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Clinical SAS Course Training

Clinical SAS refers to the application of SAS (Statistical Analysis System) in the pharmaceutical, biotechnology, and healthcare industries for clinical trial data analysis and reporting. It plays a crucial role in regulatory submissions to agencies like the FDA (U.S.), EMA (Europe), PMDA (Japan), and other global health authorities.

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Clinical SAS Course Training Upcoming Batches

Demo Date

10th Feb

Time

09:00 AM TO 10:00 AM

Program Duration:

45 day

Learning Format:

JOIP

Course Curriculum

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Clinical SAS Overview

Clinical SAS is used to manage, analyze, and report clinical trial data to ensure the safety and efficacy of drugs or medical devices. It helps in data cleaning, statistical analysis, and regulatory compliance.

KEY HIGHLIGHTS

Data Management & Cleaning

Handling raw clinical data and preparing it for analysis

Statistical Analysis

Applying various statistical procedures to analyze efficacy and safety

Generating Reports & Visualizations

Creating tables, listings, and figures (TLFs)

Regulatory Submissions

Formatting data as per CDISC (SDTM & ADaM) standards for FDA/EMA approval

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Comprehensive Training

Key Features

Skills Covered

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Exclusive Training

JOB ORIENTED INTENSIVE PROGRAM (JOIP)​

INTENSIVE & INTERNSHIP PROGRAM (I&I)

Pre Requisites for Clinical SAS

Course Curriculum

  • Overview of SAS in the Pharmaceutical Industry
  • Role of a Clinical SAS Programmer
  • Introduction to Clinical Trials & Phases (I-IV)
  • Understanding Case Report Forms (CRF)
  • Overview of Regulatory Guidelines (FDA, EMA, ICH, HIPAA)
  • Introduction to the SAS Environment
  • Data Step & PROC Step
  • Importing & Exporting Data (Excel, CSV, XML, SQL)
  • Data Cleaning & Missing Value Handling
  • Merging & Transforming Datasets
  • SAS Functions (Date, String, Numeric, Statistical)
  • Conditional Statements & Loops (IF-THEN-ELSE, DO, DO WHILE)
  • Understanding Clinical Trial Data (Demographics, Lab Data, Adverse Events)
  • Sorting, Filtering, and Transposing Clinical Datasets
  • Handling Missing & Incomplete Data
  • Data Validation & Quality Control Techniques
  • Introduction to SDTM & ADaM Standards
  • Descriptive Statistics – PROC MEANS, PROC FREQ, PROC UNIVARIATE
  • Inferential Statistics – T-tests, ANOVA, Chi-Square, Regression Models
  • Survival Analysis – Kaplan-Meier, Cox Proportional Hazard Model
  • Adverse Event Analysis – Identifying Drug Safety & Side Effects
  • Handling Large Clinical Datasets
  •  

Introduction to CDISC (Clinical Data Interchange Standards Consortium)

Study Data Tabulation Model (SDTM)

Creating SDTM Domains (DM, EX, AE, LB, VS)

Analysis Data Model (ADaM)

Creating ADaM Datasets (ADSL, ADAE, ADLB)

Metadata Preparation – Define.XML, SAS XPT Files

Validation with Pinnacle 21

  • Generating Tables, Listings, and Figures (TLFs)
  • Creating Clinical Reports using PROC REPORT & PROC TABULATE
  • Output Delivery System (ODS) – Exporting reports in Excel, PDF, RTF, HTML
  • Preparing Clinical Study Reports (CSR) for Submission
  • FDA Submission Process & Requirements
  • Introduction to SAS Macro Programming
  • Creating & Using Macro Variables
  • Writing Reusable Macro Programs
  • Automating Clinical Data Processing
  • End-to-End Clinical Trial Data Analysis Project
  • Working with Real Clinical Datasets (SDTM, ADaM)
  • Hands-on Regulatory Submission Workflow
  • Resume Building & Interview Preparation

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Testimonials

I recently took a Clinical SAS Training at the Quality Thoughts. It was very much coordinated and Class A in its presentation. The trainer was effective in his/her training. Thanks, QT.

Raj Sharma

The last training I attended was the Clinical SAS with my husband at Quality Thoughts. The training program, was very well organized and assisted a lot in our career advancements.

Menka Prakash

Last month I attended the Clinical SAS training program at Quality Thoughts. The quality of the training is, in my opinion, excellent. At this I must say that the trainer did a good job.

Saif Sayed

Recently I have attended the Clinical SAS training conducted by Quality Thoughts. The program was good and informative and the faculty was excellent and did a good job

Jasmine R

Key Facts Of Quality Thought

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50000+ Students Trained

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