Pharmacovigilance (Argus Safety), CDM (Oracle Clinical) & SAS Clinical training in hyderabad Online Class Room - Hyderabad
Type : Other Software Courses
Advanced PG Diploma with Placement Support in
Pharmacovigilance - Argus Safety Software, Clinical Data Management – Oracle Clinical Software & SAS Clinical (Base SAS,
Advance SAS and Biostatistics) with Live Projects
BioMed Informatics Medwin Hospitals
(Established in the year of 2000)
? Before joining in BioMed Informatics Medwin Hospitals, You are welcome to check the appointment letters of our previous students issued by MNCs like Novartis, Quintiles, Accenture, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge and so on.
? We never make any phone calls to insist the candidates to join here by making empty promises.
Course Contents:
1. Pharmacovigilance
2. Argus Safety Software
3. Clinical Data Management
4. Oracle Clinical Software
5. Base SAS
6. Advance SAS
7. Live Project
After completion of PG Diploma:
This is the only place in India where you can learn all the softwares Argus Safety, Oracle Clinical and SAS Clinical in single program by which you are eligible to apply in the domains of Pharmacovigilance, Clinical Data Management, Argus Safety, Oracle Clinical & SAS Clinical in Novartis, Quintiles, TCS, Parexel, MakroCare, Synowledge, HCL, Tech Mahindra, Wipro, Accenture and many more….
You are eligible for Pharmacovigilance Jobs
You are eligible for Argus safety Jobs in IT Companies
You are eligible for Clinical data management Jobs
You are eligible for Oracle Clinical Jobs in IT Companies
You are eligible for SAS Jobs in IT Companies
You are also eligible for any healthcare Jobs because of the availability of the patient data in Medwin Hospitals
Features:
• This is the only Place in India where you can have practical Hands-on experience on Argus Safety database and Oracle Clinical Database
• Certificate will be provided after successful completion of the course
• Project experience certificate will also be provided
• Placement Support will be provided
• Resume preparation tips / Interview guidance
• Printed material will be provided
• Practical Hands-on training on Databases
• Argus Safety Database & Oracle Clinical Database
• We also offer Instructor-Led Online Trainings
BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering trainings since the year of 2000 that are helpful for Pharmacy/Life Sciences students to enter into IT Companies and Pharma, Biotech, CRO industries.
Our candidates employed in Novartis, Quintiles, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Interested candidates are kindly requested to fill Quick Enquiry in the website www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Contact:
G.V.L.P.Subba Rao Perfect Guide for a Perfect Learner
CEO
B.Tech from a premier institute of NIT
Abroad returned having more than 20 years of rich experience in Pharma/Life Sciences scenarios
Mobile: 09989684450
BioMed Informatics (Established in the year of 2000)
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad – 500 001
Phone: 040 – 40209750
Website: www.biomedlifesciences.com
Course Curriculum
Pharmacovigilance
• Clinical Development process
• Different phases of Clinical Trials
• History and overview of Pharmacovigilance
• Introduction and responsibilities of USFDA, EMA and CDSCO
• Pharmacovigilance in India
• Adverse Events and its types
• Drug Safety in clinical trials and post marketed drugs
• Different sources of Adverse Events reporting
• Different types of AE Reporting Forms
• Expedited reporting and its timelines
• Different departments working on Pharmacovigilance
• Roles and responsibilities of case receipt unit
• Roles and responsibilities of Triage unit
• Four factors for the reportable case
• Seriousness criteria of adverse event
• Expectedness or Listedness of adverse event
• Causality assessment of the adverse event
• Importance and procedure of duplicate check
• Data Entry
• Case booking or initiation
• Case processing
• MedDRA and WHODD coding
• SAE narrative writing
• Case quality check, Medical review and its submission
• PSUR and its submission timelines
Oracle Argus Safety Database
Argus Console:
• PV Overview
• PV Business process
• Introduction to Oracle Argus Safety Database
• Family, Product and License creation
• Study creation
• Sites, users and Groups creation
• Workflow Configuration
• Expedited Report Configuration
• Case priority Configuration
• Case Numbering
• Field Validation
• Code list Configuration
• LAM (Local Affiliate Module) Configuration
Argus Safety:
• Different icons used during the case processing and their purpose.
• Different tabs used in case processing
• Minimum requirements for a case bookin
• Case Bookin and Data entry
• Case Processing
• Case Routing Based on workflow
• Case Quality check, Medical review
• Duplicate case check or verification
• Report Generation for Regulatory Submission
• Expedited Reports and Aggregate Reports
• Case Bookin in LAM and Routing to Central Safety database
• MedDRA coding and WHO DD coding
• Narrative Writing
• Different Case Studies
You will be extensively involved in Argus Safety:
• Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
• Processing of all incoming cases in order to meet timelines
• Writing a detailed medically oriented description of the events in the form of safety narrative.
• Perform the duplicate search in Argus safety database
• Assessment of seriousness, expectedness/listedness of Adverse Events
• Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and completeness against the source documents provided
• Performing QC review of the cases to meet case processing timelines
• Coding of adverse events with the help of MedDRA and labeling the events
• Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
• Meeting the timelines and supporting global regulatory submissions in expedited reporting of ICSRs
• Preparation of PSURs for regulatory submissions
• Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to central Argus safety
• Codelist Configuration in Argus console
• Creating Sites, Users, User groups
• Creating Products, Licenses, Studies and Expedited Reporting Rules
• Configuring Workflow States and rules
• Knowledge of Advanced conditions; Setting up of field validation to ensure consistency of data
Clinical Data Management
• Introduction to Clinical Research
• Introduction to Clinical Data Management
• Guidelines for CDM
• Roles and Responsibilities of CDM Team
• Clinical Data Management Process and Life cycle
• Data Management Plan
• 21 CFR Part 11
• CRF Designing
• CRF Annotation
• Data Capture Methods
• Data Entry
• Edit Checks
• Data Validation Procedures
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Database Locking and Freezing
• Data Storage & Archival
• Data Coding and Medical Dictionaries
• SAE Reconciliation
• Quality Assurance & Quality Control
• Auditing
• CDISC Standards
Oracle Clinical OC/RDC
INTRODUCTION:
• Introduction to OC window
• Subsystems in OC
STUDY PLAN:
• Defining Programs and Projects
• Defining Organization Units
• Defining Regions
• Defining Planned Studies
STUDY DESIGN:
• Easy Study Design
• Creating Intervals
• Creating Events
• Creating treatment patterns
• Creating Investigator, Site Records and Assignments
• Creating Patient Positions and Assignments
GLIB:
• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Copy Groups
STUDY DEFINITION:
• Creating DCM's, DCI's & DCI Books
• Validation Procedures
• Derivation Procedures
• Test a Study
• Test Data Entry
DATA ENTRY:
• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrollment
• Missing DCMs
STUDY CONDUCT:
• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Data Extract and SAS Extract
• Making Mass Changes
• Locking and Freezing
LAB:
• Labs
• Lab Ranges
• Lab Units
• Lab test questions
• Lab Assignment Criteria
RDC (Remote Data Capture):
• Data entry in RDC
• Discrepancy Management in RDC
• Study and Site Security
You will be extensively involved in Oracle Clinical:
• Designing of electronic Case Report Forms (eCRFs) in Oracle Clinical
• Creation and maintenance of global library objects like DVGs Questions, Question groups, DCMs and DCIs
• Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry
• Generating and Testing data entry screens and validate the range, format, date, missing fields
• Conduct study start up activities, like Study design and Defining Sites, investigators and patients
• Creating, generating and testing Data Validation and Derivation procedures
• Writing edit checks or validation procedures using ranges provided or in accordance with the protocol
• Performing User Acceptance Testing (UAT)
• Data Entry like Initial Login, Key Changes, First Pass and Second Pass Data Entry, Comparison Reconciliation and Update
• Test and execute validation procedures (Both single and batch validation)
• Discrepancy management and Query management
• Generating queries based on validation checks to clarify and improve the quality of the data
• Creating DCFs and maintaining Discrepancies
• Resolving queries and updating the database.
• Review of un-resolved discrepancies, raise manual discrepancies wherever required and close where appropriate.
• Improving the quality of the data to ensure an error free, accurate data with no open queries
• Establishing and coordinating the timely completion of the database lock procedures.
• Reviewing clinical data as per SOP, protocol, and study specific guidelines
• Knowledge of Data Extract and SAS extract views
• Maintaining Lab ranges, Lab units, Lab test questions
• Data entry in RDC and Discrepancy Management in RDC
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
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
• 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
• Probability Concepts In Clinical Trials
• t-Test – Pharma Applications
• Chi Square test – Adverse Event Analysis
• Correlation & Regression – Estimation Analysis
• ANOVA – Efficacy Analysis
SAS / STAT (DATA 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 / 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
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
• Worksheet Statement
SAS / CONNECT
• Cimport Procedure
• Cport Procedure
• Using Select Statement
LIVE SAS CLINICAL PROJECT
You will be extensively involved in:
• Extracting the data from various internal and external databases (Oracle, MS Access, Excel spreadsheets) using SAS/ACCESS, SAS/INPUT
• Developing programs for converting the Oracle data into SAS datasets using SQL Pass Through Facility
• Clinical trial data analysis with different Statistical Procedures
• Using various statistical procedures to find out the efficiency of the drug as per 21 CFR USFDA Guidelines
• Interpretation of p-value and drawing conclusions
• Assigning subjects to different treatment arms with SAS Randomization Programs
• Creating the reports using the SAS procedures and using ODS statements to generate different output formats like HTML, PDF, RTF and excel to view them in the web browser
• Creating the statistical reports using Proc Report, Proc Tabulate and SAS Macro
• Thorough understanding of Protocol, Statistical Analysis Plan (SAP)
• Analyzing the data and creating tables according to the Statistical Analysis Plan (SAP)
• Generating the demographic tables, adverse events and serious adverse events reports
• Using the SAS procedures (MEANS, FREQ, SUMMARY, TRANSPOSE, TABULATE, REPORT etc) and SAS/STAT procedures (REG, CORR, GLM, ANOVA and UNIVARIATE etc.) for summarization, cross-tabulations and statistical analysis
• Manipulation of SAS datasets using SET, MERGE, UPDATE, MODIFY and Conditional statements
• Generating Graphs and Figures using PROC CHART, PROC GCHART, PROC PLOT, PROC GPLOT and Graph-N-Go
• Validation and QC of the efficacy and safety tables
• Using PROC EXPORT and Export wizard to Transfer SAS data to external data sources
• Providing programming support for the creation and maintenance of programs used in Data Management, Data Validation, Data Cleaning and Statistical Report Generation
• Extensive Applications in SAS/SQL, SAS/ACCESS, SAS/CONNECT and SAS Macros
• Generating Tables, Listings, Figures/Graphs (TLFs or TLGs)
• Working with datasets such as DM (Demographics), LB (Laboratory), MH (Medical History), AE (Adverse Events), VS (Vital Signs), CM (Concomitant Medication)
• Manipulation and Reporting of clinical data using PROC SQL
• Extensive programming in writing and debugging the Macro routines and applying Macro variables in SAS program
• Live SAS Clinical Projects
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