Dear Student,

Advanced Post Graduate Diploma in Clinical Research, Clinical Data Management, Pharmacovigilance & SAS Clinical (Base SAS and Advance SAS) with Live Projects BioMed Informatics Medwin Hospitals
Features:
Certificate will be provided after successful completion of the course Job experience certificate will be provided till you are getting placement, because of availability of patients data with us from time to time Job experience certificate will be provided till you are going to abroad This is the only place in India where you can get job experience certificate because of availability of clinical records. This job experience certificate will be very much useful in shortlisting process by companies Relieving certificate will be provided after getting the job Resume preparation tips / Interview guidance Printed material will be provided

This is to inform you that we received your query for the Clinical Research & CDM Training. Medwin Hospitals, a Multi Speciality Hospital with excellence in modern health care ventures BioMed Informatics (Member of BCIL-DBT) in the field of Clinical Research by keeping in view of the tremendous applications in improving the quality of the health care. Our candidates employed in Satyam Computers, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, AstraZeneca-UK, Texas Womans University-USA and many more We would like to inform you that the tentative schedule for the next batch is 03-12-2012. Duration is six weeks and the fee is Rs 20,000/-. To reserve the seat immediately, you need to pay Rs.5,000/-. Payment methods: - Do the Cash payment at BioMed Informatics, Hyderabad - Deposit the amount in any branch of ING Vysya Bank in your place Account Name : BIOMED INFORMATICS Current A/C Number : 345011004722 Name of the Bank : ING VYSYA BANK LIMITED IFSC Code : VYSA0003450 - Send a DD/Cheque in favour of BIOMED INFORMATICS payable at Hyderabad Please note that we also provide separate hostel facility assistance for ladies as well as gents. Thanking you, 1

BioMed Informatics Medwin Hospitals B Block First Floor, Nampally, Hyderabad 500 001 Phone: 040 40209750 / 66821025 www.biomedlifesciences.com

Course Curriculum
Clinical Research
Introduction to Clinical Research Pharma Research/Drug Development Process Pre-Clinical Research Clinical Trial Phases (I - IV) IND/NDA/ANDA Ethics in Clinical Research ICH-GCP Guidelines Regulatory Affairs US FDA Guidelines DCGI/Schedule Y EMA CRO Industry IRB / IEC Informed Consent Process Roles and Responsibilities of Clinical Trial Team Site Initiation Study CRF & e-CRF Standard Operating Procedures (SOPs) Investigator Brochure (IB) Protocol Design and Format Investigational Product (IP) Essential Documents for a Clinical Trial Submission & Publication of Clinical Study Report Audits & Inspections

Pharmacovigilance

Introduction to Pharmacovigilance Good Pharmacovigilance Practices Pharmacovigilance Plan (ICH E2E) Classification & Reporting of ADRs Periodic Safety Update Reports (PSURs) for Marketed Drugs (ICH E2C) Safety Signal Detection Safety Signal Assessment Reporting of Safety Signals 2

Management of Safety Signals Indian Scenario Risk Management Process Risk MAPs Pharmacoepidemiological Studies Registers Surveys

Clinical Data Management

Introduction to Clinical Data Management Guidelines for CDM Roles and Responsibilities of CDM Team 21 CFR Part 11 CRF Designing Data Capture Methods Data Entry External Data Loading Data Validation Procedures Data Cleaning Discrepancy Management Query Management Data Clarification Form (DCF) Database Closure and Freezing Data Storage & Archival Data Coding and Medical Dictionaries Safety Data Management (AEs/SAEs) SAE Reconciliation Quality Assurance & Quality Control Auditing CDISC Standards

Live Project

Clinical Data Management System Protocol Designing CRF Designing CRF Tracking Study Event Creation Groups Creation 3

Data Entry Data Validation Discrepancy Management Query Management Database Locking Data Security and Data Privacy

SAS Clinical (Base SAS and Advance SAS) SAS Modules:

SAS / BASE SAS / STAT SAS / REPORT SAS / ODS SAS / GRAPH SAS / SQL SAS / MACROS SAS / ACCESS SAS / CONNECT LIVE SAS CLINICAL PROJECT

SAS / BASE

Introduction to SAS System & Architecture SAS Windowing Environment SAS Libraries Variables & SAS Syntax Rules Data Step and Proc Step Titles & Footnotes Proc Print Statement Proc Print Options Set Statement Dataset Options Options Statement Types of Input Statements 4

Infile Statement With Options Keep, Drop and Rename Statements Update Statement Modify Statement Merging Concepts Interleaving Concept Logical Variables Retain Statement Formats and Informats Conditional Statements SAS Functions Do Statement Randomization

BASE SAS PROCEDURES Proc Sort Proc Append Proc Transpose Proc Contents Proc Format Proc Import Proc Export Proc Compare Proc Copy Proc Options Proc Forms Proc Datasets Proc Printto Proc Calendar

BIOSTATISTICS
Introduction To Biostatistics Clinical Applications Frequency Distribution Of Clinical data Clinical Data Presentation Measures Of Centering Constants Measures Of Dispersion Normal Distribution Null Hypothesis / Alternate Hypothesis p Value Interpretation Sampling Variation 5

Probability Concepts In Clinical Trials t-Test Pharma Applications Chi Square test Adverse Event Analysis Correlation & Regression Estimation Analysis ANOVA Efficacy Analysis Proc Means (mean, median, std, n, var, cv, range, q, q3, qrange, p50) Proc Univariate Proc Summary Proc TTest (Paired and Unpaired) Proc Anova (One Way, Two Way and Manova) Proc Glm Proc Freq Proc Chisq Proc Corr Proc Reg

SAS / STAT (DATA ANALYSIS)

SAS / GRAPH
Proc Plot Proc Gplot Mutliple Plots & Overlay Symbol Statement Title and Footnote Statements Proc Chart Proc Gchart Vertical, Horizontal, Pie Group, Subgroups Proc G3D Proc Gprint Graph-N-Go

SAS / REPORT
Proc Report Column Statements Break/Rbreak Statements Compute Statement Frequency Procedure Proc Tabulate One-Dimensional Tables Two-Dimensional Tables Summary Statistics Proc Summary 6

SAS / ODS
ODS Statements ODS Options Using ODS to Create HTML, PDF, RTF Proc Template Proc Report with ODS

SAS / SQL
Introduction to SAS/SQL Proc Sql Statements Proc Sql Options Set Clause Where Clause Order by Clause Group by Clause Having Clause Distinct Clause Formatting Output Case Expression and Conditional Logic Sql Set Operators Joins in Sql Creating ,Populating & Deleting Tables Alter Table Statement Renaming A Table & Columns Changing Column's Length Aggregate Functions Pass Through Facility

SAS / MACROS
Macro Concepts Macros And Macro Variables Creating Macro Variables Using Macro Variables Invoking A Macro Passing Arguments to Macros Macro Quoting Functions Macro Options Macro Expressions Macro Character Functions Macro Interface Functions

SAS / ACCESS
Import & Export Procedures Proc Access 7

Worksheet Statement

SAS / CONNECT
Cimport Procedure Cport Procedure Using Select Statement

LIVE SAS CLINICAL PROJECT