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Biostatistics

Biotrial’s team of seasoned Biostatisticians and SAS Programmers delivers unparalleled statistical services to sponsors, ensuring the integrity and reliability of clinical data. Our comprehensive expertise spans the entire spectrum of clinical trials, from Phase I to Phase IV, and regulatory surveys.

Our Biostatistics team seamlessly integrates into the clinical research process, providing support from trial design and methodology selection to the finalization of data analysis outputs for submission of trial results. Our expertise encompasses:

  • Charter Writing or Review: Collaborating with sponsors to craft or review DSMB/IDMC charters.
  • Dedicated Analysis Plan: Develop tailored analysis plans aligned with the study protocol and DSMB/IDMC guidelines.
  • Kick-off: Facilitating effective DSMB/IDMC kick-off meetings, providing an overview of the study, data analysis plan, and interim analysis schedule.
  • Deliverables Programming: Preparing comprehensive and timely statistical deliverables for DSMB/IDMC meetings, including interim analysis reports, safety summaries, and futility analysis findings.
  • Meeting Materials – Open and Closed Sessions: Generating high-quality meeting materials for both open and closed DSMB/IDMC sessions.
  • Meeting Participation – Voting or Non-Voting Member: Providing Biostatistics expertise as either a voting or non-voting member of DSMB/IDMC meetings, actively contributing to discussions and decisions.
Biotrial-biostatistics-Data-Management-sas

In addition to supporting the analysis of trial results, our group also assists sponsors with specific elements such as pooled analyses, IDMC/DSMB (Independent Data Monitoring Committee / Data Safety Monitoring Board) support, or methodology consulting.

Services

Our service offering covers the full portfolio required for clinical development projects.

  • Statistical Methodology
  • Sample Size Estimation
  • Statistical Section of Protocol
  • Randomization
  • Statistical Analysis Plan (SAP) writing
  • Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses
  • Regulatory Support
  • SDTM Mapping
  • Interim Analysis
  • Data Monitoring Committee support
  • Derived Data Sets following ADaM Standards
  • Statistical Results and Appendices (TFLs)
  • Statistical Reporting
  • Mixed models
  • Analysis with repeated measurements
  • Equivalence/non-inferiority analysis
  • Multiple Comparisons
  • Continuous Reassessment and Adaptive Protocols
  • Survival Analysis
  • Non-Parametric Analysis
  • Analysis of Categorical Data
  • Dose Proportionality and Steady State Analysis

Experience

Checking Data

CDISC ADaM

Biotrial is a trusted provider of CDISC ADaM deliverables, ensuring the seamless integration of clinical data into regulatory submissions. Our team of experienced professionals has been delivering CDISC-compliant ADaM since 2009, upholding the highest standards of accuracy, consistency, and regulatory readiness.

Unwavering Commitment to CDISC Compliance

Biotrial’s internal CDISC governance group oversees our commitment to CDISC compliance, actively participating in regular workshops and continuously refining our processes and tools. This dedication ensures that our deliverables meet the latest CDISC standards and regulatory requirements.

Expertise in Multiple CDISC Implementation Scenarios

Our team is adept at working with various sponsors, regardless of their specific CDISC implementation methodologies. We seamlessly integrate into their existing workflows, ensuring compatibility and adherence to their chosen CDISC standards.

ADaM Deliverables: A Comprehensive Suite for Regulatory Submissions

  • Standardized ADaM Datasets: We provide well-structured and standardized ADaM datasets that facilitate efficient analysis and regulatory submissions.
  • Define.xml and Reviewer’s Guide: We meticulously prepare Define.xml and Reviewer’s Guide documents, ensuring comprehensive metadata documentation and supporting regulatory review processes.
  • Bioresearch Monitoring (BIMO) Package: We create a comprehensive BIMO package, encompassing all data relevant to bioresearch monitoring activities.
  • SEND Package for Preclinical Projects: We generate a comprehensive SEND package specifically designed for preclinical studies, ensuring data harmonization and regulatory compliance.

DSMB / IDMC SUPPORT

When a protocol requires regular data reviews for safety or efficacy monitoring or futility analysis, Biotrial provides the expertise needed to perform the required analyses independently.

The scope here will be to provide the statistical deliverables needed for committee members to make sound decisions on the progress of a clinical trial.

  • Charter Writing or Review: Collaborating with sponsors to craft or review DSMB/IDMC charters.
  • Dedicated Analysis Plan: Developing tailored analysis plans aligned with the study protocol and DSMB/IDMC guidelines.
  • Kick-off: Facilitating effective DSMB/IDMC kick-off meetings, providing an overview of the study, data analysis plan, and interim analysis schedule.
  • Deliverables Programming: Preparing comprehensive and timely statistical deliverables for DSMB/IDMC meetings, including interim analysis reports, safety summaries, and futility analysis findings.
  • Meeting Materials – Open and Closed Sessions: Generating high-quality meeting materials for both open and closed DSMB/IDMC sessions.
  • Meeting Participation – Voting or Non-Voting Member: Providing Biostatistics expertise as either a voting or non-voting member of DSMB/IDMC meetings, actively contributing to discussions and decisions.

Our TEAM

Biotrial’s Biostatistics team is a cohesive unit of seasoned statisticians, SAS programmers, and ADaM experts, collectively dedicated to ensuring the integrity and reliability of clinical trial data. Our team members collaborate seamlessly to deliver comprehensive biostatistical services across the entire drug development spectrum.

Biotrial Biostatisticians

Biotrial Biostatisticians are the cornerstone of our team, overseeing all biostatistics activities on a given project. 

SAS Programmers

Our skilled SAS programmers are the engine behind our biostatistical analyses. They meticulously transform raw clinical trial data into standardized ADaM datasets, enabling efficient and accurate statistical modeling. 

Independent Biostatisticians

When unblinded analyses are required, our team of Independent Biostatisticians provides invaluable expertise. Their involvement ensures that key decision-making, such as interim analyses and DSMB recommendations, is conducted with the utmost objectivity and integrity.

ADaM & SEND Experts

Our ADaM & SEND Experts are the guardians of data harmonization and compliance. They ensure that all ADaM and SEND deliverables adhere to the latest CDISC guidelines, enabling seamless submissions.

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