About Biostatistics
Experienced statisticians for projects of all sizes
Our Biostatistics & Clinical Programming services include:
Experienced statisticians for projects of all sizes
Our Biostatistics and Clinical Programming Team has extensive industry experience in a variety of therapeutic areas, including extensive interactions with regulatory agencies, development support, strategy planning and expediting the approval process. We add value to study teams by bringing technical expertise to projects of all sizes, fr
Our Biostatistics and Clinical Programming Team has extensive industry experience in a variety of therapeutic areas, including extensive interactions with regulatory agencies, development support, strategy planning and expediting the approval process. We add value to study teams by bringing technical expertise to projects of all sizes, from small first-in-human trials to large multinational studies.
Our statisticians
Our Biostatistics & Clinical Programming services include:
Experienced statisticians for projects of all sizes
From the inception of a study to final reporting, statistical consultancy is key to a study design fit for purpose that meets all the study objectives and focuses on the endpoints alongside ICH compliance. Our statisticians offer experience in various study designs (including adaptive and Bayesian designs), sample size estimation, handli
From the inception of a study to final reporting, statistical consultancy is key to a study design fit for purpose that meets all the study objectives and focuses on the endpoints alongside ICH compliance. Our statisticians offer experience in various study designs (including adaptive and Bayesian designs), sample size estimation, handling of missing data and combining trials for ISSs and ISEs. This level of expertise is demonstrated through the development of the Statistical Analysis Plan (SAP) text and TFL shells which will describe the methods to be used to analyze, summarize and present the data. Our statisticians collaborate with medical writers and scientific experts to ensure the appropriate interpretation of study results.
Our Biostatistics & Clinical Programming services include:
Our Biostatistics & Clinical Programming services include:
Our Biostatistics & Clinical Programming services include:
- Statistical input to protocols and study design
- Sample size determination and power calculation
- Statistical Analysis Plans (SAP) and output shells
- Randomization schemes
- Support for Independent Data Monitoring Committees (IDMCs), Investigative New Drug (IND) safety updates and Safety Review Committees (SRCs)
- Interim analysis
- Input to abstracts,
- Statistical input to protocols and study design
- Sample size determination and power calculation
- Statistical Analysis Plans (SAP) and output shells
- Randomization schemes
- Support for Independent Data Monitoring Committees (IDMCs), Investigative New Drug (IND) safety updates and Safety Review Committees (SRCs)
- Interim analysis
- Input to abstracts, posters and publications including presentation-ready graphics and tables
- Submissions to Regulatory Authorities (ISS/ISE, post-submission support, rapid response)
- Analysis datasets and/or submission-ready datasets and supporting metadata following Clinical Data Interchange Standards Consortium (CDISC) standards
- Conversion of legacy data to CDISC standardized format
- Statistical tables, figures and listings (TFLs)
- Statistical input to Clinical Study Reports (CSRs)
- Statistical representation for regulatory submissions and meetings