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COMBO PACK 2

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. 

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. 

SAS is an integrated software suite for Clinical,advanced analytics, business intelligence, data management, and predictive analytics.

Pharmacovigilance also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Why this course ?

Clinical trials are research studies involving people. They test whether particular treatments are safe and how well they work.
Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
You can use SAS software through both a graphical interface and the SAS programming language, or Base SAS. ... manage and manipulate your existing data to get the data that you need.
The aim of pharmacovigilance is the safer and more effective use of medicines for everyone

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real-time Case Studies

    Live project based on any of the selected use cases on the above selected Domain. 
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class.
  • 24 x 7 Expert Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

Download
  • CR,CDM,SAS (Base, Advanced, Clinical) & PV Content

    Clinical Research (Theory) :

    • Introduction to Clinical Research
    • INDA, NDA, ANDA applications
    • Types, Designs and Phases of Clinical Trials
    • ICH GCP guidelines (ICH E6)
    • Roles and Responsibilities of Investigator and CRA
    • Roles and Responsibilities of Sponsor and CRC
    • Contract Research Organizations-CRO
    • Case Report Form and its Contents with live example
    • Contents of protocol
    • Explanation of Research protocol with live example
    • Informed Consent Form
    • Institutional Review boards(IRB)/IEC
    • Participant safety and Adverse events reporting
    • Safety definitions and reporting requirements
    • Monitoring of Study at participating sites
    • Source Data Verification
    • Investigator's Brochure (IB)
    • Standard operating procedures
    • Essential documents
    • Data Coding using MedDRA and WHODD
    • CRF Design Guidelines
    • SAE/AE Reconciliation

      

    Clinical Data Management (Theory) :

    • Introduction to Clinical Data Management
    • Clinical Data Management Process and Life cycle
    • Explanation of Study Start Up / Set up
    • Explanation of Study Conduct
    • Explanation of Study Close out
    • Clinical Data Management Plan with Example
    • Case Report Forms, Types of CRFs
    • Designing of CRFs
    • CRF completion Guidelines(CCGs) with Example
    • CRF Annotation
    • Data Capture Methods and EDC
    • Data Entry – First pass and Second Pass Entry
    • Edit Check Specifications
    • Data Validation Procedures
    • Discrepancy Types (Univariate, Multivariate, Manual and Indicator)
    • Discrepancy Management
    • Query Resolution
    • Data Clarification Forms (DCFs)
    • Database Locking and Freezing
    • Pre closure Checks
    • Data Coding and Medical Dictionaries
    • SAE Reconciliation
    • 21 CFR Guidelines

     

    Practical Hands training on Oracle Clinical Database/RDC :

    • Introduction to OC window
    • Subsystems in OC
    • Defining Programs and Projects
    • Defining Organization Units
    • Defining Regions
    • Defining Planned Studies
    • Easy Study Design
    • Creating Intervals
    • Creating Events
    • Creating Investigator, Site Records and Assignments
    • Creating Patient Positions and Assignments
    • CRF Design
    • Creating Questions
    • Creating Question Groups
    • Creating and Maintaining DVG's
    • Creating DCM's, DCI's & DCI Books
    • UAT(User Acceptance Testing )
    • Test a Study
    • Test Data Entry
    • Initial Login
    • Key Changes
    • First Pass Entry
    • Second Pass Entry
    • Comparison Reconciliation
    • Update
    • Browse
    • Patient Enrollment
    • Data Validation(Batch validation)
    • Discrepancy Management
    • Data Clarification Forms (DCFs)
    • Audit Trail
    • Locking and Freezing

    RDC (Remote Data Capture):

    • Data entry in RDC
    • Discrepancy Management in RDC
    • CRFs in RDC

     

    Pharmacovigilance/ Drug Safety  (Theory):

    • History and overview of Pharmacovigilance
    • Regulatory Authorities country wise
    • Pharmacovigilance in India
    • Spontaneous reporting
    • Active pharmacovigilance
    • Cohort Event Monitoring
    • 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
    • Aggregate reporting
    • Different departments working on Pharmacovigilance
    • Business workflow of Pharmacovigilance
    • Minimum criteria for the case
    • Causality assessment of the adverse event
    • Expectedness assessment of the adverse event
    • Seriousness assessment of the adverse event
    • MedDRA and WHODD coding
    • SAE narrative writing and Templates
    • PBRER/PSUR and its submission timelines
    • E2A-E2F Guidelines
    • PADAR
    • Explanation of Safety Signals, Signal Detection at UMC
    • Signal publication and communicating signal
    • Risk management

     

    Practical Hands-on Training on Oracle Argus Safety Database :

    Argus Console

    • PV Business process
    • Introduction to Oracle Argus Safety Database
    • Family, Product and License creation
    • Clinical Study configuration
    • Access management : Sites, users and Groups creation
    • Workflow Configuration
    • Case priority Configuration
    • Case Numbering
    • LAM case Numbering
    • Field Validation
    • Code list Configuration
    • Field label Configuration
    • Auto narrative Configuration

    Argus Safety Module

    • Different icons used during the case processing and their purpose.
    • Different tabs used in case processing
    • Case Bookin and Data entry
    • Case Processing of ICSR
    • Case Triage
    • Performing Validation
    • 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
    • Creating PSURs, CTPRs, NDA and IND reports
    • Creating Case data analysis reports
    • Unblinding the clinical trial cases
    • Locking and unloking Case
    • Follow Up for Case
    • Query generation : Action Items
    • Resolving queries using contact Logs
    • Case Bookin in LAM and Routing to Central Safety database
    • MedDRA coding and WHO DD coding
    • Narrative Writing

     

    SAS Base & Advanced Course:-

    • Getting Started with SAS
    • Working with SAS syntax
    • Getting Familiar with SAS dataset
    • Reading SAS datasets
    • Reading SAS datasets
    • Reading Excel worksheets
    • Reading Delimited Raw data files
    • Validating and cleaning data
    • Manipulating data
    • Combining SAS Datasets
    • Enhancing Report (ODS systems)
    • Summary Reports
    • Controlling Input and Output
    • Summarizing Data
    • Reading Raw Data Files
    • Data Transformations
    • Processing Data iteratively
    • Restructuring a Data set
    • TRANSPOSE Procedure

    SQL Procedure

    • Introduction to SQL procedure
    • Basic Queries
    • Displaying Query Results
    • Sub queries
    • SQL Joins
    • Set Operators
    • Creating Tables and views
    • Interfacing SQL with Macro Language
    • Managing Tables
    • Use of SQL in Clinical Trials

    Macro language (SAS Macro)

    • Macro Variables
    • Macro definitions
    • Data Step and SQL Procedure
    • Macro Programs
    • Use of Macro language in Clinical Research

    Free Sessions :

    1. Excell
    2. SQL

     

    SAS Clinical Domain:-

    Clinical Research-Clinical Trials

    • Basics of Clinical Research
    • ICH GCP Guidelines
    • Good programming Practices
    • Use of SAS in Clinical Research
    • Demo project for Clinical trial study

     

    CDISC SDTM Overview:

    • Introduction to CDISC Data Models
    • Understanding CDISC - SDTM
    • Understanding CDISC – ADaM
    • Understanding CDISC – SEND
    • Introduction to Protocol, SAP & CRF
    • Study Populations, Study Day Calculation
    • SAS Programming Guidelines
    • Creating listings
    • Creating Baseline Characteristic Table - 1
    • Creating Baseline Characteristic Table - 2
    • Creating Safety Table-1
    • Creating Safety Table-2
    • Creating Safety (Shift) Table-3
    • TLF & TLC

     

Projects

  • Projects

    We are giving Real-time scenarios for CR, CDM, SAS, PV.

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can provide recording video for particular session or we can arrange you the back up session.

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs
  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Mock interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real-time projects
    Working faculties 
    Lab facilities
    Placement assistance
    Resume preparation
    Doubts clarification

Certifications

  • Course Completion Certificate

    • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
    • Covalent certification has industry recognition and we are the preferred training partner for many MNCs

Videos

Videos

Reviews

Spandana

Fresher

A very nice institute to get trained in courses like  PV, CDM clinical SAS. They provide live demonstration of databases and friendly well knowledged staff. I am feeling it's easy after getting trained here and to cope up with my job.

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Chaitanya

Fresher

I heard Covalent Trainings is the best institute for Combopack training in Hyderabad. Excellent institute and very knowledgeable faculty! Best Course for Combopack training. After successfully finishing my Combopack course there, I must say it is true, If you are looking for Combopack, then Covalent Trainings is the best choice for you.

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Tejasree

Fresher

First of all, I would like to thank everyone at Covalent Trainings for supporting me in taking Combo Pack that includes Clinical Research, SAS, CDM & PV. I have to say, it was my lifetime best decision. The trainer at Covalent comes from MNC with over a decade of domain expertise.

He has covered real-time scenarios in an awesome manner, due to which I got strong confidence and ability to handle real-time tasks after joining an MNC. Thumbs up to Covalent for accommodating such talent.

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Biswa

Fresher

I am glad that I have got training from Covalent in Combopack 2. The training went well with real time examples and practices. The trainers are worth, they hold over a decade of working experience in MNCs. Their knowledge and way of training is really worth every penny.

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