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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. 

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 ?

This helps to produce a drastic reduction in time from drug development to marketing.  Team members of CDM are actively involved in all stages of clinical trial right from inception to completion.
The information collected during the pre-marketing phase of a medical drug is inevitably incomplete with regard to possible adverse reactions, Pharmacovigilance is needed in every country.

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
  • Cinical Research, CDM & Pharmacovigilance 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

Projects

  • Projects

    We will provide Real Time Scenarios on CR & CDM & 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

Haneef

Fresher

I recently completed my CDM course from Covalent Trainings, Hyderabad.

Their training was very practical and covers most of the corporate scenarios. The best part is that now
I understood how this technology contributes to the major projects.

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Suma

Fresher

Excellent realtime training on Tripack. I got a very clear understanding and confidence after the course, I strongly recommend Covalent Trainings & CDM is very understanding subjet.

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Hemanth

Fresher

I strongly recommend Tripack that includes Clinical Research, CDM & Pharmacovigilance, it’s a best choice if you want to enter into this industry. Faculty & staff are very supportive. I liked their job-oriented real-time training, that covers almost all real time scenarios, simply superb.

readmore...

Madhu Mishra

Fresher

Very good experience in joining in Covalent they taught me CDM, PV & CR,i got very good and excellent knowledge about the three subjects,and my skills are improved due to seminars or presentations and due to group discussions ,I gained confidence to face any interview,am able to convey the information.

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Guruvaiah Goud

Senior Executive

Covalent is the best training and placements company in India. I have undergone Pharma Training @ Covalent they trained us in different departments like Production, QA, QC, R & D, and RA. With their training I got placements in Dr.Reddy's. Thank you Covalent Technologies.

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Reeta Prajapathi

Drug Safety Associate

I want to thank Covalent for their support. After completion of my B.Pharm(2017), I have joined Covalent for SAS Clinical and PV Training for 3 Months program. After completion of training with in a month duration I got placed in TCS in Pharmacovigilance Department.

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Vikash Reddy G

Drug Safety Associate

I am very glad to inform you that I got an opportunity with TCS, Mumbai Location. Covalent has helped me in achieving my goal. It has given me a perfect foundation in Pharmacovigilance for my success. This is the best place for freshers who want to achieve Jobs in Pharmacovigilance in IT & Pharma Industries.

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Prathiba Chitra

MBBS, DSP

I am greatful to Covalent, which provided me best guidance in opting the best course for better career after completion of my MBBS and today I am associated with Quintiles, Banagalore.

readmore...

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