Clin Infotech

Teacher Name

35 Days

Explore A Rewarding Career In The World Of

Clinical Research:

About This Course:

To cater to this special category of  Clinical Research professionals, Clininfotech has formulated a comprehensive intensive training program that encompasses all facets of the Clinical Research and related fields. Under this program, the selected participants will be given adequate hands-on Experience On important Clincal Softwares; The Learners Will be providing the Hands on Experience work with live scenarios in the agile environment; make interactive

Consequent to this scenario, a large number of clinical research organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management, clinical research consultancies, KPOs etc. This has created a demand for skilled workforce in the clinical research industry.

This course will provide extensive training in the niche domain of clinical research. It incorporates end-to-end theoretical & practical training.

Program Structure:

Modules:

  • Clinical Research

  • Pharmacovigilance

  • Clinical Data Mangement

  • Regulatory Affairs

  • Medical Coding

Live Project Description

Deploy and Deliver Immersive Learning Experience on the Clinical Research Technology that is being Skilled.

Unlock the potential of hands-on learning. Drive a hassle-free, hands-on learning experience that centers around your technology ecosystem they need for success. By unifying our live-virtual sandbox labs with a virtual classroom environment, delivery of hands-on learning becomes easy, engaging, and scalable.

  • Review and understand study protocol and the study timelines
  • Accurately review case report form (CRF) for completeness, accuracy and consistency in accordance with all applicable procedures.
  • Create data listings for manual checks
  • Create data listings from CRF data
  • Responsible for various other activities including testing of Validation Procedure, Database testing and handling discrepancies in Database as per protocol.
  • Perform external checks to handle manual discrepancies and action the same.
  • Performing User Acceptance Test. (Using Edit Check Specifications and other Checklist’s)
  • Issued and managed clinical data queries to closure.
  • SAE Reconciliation.
  • Proficient in working on Oracle Clinical Database and EDC/RDC tools.
  • Basic knowledge in Inform.
  • To freeze and lock data as appropriate in time for statistical review blinded interim quality review, interim and final database lock.
  • Build data extract views in OC well versed knowledge of FDAand ICH regulations applicable to the design, analysis and reporting of clinical trials.
  • Good comprehension of FDAguidelines,  ICH-GCP Guideline esp. E3, E6, E9
  • Dedicated and trustworthy team worker with excellent analytical skills.
  • Highly energetic person committed to achieve goals set forth.
  • Case Processing, Narrative Writing, Exposure to Spontaneous Cases, Literature Cases, Clinical Trial Cases, Legal Cases

Eligibility

  • The minimum eligibility criteria for Post-Graduate Diploma in Clinical Research Course would include either of the following:

    – Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
    – Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
    – Any degree in Pharmacy / Pharmaceutical Sciences
    – Any degree in Chemistry / Biostatistics / Bioinformatics
    – Any degree in Nursing / Allied Health.
    – Students in their final year of graduation for the above courses are also eligible to apply.
    Please contact our admission Executives / counsellor to discuss If you lack the above mentioned educational Qualification you may still be eligible to apply upon recommendation of your supervisor to clarify your Doubts.

Why Clininfotech?

Clin infotech Benefits

  • Hands on Project Experience on the Leading Softwares

  • Live Project Training     

  • Real Time case studies to practice

  • Free Technical Support after Course Completion

  • LMS Access

  • LAB Facility 

  • Internship With Live Projects

100% Guaranteed Job Support

  •   We send you for interviews till you get a job

  • We get your Resume Ready to attend interviews  

  • Interview Preparation Support
  • Write Technical Exams before attending Interviews
  • Mock Interviews
  • Pre-Requisite: Pharmacy, Dental Medical and Life Sciences Graduates.
  • Interview Questions with Answers

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Assignments & Projects.

Certificate would be awarded at the end of the program by Gratisol Labs. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.

List of the Certification Courses:

  • Advance Certification In Clinical Research And Pharmacovigilance – (Give navigation Link to the page)
  • Advance Certification In Pharmacovigilance and Clinical Data Mnagement
  • Advance Certification In Clinical Research and Clinical Data Management
  • Advance Certification In Pharmacovigilance and Regulatory Affairs

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