Frontier Science | Services

Biostatistics

High-quality biostatistical analysis for clinical trials

Once a clinical trial database is clean and locked, robust and correct statistical analysis is the next building block for study success. At Frontier Science Scotland, our experienced team of programmers, data analysts and statisticians provide academic research, regulatory submission and consultancy support for studies of all shapes and sizes. By tapping into our biostatistical expertise, you can be sure that the correct methods will be applied, resulting in accurate, interpretable results.

We predominantly use SAS for our statistical analyses, but our team is also experienced in R and Stata.

Find the answers to your research questions with ease by getting in touch with us today.

FUNCTIONAL SERVICE PROVISION (FSP) FOR BIOSTATISTICS

Our 17-strong biostatistics function (statisticians and statistical programmers) is flexible enough to mould to your needs. We can provide the full suite of statistical analysis services, or you can cherry-pick individual elements. What always stays the same is our commitment to upholding regulatory standards and providing customers with a seamless working relationship.

Thanks to our FSP approach, you might employ FSS to fill short-term gaps in your in-house capacity for a specific project, task us with creating just one CDISC dataset or use our expertise for sample size calculations and contribution to statistical analysis plans.

Get in touch with us to find out how our team can work with yours.

Our Biostatistics services

SAMPLE SIZE CALCULATIONS

Ensure your clinical trial is valid by getting us to take care of your sample size / power calculations.

INDEPENDENT DATA MONITORING COMMITTEE

We have worked on both blinded and unblinded regulatory studies. If independence is what you need to give your trial additional gravitas and meet regulatory requirements, you’ll find it at FSS.

ANALYSES FOR RESEARCH PROJECT

Once an initial regulated study is completed and its associated data becomes available for other uses, we contribute to providing the data and assist with further analyses subject to the appropriate data application. We can also help support you with your own data and research question, whether that be within a trial, or perhaps an observational study.

STATISTICS ANALYSIS PLAN (SAP)

Selecting the right statistical method is critical for your clinical trial. Thanks to the size and diversity of our team, we’ve been involved in a huge range of studies, so we can help you avoid common problems.  We can create statistical analysis plans that meet your required specifications. This could include the details of calculations, layouts and dummy tables.

REGULATORY SUBMISSIONS

We’ve worked to CDISC standards for years, so we’re perfectly positioned to offer CDISC-mapping consultancy and management services for regulatory submissions.

REPORTING

If you work with FSS, you can expect accurate, consistent reporting throughout the trial lifecycle, right up to the production of the clinical study report. In particular, we understand the importance of regular safety reporting.

CREATION OF CDISC DATASETS

We can create Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets from specifications to CDISC standards, then develop study appropriate Tables, Figures and Listings (TFLs). As an FSP, we can provide all three of these services, or you can select individual ones to meet your unique requirements.

PUBLISHING RESULTS

Changes to clinical practice only occur through the publishing of results. We have worked with principal investigators to publish manuscripts  in top-tier journals, including the New England Journal of Medicine,  as well as contributing to clinical study reports and presenting on conference abstracts.

PROTOCOL DESIGN CONSULTANCY

Our experienced team can review, contribute to and review study protocols, ensuring that the right questions are being asked from the start.

Why Select FSS for biostatistics Services?

We’re independent & not-for-profit

Academic integrity is woven into our fabric, thanks to our company structure and the backgrounds of many of our employees. We can be trusted to be fully independent, giving extra weight to your studies.

We work to global standards

FSS has followed CDISC standards for numerous regulatory submissions around the world. We can ensure your data and analyses are ready for submission to any pharmaceutical regulatory agency or organisation, including the FDA and EMA.

Team. As you would expect, our entire biostatistics team is degree-educated, the majority to Masters level. Continual development of our skills and knowledge is a focus at Frontier Science Scotland. And, thanks to being in business for over two decades, you’ll find us efficient and easy to work with.

I have had the pleasure to collaborate with the Frontier Science Scotland statistical team on several different projects over the years.  They have been attentive, professional, and their work is of excellent quality.  I hope to work with them on many more collaborations and highly recommend their services.

Jamie Hoel | Director – Madison, WI Office | Frontier Science Foundation, USA

Biostatistics Experience

We provide our customers with independent analysis or a collaborative approach, depending on the needs of the clinical trial. FSS works in tandem with project sponsors and other project partners, whether they are pharmaceutical companies, non-profits or SMEs.

Other services

Data Management

Speed up your route to a clean and accurate clinical research database by tapping into our expertise.

Quality

Devote your time to research knowing that all regulatory requirements are met using Frontier Science qualtiy systems.

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