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SAS Course Content

Statistical Analysis System, is a software suite developed by SAS Institute for advanced analytics, business intelligencedata management, and predictive analytics. It is the largest market-share holder for advanced analytics.
Professional training on Clinical Research, CDSIC SDTM and SAS
for all life science graduates.
Training Featurs :

  1. Training is designed as per the Industry Requirements in the market.
  2. Training is provided by the real time faculty with a project.
  3. Duration: 2 months (120 hours).
  4. Training includes Study material, Project and 100%* Placement support.
  5. Training is available both off line (classroom) and online.

Clinical Research

  1. Drug Discovery and Development Process
  2. Introduction to Clinical Research
  3. Ethics considerations on Clinical Research
  4. Ethics Committee and IRB/IEC
  5. Overview of ICH-GCP Guidelines
  6. ICMR Guidelines
  7. Essential Documents
  8. Protocol Design
  9. Clinical Trial Design
  10. Sponsor Responsibilities
  11. Responsibilities of Investigator
  12. Site Initiation Visit (SIV)
  13. Drug Accountability
  14. New Drug Application Submission (NDA)
  15. Scheduled-Y Application
  16. Study Coordinators (CRA/CRC)
  17. Site Close-out
  18. 21 CFR PART11

sasSDTM
(Study Data Tabulation Model)

    • What is CDISC and Standards?
    • What is SDTM?
    • Types of variables and core values
    • Basic structure of the domains
    • Brief Explanation about all the domains in SDTM IG
    • Difference between SDTM IG 3.1.2v and  3.1.3v
    • Standard domains vs. custom domains
    • Controlled terminology and QS scales
    • A Real time Practice on SDTM Mapping Specification.
    • What is CRF annotation (Practice on aCRF)
    • Generating the standard CRT Tables by SAS.
    • MedDRA and  WHO DRUG standards
    • Introduction to OpenCDISC and Report?
    • Generating SAS and .XPT files?
    • What is define.xml and define.pdf?
    • What is Reviewers guide?
    • Required Documents for FDA submission