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Combo Pack

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

Scheduled Batches

22 Jun
Weekends (20 Weekends)
Weekend Online |     07.00 PM - 09.00 PM
22 Jun
Weekends (20 Weekends)
Weekend Class Room |     09.00 AM - 11.00 AM
24 Jun
Weekdays (90 Days)
Weekdays Online |     06:00 AM - 08:00 AM
24 Jun
Weekdays (90 Days)
Weekdays Class Room |     08.00 AM - 10.00 AM
24 Jun
Weekdays (90 Days)
Weekdays Online |     07:00 PM - 09:00 PM
24 Jun
Weekdays (90 Days)
Weekdays Class Room |     10:00 AM - 12:00 PM
24 Jun
Weekdays (90 Days)
Weekdays Online |     10:00 AM - 12:00 PM
24 Jun
Weekdays (90 Days)
Weekdays Online |     08:00 AM - 10:00 AM
24 Jun
Weekdays (90 days)
Weekdays Online |     08.00 PM - 10.00 PM

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

  • CR,CDM,SAS & 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



  • Projects

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


  • Can I attend a demo session before enrollment?


  • 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 ?


  • 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


  • 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






I am glad that I have got training from Covalent in Combopack. The training went well with real time examples and practices.




I recommend this is the best institute to learn from the (Combo Pack)SAS,CR,CDM,SDTM and pharmacovigilance. Because here we get high quality training at optimal cost. The trainers have a good command over the subject and has a good teaching plan. The team has the best support in providing the materials . Thanks to Covalent.




It was really good getting trained in every aspect of Combo Pack from Covalent. It is a very good Institute. It is the place where you get sufficient knowledge to crack an interview in the field of Combo Pack. It makes students capable of working in the corporate world with the only condition of putting a little hardwork and effort.




I had a wonderful time with Covalent Technologies
The study materials good. The support team gets regular feedback and managed to resolve any technical issues. The assignments are very well designed. It is worthble of the money and time.
I especially wanted to thank the faculties and support team for the follow ups and quick replies to my queries. I had a very positive experience.




I would really recommend you to take coaching at Covalent Technologies if you are really interested and mentally prepared to learn something. Very good lecture I would say and do not blame if you don't get offers without your affords. Staff is very helpful when you need technically.




Excellent realtime training on AWS. I got a very clear understanding and confidence after the course, I strongly recommend Covalent Trainings.


Hima Bindhu K


I would like to thank Covalent for the training & knowledge offrered to me during my study of regulatory affairs at the institute overall great learning exeperience. The teaching pattern is very interactive & innovative which includes case studies, group disscussion,presentation, etc.


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