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 is committed to driving excellence 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.
We prioritize meeting timelines without ever 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 for every part of your journey:
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, Figures, and Listings (TFLs): : 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: Robust 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: : Packaging your data for submission with confidence.
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.
Comprehensive 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
Top pharmaceutical and biotechnology companies rely on us due to our personalized approach, fostering enduring relationships and facilitating the transfer of our experts' biostatistics knowledge to our clients.
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, Altasciences is equipped to support your drug development journey. Our commitment to scientific principles ensures the generation of high-quality data and comprehensive nonclinical and clinical trial reporting, bolstering your regulatory submission.
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Advancing your drug candidate smoothly to proof of concept is what we do best.