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Clinical Research & Clinical Data Management

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. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

Why this course ?

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. 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. They should have adequate process knowledge that helps maintain the quality standards of CDM processes.

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

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  • Clinical Research (CR)

    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 (CDM)

    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

Projects

  • CR & CDM Projects

    We will provide Realtime scenarios.

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can give backup calss for particular session and same session you have to attend another batch also

  • 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?

    • Job Support till getting an Opportunity 
    • Resume preparation
    • Mock interviews
    • Placement Assistance
  • What Features do you provide?

    • Classroom & Online sessions with corporate trainers
    • Course Material
    • Real time projects with industry experts
    • Regular Assignments (Tasks)
    • Placement assistance
    • Resume preparation
    • Doubts clarifications

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

Thanvi

Fresher

The best part is that now. I understood how this technology contributes to the major projects.

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Sudheer Kumar T

Fresher

Covalent is one of the best training Institute for Clinical Data Management training. Me and my friend have joined Covalent for CDM Training and realtime projects. We have already learned CDM subject but no software, But at covalent we have learned CDM with software with the realtime scenarios. and after completion of the course I got job in Global Data Solutions.

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Naveen Kumar

Fresher

CR & CDM trainer at Covalent comes from MNC with 12+ years of realtime experience. He is very knowledgeable and supportive. I must say this training makes you job-ready.

 
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Jai Vardhan

Fresher

I suggested this institute for CR & CDM because of experienced faculty and wide range of examples they provide for the better understanding of the subject. My favourite place for CR & CDM training, support by faculty pre and post course was awesome.

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Kadireni Mahesh

Clinical Research Programmer

It is the best training institute in Hyderabad. The faculty here is very supportive & imparts very good knowledge on Clinical Research & Clinical Data Management Training here works like a bridge to build up career and succeed.

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KUNAPAREDDY SWARNA

Fresher

I am fully satisfied with clinical Research and Clinical Data Management. The faculty is very much interactive to the students in clarifying each and every issue. This is the best institute for clinical research and data management. The faculty is very good and cooperative.

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