Informed Study Design and Endpoint Analysis—Clinical Biostatistics
Determine your drug efficacy and effectiveness with expert statistical analysis of your clinical study data with Altasciences’ trusted biostatisticians.
Biostatistics is necessary for all investigational drug development programs to determine the efficacy and effectiveness of studies using statistical analysis. This includes the study designs, study conduct, determining the most effective data collection points, and determining how analysis and reporting should be performed.
Altasciences has experience across a wide range of therapeutic areas and all phases of research and development. Our dedicated team of biostatisticians focuses on delivering accurate outputs at all levels of support, from protocol design, calculation of sample sizes, power calculations, and/or the production of study randomization to study-level analysis of Tables, Listings, and Figures (TLFs).
We prioritize meeting timelines without compromising accuracy. We offer our expertise on a per-project or full-time equivalent (FTE) basis to meet your specific needs.
Clinical Trial Biostatistics Solution
Altasciences has services across setup, analysis, and reporting.
Study Set Up
Study Design and Endpoint Development Guidance: Expert guidance to shape your study design and define meaningful endpoints
Power Calculations: Additional support to optimize study design and sample size selection through power calculations
CRF Review: Thorough review of case report forms (CRFs) to ensure accurate and relevant data collection
Statistical Consulting: Personalized consultation to address your statistical concerns and queries
Sample Size Estimations and Randomization Schemes: Rigorous calculations to determine optimal sample sizes and randomization plans
Statistical Analysis Plan with Mock Tables, Listings, and Figures (TLFs): Comprehensive plans including mock visuals for clear representation of results
Study Reporting
Data Review Sessions: Collaborative sessions to review and refine data throughout the project
SAS® Programming and Validation of Results: Programming and validation processes to ensure accurate and reliable results
Statistical Analyses and Appendices (TLFs) for Clinical Study Reports: In-depth analyses and clear visual representations for comprehensive clinical study reports
Derived Analysis Data Sets: Creation of specialized datasets to support advanced analyses
CDISC-Compliant Data Sets: Ensuring data sets adhere to Clinical Data Interchange Standards Consortium (CDISC) standards
FDA Submission-Ready Package: Creating your FDA submission package (TLFs, define.xml/.pdf, aCRF, reviewers’ guides)
CDISC Expertise
Altasciences is an active member and registered solutions provider for CDISC. We stay ahead of industry standards, applying CDISC data standards to enhance the quality of clinical research.
Consult our issue of The Altascientist which explores CDISC data standards.
Our CDISC services include:
CDISC-Compliant SDTM Datasets: Legacy study data and ongoing trial data prepared for submission
CDASH-Compliant CRFs: Design and implementation of CRFs for both paper-based and electronic data capture (EDC) trials
Analysis Data Model (ADaM) Datasets: Creation of CDISC-compliant datasets for statistical analysis
Full CDISC Services: Gap analysis, annotated case report forms, trial design compliant datasets, Define.xml and Define.pdf file generation, OpenCDISC and Pinnacle 21 utilization, and strategic consulting
Biostatistics CRO
Pharmaceutical and biotechnology companies partner with us for our collaborative approach and the knowledge our biostatistics experts transfer to their teams.
Expert Knowledge: Altasciences’ has evolved over the last 30 years, drawing upon our statistical consultancy team's extensive industry expertise and reputation.
A Range of Services: Altasciences offers comprehensive support, ranging from tailored biostatistical consultancy for protocol design, sample size calculation, power analysis, and study randomization, to in-depth analysis at the study level, including Tables, Listings, and Figures. We also extend our expertise to provide guidance and assistance for nonclinical studies, ensuring alignment with study objectives.
Therapeutic Experience: With expertise spanning diverse therapeutic areas and all phases of research and development, we support your drug development project. Our commitment to scientific principles ensures the generation of high-quality data and complete nonclinical and clinical trial reporting for your regulatory submission.
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Advancing your drug candidate smoothly to proof of concept is what we do best.