Courses

  Advanced Post Graduate Diploma in Pharmacovigilance/Drug Safety (Argus Safety), Clinical Research, Clinical Data Management (Oracle Clinical) & SAS Clinical (Base SAS and Advance SAS) with Live Projects
  Advanced Post Graduate Diploma in
Regulatory Affairs
  Advanced Post Graduate Diploma in Medical Coding
 

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  Argus Safety & Oracle Clinical Databases
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Advanced Post Graduate Diploma in Pharmacovigilance/Drug Safety (Argus Safety), Clinical Research, Clinical Data Management (Oracle Clinical) & SAS Clinical (Base SAS and Advance SAS) with Live Projects

About us

Pharmacovigilance

Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal.

Pharmacovigilance plays an important role in the use of medicines by providing information about ADRs in the general population. Knowledge of the adverse effects of drugs is important for effective treatment. Communicating the potential harm of drug-use to patients is a matter of high priority and should be carried out by every prescriber. Information collected during the pre-marketing phase of drug development may not detect rare ADRs. The use of a drug during a clinical trial is under controlled conditions. Clinical trials generally enroll a selected, limited number of patients and may not include certain sections of the population. Drug use in special situations or drug interactions may not be studied. Therefore, the post-marketing surveillance of drugs is important. The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs. Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. ADR monitoring ensures that patients obtain safe and efficacious products. Pharmacovigilance plays an important role in ensuring drug safety.

Pharamcovigilance improves patient care and safety in relation to the use of medicines and all medical and paramedical interventions. It also contributes to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging safety and more effective use.


Oracle Argus Safety database

Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.



CDM - Clinical Data Management


CDM (Clinical Data Management) is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report forms are stored in CDMS. CDM (Clinical Data Management) comprises of designing and deploying clinical study as well as collecting data and managing data for that clinical study. Electronic Processes are used to plan, collect, access, exchange, manage and archive data for the purpose of reporting the entire clinical study data. Adoption of CDM to drive forward drug research is gaining pace, championed by the pharmaceutical industry, primary health providers, CRO industry & USFDA regulators.
 

Oracle Clinical OC/RDC


Hands on training will be provided on Oracle Clinical/RDC. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical Research solution providing highly paid Oracle Clinical Jobs in India, USA, UK, as well as other countries.
 
 

Clinical Research


A new blockbuster drug takes around $850 million to be developed by an international giant. Nearly 70% of which goes towards clinical trials. In the area of clinical trials, India, with its vast and diverse, disease patient population, is now showing competence at nearly a third for the costs compare to the west.

The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration) approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a Clinical trial protocol.

 
 

Course Curriculum

Pharmacovigilance

arrow Clinical Development process
arrow Different phases of Clinical Trials
arrow History and overview of Pharmacovigilance
arrow Introduction and responsibilities of USFDA, EMA and CDSCO
arrow
Pharmacovigilance in India
arrow Adverse Events and its types
arrow Drug Safety in clinical trials and post marketed drugs
arrow
Different sources of Adverse Events reporting
arrow
Different types of AE Reporting Forms
arrow
Expedited reporting and its timelines
arrow Different departments working on Pharmacovigilance
arrow Roles and responsibilities of case receipt unit
arrow
Roles and responsibilities of Triage unit
arrow Four factors for the reportable case
arrow Seriousness criteria of adverse event
arrow
Expectedness or Listedness of adverse event
arrow Causality assessment of the adverse event
arrow Importance and procedure of duplicate check
arrow Data Entry
arrow
Case booking or initiation
arrow
Case processing
arrow
MEDDRA and WHODD coding
arrow SAE narrative writing
arrow Case quality check, Medical review and its submission
arrow
PSUR and its submission timelines

 

 
 

Clinical Research

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

Clinical Data Management

arrow Introduction to Clinical Research arrow Edit Checks
arrow Introduction to Clinical Data Management arrow Data Validation Procedures
arrow Guidelines for CDM arrow Discrepancy Management
arrow Roles and Responsibilities of CDM Team arrow Data Clarification Forms (DCFs)
arrow Clinical Data Management Process and Life cycle arrow Database Locking and Freezing
arrow Data Management Plan arrow Data Storage & Archival
arrow 21 CFR Part 11 arrow Data Coding and Medical Dictionaries
arrow CRF Designing arrow SAE Reconciliation
arrow CRF Annotation arrow Quality Assurance & Quality Control
arrow Data Capture Methods arrow Auditing
arrow Data Entry arrow CDISC Standards
 
 

You will be extensively involved in (Roles and Responsibilities):

» Review of Clinical research documents like Protocols, SOPs, Case Report Forms, Reports and Statistical analysis
» Responsible for completion of all study documentation forms, including Case Report Forms and other study specific documents
» Designing and Developing of CRFs
» Reviewing the Informed Consent Forms
» Interacting with Principal Investigator and alerts Principal Investigator of serious adverse events
» Verification of eligibility of subjects being enrolled by the Investigator
» Reviewing the essential documents in compliance with ICH GCP Guidelines
» Understanding of US FDA Regulatory Affairs in the field of Pharmacovigilance, Clinical Research & Clinical Data Management
» Knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, laboratory information, and drug accountability requirements
» Understanding of the Ethics Committee Guidelines, which safeguards the rights, safety and well-being of trial subjects
» Clinical Trial updates from all the sites and addressing to the core issues
» Maintaining Trial Master File (TMF)
» Maintaining and verifying the clinical data like patient demographics, adverse events, laboratory, medical history, suspects, concomitant medications from source documents, etc.
» Verifying the case information in the database with standard form/source documents
» Compilation of regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports(PSURs)
» Prepare Expedited Safety Reports for submission to Regulatory Authorities
» Reviewing the Pharmacovigilance Plan (ICH E2E)
» Review the serious adverse events (SAE) information received from investigator sites and adverse events (AEs) from post marketing sources for completeness and regulatory compliance
» Review of adverse events for completeness, accuracy & appropriateness for expedited reporting
» Design, develop, review case report forms as per study protocol
» Verifying electronic Case Report Forms (eCRFs)
» Performing manual reviews of clinical data to ensure the completeness and validity of the clinical data
» Verifying the Electronic Records & Electronic Signatures as per 21 CRF part 11
» CDISC Standards (SDTM, ADaM, LAB, ODM)
» Performing data validation & Query Management
» Review the un-resolved discrepancies, raise manual discrepancies where-ever required and close where appropriate to ensure an error free, quality data with no open queries
» Review and understand the study protocol, CRF and the timelines
» Understanding of Data Entry guidelines and CRF Completion guidelines
 

SAS Clinical (Base SAS and Advance SAS)

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Statistical analysis plays a predominant role in finding the safety and efficacy of a drug in Clinical Research. It has assumed tremendous importance with the advanced research in life sciences. It deals with the theories and methods of collection, analysis and interpretation of data. It plays a major role in Clinical Research because data of Clinical Research are of a variable nature. It is very difficult to draw a concrete conclusion from Clinical Research because of inherent differences between two individuals and also from group to group. The extent of this variability in a character is by way of chance, i.e., biological or normal is revealed by statistical methods. Interpretation, drawing conclusions and recommendations play a major role in Clinical Research.

 

SAS Modules:

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

SAS / BASE

arrow Introduction to SAS System & Architecture arrow Keep, Drop and Rename Statements
arrow SAS Windowing Environment arrow Update Statement
arrow SAS Libraries arrow Modify Statement
arrow Variables & SAS Syntax Rules arrow Merging Concepts
arrow Data Step and Proc Step arrow Interleaving Concept
arrow Titles & Footnotes arrow Logical Variables
arrow Proc Print Statement arrow Retain Statement
arrow Proc Print Options arrow Formats and Informats
arrow Set Statement arrow Conditional Statements
arrow Dataset Options arrow SAS Functions
arrow Options Statement arrow Do Statement
arrow Types of Input Statements arrow Randomization
arrow Infile Statement With Options    
 

BASE SAS PROCEDURES

arrow Proc Sort arrow Proc Import arrow Proc Forms
arrow Proc Append arrow Proc Export arrow Proc Datasets
arrow Proc Transpose arrow Proc Compare arrow Proc Printto
arrow Proc Contents arrow Proc Copy arrow Proc Calendar
arrow Proc Format arrow Proc Options    
 

BIOSTATISTICS

arrow Introduction To Biostatistics – Clinical Applications arrow p – Value Interpretation
arrow Frequency Distribution Of Clinical data arrow Sampling Variation
arrow Clinical Data Presentation arrow Probability Concepts In Clinical Trials
arrow Measures Of Centering Constants arrow t-Test – Pharma Applications
arrow Measures Of Dispersion arrow Chi Square test – Adverse Event Analysis
arrow Normal Distribution arrow Correlation & Regression – Estimation Analysis
arrow Null Hypothesis / Alternate Hypothesis arrow ANOVA – Efficacy Analysis
 

SAS / STAT (DATA ANALYSIS)

arrow Proc Means (mean, median, std, n, var, cv, range, q, q3, qrange, p50) arrow Proc Glm
arrow Proc Univariate arrow Proc Freq
arrow Proc Summary arrow Proc Chisq
arrow Proc TTest (Paired and Unpaired) arrow Proc Corr
arrow Proc Anova (One Way, Two Way and Manova) arrow Proc Reg
 

SAS / GRAPH

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

SAS / REPORT

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

SAS / ODS

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

SAS / SQL

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

SAS / MACROS

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

SAS / ACCESS

arrow Import & Export Procedures
arrow Proc Access
arrow Worksheet Statement
 

SAS / CONNECT

arrow Cimport Procedure
arrow Cport Procedure
arrow Using Select Statement
 

You will be extensively involved in (Roles and Responsibilities):

» 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
» CDISC Standards (SDTM, ADaM, LAB, ODM)
» Live SAS Clinical Projects
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