Clinical Research, SAS, Data Management, Pharmacovigillance, Regulatory Affairs Hyderabad : Free Training
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  1. October 10th, 2012, 02:14 PM Post Count Number #1
    CLINSERVE12
    On probation
    Join Date
    October 10th, 2012
    Location
    HYDERABAD
    Posts
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    Clinical Research, SAS, Data Management, Pharmacovigillance, Regulatory Affairs Hyderabad : Free Training

    Hi All,

    Looking for career in clinical data management then call us on 8977927530

    clinserve, a non profit organisation provides services in the area of educational sector.

    As part of the services ,we offer “ FREE TRAINING IN CLINICAL RESEARCH,SAS,CLINICAL DATA MANAGEMENT, PHARMACOVIGILANCE AND REGULATORY AFFAIRS”.

    We are now focussing on training to generate great professionals in the mentioned sector.

    If any one interested ,please call us or drop a mail to

    Kiranmayi225@gmail.com or clinserve12@gmail.com

    We will cover all major topics as part our course curriculum.

    Components of Part I :
    Introduction to Clinical Research
    ** Basics of Clinical Trials & Clinical Research
    ** Terminologies & definition of Clinical Trials
    ** Types of Clinical research
    ** Phases of Clinical Research
    ** Good Clinical Practices
    ** Patient Recruitment
    ** Clinical Trial Statistics
    ** Bioavailability Studies
    ** Research Methodology
    ** Design of Experiments
    ** Clinical Trial Team
    ** Clinical Trial Regulatory Affairs
    ** Bioethics

    Drug Development Process.
    ** Drug discovery
    ** Preclinical testing
    ** Clinical Development

    History & Regulation in Clinical Research
    ICH -GCP Guidelines - International Conference of Harmonization
    ** The principles of ICH GCP
    ** Institutional Review Board/Independent Ethics Committee (IRB/IEC)
    ** Investigator
    ** Sponsor
    ** Clinical trial protocol and protocol amendment (s)
    ** Investigator's brochure
    ** Essential documents for the conduct of a Clinical trial

    SCHEDULE Y Drugs
    Preparations & Planning for Clinical Trials
    Essential Documentation in Clinical Research & Regulatory Submissions
    Clinical Research Operations and Clinical Research Monitoring.
    Regulatory Affairs, Good Clinical Practices and Ethics issues
    Responsibility of Clinical Research Professionals.
    21 CFR 11
    Introduction to CDISC & CDASH
    SDTM Implementation
    Informed Consent Form
    Protocol Development

    Components of Part II :
    Clinical Data Management
    Introduction to Databases.
    Data Management Plan
    Study Set Up.
    ( Electronic Data Capture.)
    CRF Design.(Paper)
    e- CRF Design
    Open Clinica (Theory and Practical)
    Overview to Major Clinical Databases like oracle clinical ,clintrial,Inform,Medrio,rave…etc.

    Components of Part III :
    SAS 9.2
    BASE/SAS
    SAS/STAT
    SAS/PROCEDURES
    SAS/ACCESS
    SAS/SQL
    SAS/GRAPH
    SAS/MACROS
    SAS ENTERPRISE GUIDE4.1
    Biostatistics for Clinical Trials
    Components of Part IV :
    Introduction to Pharmacovigilance
    Importance of pharmacovigilance
    Adverse Drug Reactions
    Regulatory in Pharmacovigilamnce
    ADR/causality Assessment
    Narrative writing

    Eligibility :
    All Life Science Graduates, Doctors, Medical Professionals, Pharmacists etc.
    B. Sc./ M. Sc. in Biotechnology, Microbiology, Genetics, Biochemistry or life sciences,M.B.B.S / B.D.S / B.A.M.S / B.H.M.S,B. Pharmacy/ M. Pharmacy, Graduates or Post Graduates in Nursing,B.E (BT) / B. Tech (BT)
    We will help you in resume preparation and interview preparation.
  2. January 11th, 2013, 01:23 PM Post Count Number #2
    clinserve
    On probation
    Join Date
    October 10th, 2012
    Location
    Hyderabad
    Posts
    1

    FREE JOB ORIENTED TRAINING IN CLINICAL REASEARCH SAS,CLINICALDATAMANGEMENT,PHARMACOVIGILANCE,REGULATORY AFFAIRS

    Clinserve, provides JOB ORIENTED PROFESSIONAL TRAINING in the area of CLINICAL RESEARCH.
    CLINSERVE offer “ PROFESSIONAL TRAINING IN CLINICAL RESEARCH, SAS, CLINICAL DATA MANAGEMENT, PHARMACOVIGILANCE "
    We will cover all major topics as part our course curriculum.

    Module I: CLINICAL RESEARCH
    Clinical Research Introduction
    Principles of Pharmacology & Drug Discovery & Development
    Research Methodology and Clinical Trials Designs
    Phases of Drug Development Process
    Terminologies & definition of Clinical Trials
    . Types of Clinical research
    • Phases of Clinical Research
    • Features of Clinical Trials
    • Good Clinical Trial Practices
    • Patient Recruitment
    • Clinical Trial Statistics
    • Bioavailability Studies
    • Research Methodology
    • Design of Experiments
    Good Clinical Practices
    Regulations in Clinical Research
    Clinical Trial At a Site
    Responsibility of Clinical Research Professionals
    Preparations & Planning for Clinical Trials
    Essential Documentation in Clinical Research & Regulatory Submissions
    Clinical Trials Project Planning & Management
    Study Start Up Process
    Clinical Monitoring Essentials
    Compliance, Auditing & Quality Control in Clinical Research
    Schedule Y Drugs
    Clinical Research Operations and Clinical Research Monitoring.
    Regulatory Affairs, Good Clinical Practices and Ethics issues
    21 CFR 11
    CDISC & CDASH
    Informed Consent Document (ICD)
    Protocol Development and amendment

    Module II: CLINICAL DATA MANAGEMENT (CDM)
    Elementary understanding of Clinical Data Management
    CRF Design
    CRF completion guidelines (CCG)
    Clinical Database Types of databases
    Electronic Data Capture
    e-CRF Design
    Tracking of Clinical data
    Data entry, review
    Identify/management of discrepancies
    Edit checking, data validation specifications
    User Acceptance Testing (UAT)
    QA,QC
    Hands on experience of OPEN CLINICA(End to End Data Management)
    Overview to Oracle Clinical
    Overview to Rave
    Overview to Inform
    Overview to Medrio
    computer System validation
    SQL (Structured Query Language)
    Study setup

    Module III: Pharmacovigilance
    Introduction to Pharmacovigilance
    Importance of pharmacovigilance
    Adverse Drug Reactions
    Regulatory in Pharmacovigilamnce
    ADR/causality Assessment
    Narrative writing
    Pharmacovigilance workflow using ADR DB.

    Module IV : SAS
    • SAS 9.2
    • SAS/BASE
    • SAS/STAT
    • SAS/PROCEDURES
    • SAS/ACCESS
    • SAS/SQL
    • SAS/GRAPH
    . SAS/MACROS
    . SAS EG

    Contact :
    Clinserve
    Balaji Nagar
    Kukatpally
    Near Kalyan Jewellers
    Hyderabad-72

    call : 8977927530
    www.clinserve.org
    mail : clinserve12@gmail.com