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1 total messages Started by kavitha Tue, 05 Oct 2010 10:21
Practical Training on Clinical Data Management and ClinicalSAS
#212
Author: kavitha
Date: Tue, 05 Oct 2010 10:21
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Moksha Biosciences is a Hyderabad Based Contract Research Organization
to Support Global and Indian Pharmaceutical and Biotech companies in
their Preclinical, Bio analytical and Clinical Development programs.
Our training Division, Moksha Institute of Fundamental Research
(MIFR), is offering Corporate training for industrial people and job
oriented training for academic students in clinical research.


Many companies are involved in clinical research and data management
services in India and abroad

Quintiles-Bangalore, Siro Clinpharm- Mumbai, ICON Clinical Research-
Chennai, Pharmanet”s(SFBC international)-Bangalore, Asian Clinical
Trails-Hyderabad, Clininvent-Mumbai, Dno Clinical Research-Mumbai ,
Ecron Acunova-Mumbai, Synchron-Banglore, Covance Clinical Research-
Mumbai, Parexel-Hyderabad,Prainternational-Mumbai,,Lambda Cinical
research-Mumbai and many more………


There are more than 2,50,000 positions vacant globally and the
salaries vary approximately $40000 per annum for clinical research
coordinator to almost $100000 per annum for business development
manager.


Course modules



CLINICAL RESEARCH –Duration 30 days


1) Introduction to Clinical Research.
2) Introduction to Drug Discovery and Development
3) Regulations in clinical research
4) Designing of clinical research
5) Essentials for Clinical Monitoring
6) Bio Ethics in Clinical Research
7) Roles and Responsibilities of study team.
8)Introduction to CDISC
9) Clinical Trial Process.
10) ICH-GCP
11) 21 CFR 11
12) Clinical Data Management Process.


CLINICAL DATA MANAGEMENT ----- Duration 30 days


1) Protocols and CRF Design
2) Data management Plan
3) Good Clinical Practice & Other Regulatory Guidelines
4) Data Capture Methods and Data Entry
5) External Data Loading And Data Validation
6) Statistical Analysis & Reporting
7) Regulations & Guidelines for CDM
8) Pharmacovigilance.
9) EDC (Electronic Data Capture.)
10) MedDRA
11) Management of ADR.
12) OpenClinica.
13) Oracle Clinical (overview)
14) Safety Data Management.


SAS With Clinical Trails-----Duration 30 days

1) Basics of statistics for Clinical
2) Reporting Clinical Trial analysis.
3). Introduction to SAS in CDM.
4) Base/SAS.
5) SAS/STAT.
6) SAS/GRAPH.
7) SAS Macros.
8) Statistical significance
9) Custom Derived SAS data sets
10) SAS-Programming for NDAs (New Drug Applications)
11) Data Cleaning,


For more details and registrations send mail to



mokshabio@yahoo.com

ADDRESS:
1st Floor, opp. Geetha Hospital
Maruthi Nagar Road
CHAITANYAPURI, Dilshuknagar,
Hyderabad-60 ,PH. 9959861177
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