CLINICAL RESEARCH TRAINING

CLINICAL RESEARCH TRAINING

CLINICAL RESEARCH TRAINING

Intelogik provides clinical research Online & Classroom Training course by excellent experienced IT professionals. Our trainer has good training experience so that best quality output will be delivered. All our faculty is dedicated so that we can complete your course as per the schedule given. we provide classes through clinical research online by using world class interactive system. We also give interview support & Technical support. We market your profile in USA, UK SINGAPORE, INDIA, and SOUTH AFRICA. We trouble shoot your problems both theoretically & practically during the Online & Classroom Training ,even after the course completion. After completion of your clinical research training we will help you to clear your interviews. We will give you 100% Satisfaction and We provide best quality real time online & Classroom training.

  • Class Room Training: Available
  • Online Training : Available
  • Corporate Training : Available
    • Project Management in Clinical Research
    • What is Clinical Research?
    • What is Protocol and role of Protocol

IN CLINICAL RESEARCH?

  • What is randomization and non randomization?
  • Prepare SAS analysis datasets, tables, listings and figures as per specifications.
  • Map and migrate legacy datasets into CDISC SDTM and ADaM standard datasets.
  • Co-ordinate with the client and US-team for clarity of specifications, data issues ,outlier etc
  • Preferably from the Clinical trials domain in the pharmaceutical or biotechnology industry
  • Knowledge/experience in CDISC-SDTM and Adam

 

WHICH IS PLAYING MAIN ROLE IN CLINICAL RESEARCH?

  • What is SOP (Standard Operating Procedure)
  • Role of DBMS team in Clinical Research
  • What is CDM (Clinical Data Management)?
  • Importance of CDM systems for data loading
  • What is SAP (Statistical Analysis Plan)?
  • Role of SAP in Clinical Research
  • SAS Work Flow in Clinical Research
  • Relation between SAS and DBMS
  • Interaction between SAS with CDMs for data access
  • Various report generation in Clinical Research

 

CLINICAL RESEARCH

  • Introduction on Clinical Trials
  • Drug Discovery & Development Process
  • Evolution of Ethics
    Institutional Review Board
    ICH-GCP, Regulatory Authorities of different Countries
  • Clinical Trail Team (with more emphasis on CRA & CRC responsibilities)

 

CLINICAL RESEARCH ASSOCIATE:

  • What is CRA
  • Preparing for the Study
  • Study Initiation
  • Study Monitoring
  • Adverse Events and Safety Monitoring
  • Recruitment, Retention and Compliance
  • Study Closeout
  • Audits
  • Errors, Misconduct and Frauds
  • Clinical Research Coordinator:
  • Planning Stages and Commencements of the study
  • Interaction with Sponsor
  • Interactions within the Institution
  • Role of Study Subjects
  • Data Management
  • Adverse Event

 

INVESTIGATIONAL AGENT MANAGEMENT

  • Informed Consent
  • Protocol
  • Investigators Broacher
  • Investigational Product
  • Case Report Forms
  • SOP’s
  • Essential Trail Documents
  • Audit
  • Clinical Research Terminology

 

If you want to know more about Clinical Research Training do not hesitate to call +91-7774892805 or mail us on contact@intelogik.com