Biostatistics

Advance your study with expert study design, optimized submission strategy, and comprehensive publication plans.

Delivering superior statistical services to define your success

Premier Research’s Biostatistics Department offers full programming and data analysis to deliver laser-focused insights at every stage of your trial and, ultimately, assure regulatory compliance. Our veteran biostatistics professionals work closely with you, pairing technical expertise with an average of 11 years of industry experience to rigorously transform your data into insights. They understand your data must be clean and comprehensive and be analyzed and presented flawlessly in order to support trial success. Premier offers:

International staff who optimize regulatory-compliant and cost-effective methods of collecting, analyzing, and presenting both interim and final analysis results
Comprehensive clinical development planning from protocol design and sample size calculation through clinical study report (CSR) writing and review
Direct integration of biostatistics activities throughout the full project plan, including database design and setup and report development
Advanced knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards and requirements to ensure new drug application (NDA) submission-ready data
Extensive proficiency in data and safety monitoring board (DSMB) output, interim analysis, and investigational new drug (IND) safety updates
Deep and varied regulatory filing experience spanning dermatology, a variety of rare/orphan diseases, oncology, central nervous system, gastrointestinal, and acute otitis media

SERVICES INCLUDE

Study design and protocol development
Sample size estimation
Statistical analysis plans
DSMB and interim analyses
DSMB participation
Adaptive study designs
CDISC-compliant datasets and documentation
Cross-functional review of data
Statistical tables, listings, and figures
CSR review
Integrated summaries (ISS/ISE) for regulatory submission
Exploratory analyses
- Manuscripts
- Publications
- Marketing support

SERVICES INCLUDE

Study design and protocol development
Sample size estimation
Statistical analysis plans
DSMB and interim analyses
DSMB participation
Adaptive study designs
CDISC-compliant datasets and documentation
Cross-functional review of data
Statistical tables, listings, and figures
CSR review
Integrated summaries (ISS/ISE) for regulatory submission
Exploratory analyses
- Manuscripts
- Publications
- Marketing support

Our statistics teams have worked on hundreds of individual studies, across Phases 1-4, many of which have been included in NDA filings. We have also planned and programmed the integrated analyses for many of these NDA filings (ISS/ISE work). Core service offerings include:

Statistical analysis plans
Statistical programming including rigorous quality control
Table, listing, and graph generation
CDISC dataset generation and documentation
Regulatory statistical strategy, integrated analysis and data submission, and follow-up support

We have experience entering the ISS/ISE process at every stage imaginable — from Phase 1 through Phase 3, where we have analyzed each individual study throughout the development cycle, to integrating an entire program of studies that have already been completed prior to our involvement.

The most innovative trials

The most innovative trials — such as adaptive design studies and trials for advanced therapies — face unique challenges. We are experienced in the most current biostatistical methodologies to meet these demands by providing interim analyses, integrating analyses from multiple studies, and analyzing data gathered in challenging environments. Our expertise covers:

Multiple imputation
Tipping point analysis
Adaptive designs, including basket and umbrella studies
Real-world data and real-world evidence

Oversight and continuity are vital to successful trial outcomes. That’s why, at Premier, a lead statistician oversees the statistical and programming services for each study, working closely with the entire study team to deliver precisely what you need. We offer:

An average of 11 years of industry experience across multiple therapeutic areas and phases, major submissions, and agency meetings
Technical expertise in biostatistical programming and a broad range of applied statistical methods
Strong consulting experience to handle your submission strategy, publication plans, and exploratory analyses
A record of successful performance on large, complex projects, providing assurance of our ability to meet the challenges of your development program
Hands-on skill as SAS programmers

PREMIER PERSPECTIVE

Statistical considerations for FDA COVID-19 guidance

The Statistics Department at Premier Research has committed to highlighting specific and necessary actionable considerations that directly address the latest FDA recommendations. These considerations call attention to some general actions required to ensure the operational integrity and scientific robustness of clinical trials going forward.

Adaptive trial designs in early oncology

With the emergence of precision medicine, we are seeing a shift in how early-phase oncology trials are conducted, including a growing number of Phase 1 trials reporting preliminary response rates. This shift is due in part to an increase in adaptive trial designs that seek to limit the number of patients exposed to ineffective doses or treatments while accelerating the timeline to the detection of efficacy signals.

DOWNLOAD

Related Services

Biostatistics is part of a wide range of integrated biometrics offerings that include IRT, medical writing, and study design. Follow the links below to learn more about how clients have benefited from our specialized expertise.