Training Details

Accesing Data
Creating Data Structures
Managing Data
Generating Reports
Handling Errors

PROC Macro
PROC Report

Sample Size calculation
Types of Randomization and generation in SAS.
Protocol inputs: Pharmacokinetic and all Statistical sections
SAP (Statistical Analysis Plan) preparation
TFL (Table , Listing and Figures) shell creation
Safety and Efficacy analysis
Data handling, compilation, validation and analysis
How to review and interpret the results. How to find the reason for pass and fail studies.
QA/QC/Sponsor/Regulatory query response.
Types of study designs (crossover, parallel, replicate etc) and different statistical approaches.
Clinical study report preparation with conclusion
Some other important learning’s like: framing of PK time points, CRF annotation, LOCF and BOCF approach, flow of whole process, etc.
Different regulatory (USFDA, MHRA, ANVIZA, CANADA, CDISCO etc) and guidelines (ICH E3, ICHE6 and ICHE9) approach and knowledge.
SOP Inputs
Outlier, Outlier methods, re-dosing studies, two stage approaches etc.
Application of different and important Statistical methods:
Adaptive designs, Superiority and non-Inferiority approach, Parametric and non parametric tests, Odd ratio, Relative risk, Hazard ratio, Co-relation, Regression, Time series, Survival analysis, etc…
Introduction: Pre clinical and clinical research
Roles and responsibilities
Pharmacokinetic and Pharmacodynamic studies
Pre clinical trials (Toxicology and Pharmacology studies)
Phase I trials (PK/PD, Bioavailability & Bio-equivalence studies)
Core clinical trials (Phase I , II , III and IV studies)
Regulatory and ethical guidelines (like USFDA, MHRA, ANVIZA, DCGI, IND, NDA, ANDA etc and GCP, GMP, ICH, etc.)
Documentation in clinical trials (like what is ICF, CRF, IRB, DMC, Protocol, SOP, etc)
Different departments and wok profiles in CRO
Basic terminology and it’s usage like adverse events, concomitant medications, Demographic, vitals, etc
CRO Model (whole flow and process)

Notes: Module 1, 2 and 7 are free of cost

Value added Services

Certificate of confidence including all modules and SaSTAT

Interview preparation

Course materials will be provided by SaSTAT

100% Job assistance

Assistance to update resume to get job in SAS & Statistics

SaSTAT giving great opportunity to reduce your fee by using referal policy

Pay fees in installments

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