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Mandatory Training & Certifications (For Biostatisticians & Programmers)
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ICH-E3
An international guideline that defines the structure and content of Clinical Study Reports (CSRs), with biostatisticians playing a key role in study design, Statistical Analysis Plan (SAP), analysis datasets, statistical analyses, tables, listings, figures (TLFs), interpretation of results, and ensuring regulatory-compliant reporting.
ICH-E9
An international guideline that establishes the statistical principles for designing, conducting, analyzing, and interpreting clinical trials, ensuring that study results are scientifically valid, unbiased, and suitable for regulatory decision-making.
ICH-E9 R1
An international guideline addendum that introduces the Estimand Framework, providing a structured approach to defining treatment effects and handling intercurrent events to ensure that clinical trial objectives, statistical analyses, and interpretations are scientifically aligned and regulatory compliant.
FDA Guidance: Adaptive Designs
Provides recommendations on the planning, conduct, analysis, and regulatory considerations for clinical trials that allow prospectively planned modifications based on interim data while maintaining study validity and integrity.
FDA Guidance: Multiple Endpoints
Outlines statistical methods for controlling the Type I error rate when evaluating multiple primary, secondary, or exploratory endpoints in clinical trials.
FDA Guidance: Interim Analyses
Provides recommendations for planning, conducting, and interpreting interim analyses, including maintaining trial integrity, controlling statistical bias, and supporting data-driven decisions such as early stopping or sample size adjustments.
FDA Guidance on Data Monitoring Committees (DMC/DSMB)
Provides recommendations on the establishment, responsibilities, and statistical role of Independent Data Monitoring Committees (IDMC/DSMBs) in safeguarding participant safety, monitoring trial conduct, reviewing interim data, and making recommendations on trial continuation, modification, or termination.
CDISC SDTM
A CDISC standard that defines the structure, organization, and formatting of clinical trial data for regulatory submissions, enabling consistent, standardized, and FDA/PMDA-compliant data exchange and review.
CDISC ADaM 1.2 & 1.3
A CDISC standard for creating analysis-ready datasets that support statistical analyses, regulatory submissions, and complete traceability from SDTM to Tables, Listings, and Figures (TLFs).
Small-Sample / Early-Phase Design Methods
Statistical methods used in Phase I and early Phase II clinical trials to optimize dose selection, evaluate safety and preliminary efficacy, and make efficient decisions with limited sample sizes while maintaining scientific validity.
ICH-E10
An international guideline that provides recommendations on the selection and use of appropriate control groups (placebo, active, dose-response, no-treatment, and historical controls) to ensure the ethical conduct and scientific validity of clinical trials.
ICH-E17
An international guideline that provides recommendations for the design, conduct, statistical planning, and analysis of multi-regional clinical trials (MRCTs) to support global regulatory submissions and ensure consistent treatment effects across different regions and populations.
FDA Guidance & RWE
Missing data in Clinical Trials and Statistical Considerations for clinical trials during disruptions
ISO 14155
International standard for the design, conduct, monitoring, and statistical evaluation of medical device clinical investigations.
Eligibility
- Candidates Enrolled Into Specific Programs Have Free Access As A Part Of Training & Internship Curriculum
- Graduates & Post-Graduates from Pharmacy, Life Sciences, Science, Biotechnology, Microbiology etc. Looking To Build A Career In Clinical Research
- Anyone Who Wishes To be Regulatory Ready
E- Certification Badge
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