CustomizeTraining

Who Should Attend?

B.Pharmacy, B.D.S, M.Pharmacy, B.Tech Bio-technology,
Graduates/Post-graduate Life Sciences (B.Sc/M.Sc in Micro Biology, Bio Technology, Zoology, Botany, Chemistry etc)

Over the last Two years, we have served several organizations and many students, and we consistently hear that our teaching methods and courses are superior to any other training our students have ever attended. Throughout over 2 years of business we have maintained a 100% satisfaction rate. Here are some of the reasons for our success.


Modules:

Foundation:

  • Drug Development Process/Drug Discovery Process
  • Overview on Clinical Research/ Principles of Clinical Research
  • ICH-GCP(Good Clinical Practice)
  • CRO (Contract Research Organization) Industry Overview
  • Regulatory Bodies and Guidelines
  • CDISC – SDTM

SAS Clinical Programming

  • SAS Foundation
  • Data Manipulation Techniques
  • SAS Advanced Topics (Proc/SQL, Macros)
  • Biostatistics Foundation
  • Statistical Considerations
  • Understanding Protocol, CRF, SAP, SOP,
  • Understanding Specifications and Mock Shells
  • Creation of Analysis datasets
  • Creation of TLG/TLF

Clinical Data Management

  • Clinical Data Management Foundation
  • CRF designing
  • Data Entry Process
  • Data Validation
  • Discrepancy Management
  • Database Designing
  • Database Lock/Freeze
  • Data Extract
  • Data Storage/Archival