🧬 For Pharmacy, Biotech & Life Sciences Colleges

Applied CDISC Standards & Clinical SAS Programming

A ready-to-deploy 45-hour academic curriculum bridging pharmacology and statistical data programming. Students build real FDA-compliant SDTM, ADaM, and TLF deliverables, with zero preparation burden on your faculty.

📥 Download Course Syllabus & BOS Proposal (PDF) 📅 Book 15-Min Department Briefing

📦 Complete Syllabus Pack 🎓 Co-Branded Certs 🧠 Interactive Practice Coach

Why Life Sciences Departments Partner With Us

Global CROs and Pharmaceutical sponsors require entry-level statistical programmers to have hands-on CDISC experience. This course directly satisfies industry hiring standards.

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Direct CRO & Pharma Placement

Prepares students for Statistical Programmer, Clinical Data Analyst, and Biometrics roles at sponsors like Novartis, Pfizer, IQVIA, and Parexel.

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Real Protocol & eCRF Data

Students work on realistic multi-center clinical trials, mapping raw EDC data into Demographics, Adverse Events, Lab tests, and Vital signs.

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Outcome-Based Education (OBE)

Complete Course Outcomes (COs), Program Outcomes (POs) mapping, and rubric templates ready for Board of Studies and accreditation audits.

45-Hour Unit-by-Unit Syllabus Structure

Modular architecture suitable for a 1-semester elective or an intensive 6-week bootcamp.

Unit 1: Clinical Trial Architecture, Protocols & Regulatory Environment

6 Hours (4 Theory + 2 Lab)

Phases of Clinical Trials (Phase I–IV) • Good Clinical Practice (GCP) • 21 CFR Part 11 Compliance • Study Protocol & Statistical Analysis Plan (SAP) Deconstruction • Electronic Data Capture (EDC) and Raw Case Report Form (CRF) Workflow.

Unit 2: CDISC SDTM (Study Data Tabulation Model) Implementation

12 Hours (6 Theory + 6 Lab)

CDISC SDTM v1.7 Domain Structure • General Classes (Events, Findings, Interventions) • Demographics (DM) and `YRDIF` Age Calculations • Adverse Events (AE) and MedDRA Coding Mapping • Vital Signs (VS) • Laboratory Data (LB) Standard Units • SDTM Validation Rules.

Unit 3: CDISC ADaM (Analysis Data Model) Derivations

15 Hours (6 Theory + 9 Lab)

ADaM Fundamental Principles • Subject-Level Analysis Dataset (ADSL) • Analysis Population Flags (`SAFFL`, `ITTFL`, `COMPLFL`) • Adverse Events Analysis (ADAE) • Basic Data Structure (BDS) • Baseline Flags (`ABLFL`) and Change from Baseline (`CHG`) • Treatment-Emergent Flags (`TRTEMFL`).

Unit 4: Regulatory TLFs (Tables, Listings & Figures) for CSRs

8 Hours (2 Theory + 6 Lab)

PROC REPORT Deep Dive for CSR Appendices • Demographic Baseline Summary Tables • Adverse Event Frequency Tables (SOC & PT breakdown) • Lab Shift Tables • Kaplan-Meier Efficacy Figures • Strict Regulatory Pagination and Formatting.

Unit 5: Capstone Project & Mock Regulatory Review

4 Hours (Comprehensive Lab)

End-to-End Clinical Deliverable: Students receive unstandardized raw EDC data, build DM/AE SDTM domains, derive ADSL/ADAE datasets, and generate a final publication-grade CSR safety table.

Zero-Burden Faculty Enablement Kit

We empower your professors with comprehensive teaching assets so no extensive re-training is required.

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Instructor Slide Decks

Complete, editable PowerPoint lecture slides with high-resolution visual flowcharts for each unit.

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Lab Exercises & Solutions

Ready-to-run SAS code templates, dirty raw datasets, and fully commented golden solution files.

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Question Bank & Viva Rubrics

Over 200+ multiple-choice questions, mid-term coding prompts, and technical viva assessment rubrics.

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24/7 Interactive Learning Coach

Instant doubt resolution and guided feedback for students, freeing professors from routine syntax troubleshooting.

Official Academic Request

Request Clinical SAS Syllabus & Campus Quote

Receive the complete 45-hour syllabus proposal (PDF) and schedule an academic demo for your department.