AI IN DECENTRALISED CLINICAL RESEARCH

₹999

₹1,499

Instructor: Dr Sriharan SLanguage: English

About the course

Foundations of Decentralised Clinical Research (DCR)

  1. Why Traditional Trials Are Failing & Rise of DCR
  2. Role of AI, LLMs & Digital Health in DCR
  3. Mapping a decentralised trial workflow
  4. Careers: DCT Coordinator, Clinical Research Associate (Remote)Consulting: Entry-level DCT projects with Swalife and Swalife Clinical & Evidence Prompt Studio

AI-Driven Study Design for Decentralised Trials

  1. Study types: Interventional vs Observational vs RWE
  2. AI-assisted protocol design & feasibility
  3. AI-generated decentralised study protocol
  4. Careers: Study Designer, Clinical Data Planner, Consulting: Protocol design services and Swalife Clinical & Evidence Prompt Studio

Digital Patient Recruitment & Retention Using AI

  1. Challenges in patient recruitment
  2. AI-based patient identification & eligibility logic
  3. Hands-on: Recruitment strategy design and AI-assisted patient recruitment plan
  4. Careers: Patient Engagement Specialist, Consulting: Recruitment optimization services and Swalife Clinical & Evidence Prompt Studio

AI in Remote Monitoring & Digital Endpoints

  1. Wearables, apps & digital biomarkers
  2. AI for continuous health data interpretation
  3. Digital endpoints for a clinical study
  4. Careers: Digital Clinical Scientist, Consulting: Remote monitoring advisory and Swalife Clinical & Evidence Prompt Studio

AI in Data Collection, Cleaning & Integration

  1. Decentralised data sources & challenges
  2. AI-assisted data validation & preprocessing
  3. Cleaned & annotated trial dataset
  4. Careers: Clinical Data Analyst, Consulting: Data pipeline setup for DCTs and Swalife Clinical & Evidence Prompt Studio

AI-Driven Statistical Analysis & Interim Insights

  1. Adaptive trials & real-time analysis
  2. AI-assisted biostatistics & trend detection
  3. Interim analysis report
  4. Careers: Clinical Data Scientist and Consulting: Interim analysis & reporting and Swalife Clinical & Evidence Prompt Studio

AI in Safety Monitoring & Risk-Based Oversight

  1. Safety challenges in decentralised trials
  2. AI-enabled safety signal detection
  3.  Risk-based safety monitoring plan
  4. Careers: Safety Scientist, Risk Monitor, Consulting: Safety monitoring services and Swalife Clinical & Evidence Prompt Studio

AI for Regulatory Compliance in DCR

  1. Regulatory expectations (ICH-GCP, FDA, EMA)
  2. AI-assisted documentation & audit readiness
  3. Compliance checklist generation and Regulatory justification for DCT
  4. Careers: Clinical Regulatory Specialist, Consulting: Compliance advisory for DCTs and Swalife Clinical & Evidence Prompt Studio

AI in Real-World Evidence (RWE) & Observational Studies

  1. RWE vs clinical trials
  2. AI-based evidence generation & bias control
  3. RWE study report
  4. Careers: RWE Analyst, Consulting: Evidence generation services and Swalife Clinical & Evidence Prompt Studio

AI-Assisted Clinical Study Reports (CSR)

  1. Structure & expectations of CSRs
  2. AI-assisted narrative & table generation
  3. Hands-on: Mini CSR for decentralised study
  4. Careers: Medical Writer (Clinical), Consulting: CSR & medical writing services and Swalife Clinical & Evidence Prompt Studio

AI in Inspection Readiness & Trial Quality

  1. Remote audits & inspections
  2. AI-based quality risk management
  3. Inspection readiness dossier
  4. Careers: Quality & Compliance Lead, Consulting: Trial quality audits and Swalife Clinical & Evidence Prompt Studio

AI-Driven DCR Leadership & Consulting Mastery

  1. End-to-end DCR program leadership
  2. AI-enabled CRO & consulting models
  3. Full decentralised clinical study design
  4. Careers: Head of DCT / Global Clinical Operations, Consulting: Swalife consultant onboarding & revenue sharing and Swalife Clinical & Evidence Prompt Studio

India’s first AI-native, decentralised clinical research education + execution + consulting ecosystem

Syllabus

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