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Courses

Clinical Research

Protocol &Study Design basics
  • Protocol objectives, endpoints, inclusion/exclusion criteria
  • Study phases (I–IV), randomisation, blinding, control groups
  • Ethical approval (IRB/IEC) and informed consent
Clinical Trial Operations
  • Site initiation, subject recruitment, screening, enrolment, follow-up
  • Visit schedules, CRF/EDC completion, source documentation
  • Trial conduct support: deviations, amendments, participant retention
Data Management in Clinical Research
  • Data collection standards, CRF design and annotations
  • Query management, data cleaning, data reconciliation
  • Database lock activities and data quality checks

Statistical Programming

Standards & Dataset Programming
  • CDISC implementation (CDASH/SDTM/ADaM), dataset build, QC, traceability
  • SDTM/ADaM programming and key derivations
Analysis & Reporting Outputs
  • TLF programming for safety, efficacy, and complex outputs
  • Interim/ad hoc analyses, PK/PD outputs, formatted reports
Submission & Documentation
  • aCRF, Define.xml/Define.pdf, patient profiles
  • Specs, derivation documents, metadata consistency
Quality Control & Reconciliation
  • Independent QC, validation, discrepancy tracking
  • Cross-domain checks, missing data, outliers, consistency review
Programming Governance & Automation
  • SAS macros, automation, reusable templates, code optimization
  • SOPs, standards, version control, audit readiness
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CDISC Standards (SDTM, ADaM& TLF)

CDISC Standards & Models
  • Standardises clinical trial data for analysis and submission
  • Core outputs: SDTM, ADaM, and TLFs
Dataset Design, Derivations & Metadata
  • SDTM domains, identifiers, timing variables, and domain consistency
  • ADaM datasets and derivations such as baseline, change, visits, and population flags
TLF Programming & Deliverables
  • Tables, listings, and figures built from ADaM for CSR-ready reporting
  • Standardised output formatting, titles, footnotes, pagination, and RTF/PDF outputs

Biostatistics

Statistical Foundations
  • Population vs sample, parameters vs statistics
  • Variable types, measurement scales, distributions, variability
Descriptive Statistics & Estimation
  • Mean, median, mode, SD, variance, IQR
  • Data interpretation using histograms, boxplots, scatter plots
  • Point estimates, confidence intervals, margin of error
Hypothesis Testing & Common Methods
  • Null vs alternative hypothesis, p-values, α, Type I/II error, power
  • One-tailed vs two-tailed tests
Regression, Association & Survival Analysis
  • Correlation and regression basics, including logistic regression
  • Time-to-event analysis, Kaplan–Meier curves, log-rank test, hazard ratio
Clinical Trial Biostatistics & Bias
  • Randomisation, blinding, trial populations, endpoints
  • Missing data concepts, multiple testing, confounding, bias
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Therapeutic Standards

Therapeutic Area & Endpoint Knowledge
  • Disease background, unmet need, standard of care, and treatment guidelines
  • Therapeutic-specific endpoints, baseline rules, windowing, and responder definitions
Therapeutic Standards & Safety Awareness
  • Therapeutic Standards & Safety Awareness
  • Therapeutic Standards & Safety Awareness
Coding, Reporting & Cross-Functional Alignment
  • MedDRA and WHO Drug/ATC coding for consistent reporting and pooled analysis
  • Therapeutic-area reporting conventions and terminology consistency across outputs

Pre- Clinical Research

Study Design & Experimental Models
  • Hypothesis, endpoints, controls, dose levels, and timepoints
  • Fit-for-purpose model selection: in-vitro, ex-vivo, in-vivo
Preclinical Research & Lab Methods
  • In-vitro assays, cell culture, dose–response testing
  • Bioanalytical and lab techniques, sample handling, QC controls
Pharmacology, Safety & ADME
  • Target/pathway understanding and biomarker strategy
  • Toxicology concepts and non-clinical safety endpoints
Data, Compliance & Translation
  • Documentation, SOP adherence, reproducibility, and basic statistics
  • Animal ethics, 3Rs, biosafety, and chemical safety
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e-Stats_logo_with_DNA_icon12-removebg-preview
e-Stats provides expert statistical programming and biostatistics services for clinical trials, ensuring precise, fast, and compliant support for life sciences, pharma, biotech, and healthcare.
Facebook-f X-twitter Youtube Icon-pinterest

Quick Link

Important Links

Contact Info

+91 62933 37999

contact@e-stats.in

8th Floor, G block, Gopalan Global Axis, near Satya Sai Hospital Metro Station, Bengaluru

Copyright © 2026 e-stats  All Rights Reserved.