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Biostatistics

Biotrial boasts a team of experienced and proficient Biostatisticians and SAS Programmers who offer exceptional statistical services to sponsors. Biotrial is fully equipped to manage projects from Phase I to Phase IV and surveys that adhere to regulatory requirements.

Our Biostatistics team offers comprehensive support to clients throughout the entirety of the project analysis process, from the selection of trial design and methodology, to the delivery of final outputs for submission of trial results.

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

CDISC ADaM

Biotrial has been offering ADaM deliverables to sponsors since 2009. All processes and templates are CDISC-compliant.

ADaM compliance is managed by the internal CDISC governance group who participates in regular CDISC workshops and is in charge of maintaining processes and tools as well as training Biotrial staff.

Our team is experienced in adhering to Biotrial’s CDISC standards. Additionally, we collaborate with various sponsors who have their own CDISC implementation.

ADaM Datasets
Define.xml and Reviewer’s Guide
Bioresearch Monitoring (BIMO) package
For preclinical projects: SEND package

DSMB / IDMC SUPPORT

When a protocol requires regular data reviews for safety or efficacy monitoring or futility analysis, Biotrial’s Biostatistics group can provide the expertise needed to perform the required analyses in an independent manner.

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
Dedicated Analysis Plan
Kick-off
Deliverables programming
Meeting materials – open and closed sessions
Meeting participation – voting or non-voting member

TEAM

Biotrial Biostatisticians

In charge of all biostatistics activities on a given project, oversee all programming activities.

SAS Programmers

In charge of the programming of the ADaM datasets and statistical deliverables including TFLs and CDISC documentation

Independent Biostatisticians

Involved on projects where an unblinded service is required in parallel with the main analysis, e.g. for Interim Analyses or DSMB

ADaM & SEND Experts

Global oversight for all ADaM activities: Regulatory monitoring, train team members, interact with sponsor counterparts, maintain Biotrial tools

Related Information

EDC Data Management Pharmacokinetics Medical Writing Preclinical Clinical Core Lab Bioanalysis