovigilance
• Pharmacoepidemiology
• Project