Overview
Protocol Design
Engage with our team of Biostatisticians from the earliest stages of study development.
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Sample Size
We have expertise and software necessary to perform sample size calculations for any design.
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SAP Development
We will prepare all statistical methods necessary to meet the needs of the study.
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IDMC Support
We have extensive experience and expertise providing quality independent statistical support and customized reports and graphs.
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CDISC Datasets
Our knowledgeable and experienced team can upgrade your database to be SDTM and ADaM compliant.
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Statistical Analysis
We have the ability and experience to perform all necessary statistical analyses over the course of the study.
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Study Reporting
Work with us and ensure that all study reporting is accurate, thorough, and timely.
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Regulatory Support
Our team has experience compiling quality submissions for regulatory agencies.
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Publishing Results
Collaborate with us to share your study results with the Scientific community.
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Customized Statistical Reporting
Frontier has developed a graphically based reporting system which can be utilized to efficiently and effectively display study results over the course of a study. This unique reporting style sets us apart as it enables reviewers to quickly zero in on the information they need.
Frontier Science’s experienced team of biostatisticians can be relied upon to collaborate on study design, to ensure that your research achieves its objectives efficiently and effectively.
We have experience with a wide range of methodologies, including complex, innovative, and adaptive designs. We have also worked on studies of all phases, I-IV, and across many indications, including but limited to HIV, tuberculosis, cardiovascular disease, and cancer.
Our team will work with you to tailor the design your study to ensure it meets the specific needs and addresses all study questions.
Partner with us to ensure that your clinical studies are designed with the highest probability of success.
As part of protocol design, Frontier Science’s statistical team has the expertise and tools to calculate the sample size for a study of any phase and design.
For studies with formal comparisons during interim monitoring, we can help you think about stopping rules and ensure that sample sizes allow for multiple looks at the data.
Collaborate with us to ensure that your clinical trial is sufficiently powered to answer the objectives of the study.
Selecting the correct statistical methodology is crucial for any clinical study. Our team of expert Biostatisticians are will equipped to create a statistically sound Statistical Analysis Plan for your study.
We will specify in detail the necessary information for each statistical analysis, including example layouts of the results.
We have years of experience in this area across many types of studies, including areas such as adaptive designs and mixed methods. Let us put our skill to work for you in this extremely important area of the study.
Frontier Science’s Independent Statistical Center (ISC) has decades of experience in statistical support of Independent Data Monitoring Committees (IDMCs).
We have worked on 100+ studies over the years across many types of studies and disease areas. Our internally developed, graphically based reporting system sets us apart as it enables the IDMC to quickly zero in on the information they need. Partner with us and your study’s IDMC will receive top level independent statistical support.
Frontier Science’s talented team of biostatisticians and programmers have the ability to convert your clinical database into CDISC compliant datasets.
We can create Study Data Tabulation Model (SDTM) datasets and develop specifications and programs to create Analysis Data Model (ADaM) datasets.
Work with us to ensure a seamless CDISC migration of your database.
Our statistical team has the expertise and knowledge to successfully and efficiently execute the statistical analysis of your study. We have decades of experience working across many types of studies and therapeutic areas, implementing a very wide array of statistical methods within our work.
We can produce all statistical analyses required for formal interim analysis during the study, as well as final analysis upon the conclusion of the study. We can analyze data according to statistical analysis plans prepared by our statisticians or yours.
Partner with Frontier and our team will complete each and every statistical analysis accurately and efficiently.
Regular reporting of study data, in particular safety data, is an important task during the course of a study.
Frontier Science’s team has the expertise and experience necessary to produce accurate, timely, and consistent reporting throughout the duration of the study.
We provide reports for study teams as well as independent data monitoring committees.
Collaborate with us to ensure that all study reporting is successfully completed to meet all expectations.
Frontier Science’s team of Biostatisticians and programmers have years of experience working within the regulatory environment.
We understand the many tasks that need to be completed for regulatory agencies over the course of a study.
Work with Frontier and we will address these regulatory requirements.
Upon the completion of your study, the next step is to inform the scientific community of your results.
Our team of biostatisticians can be relied upon to provide expert statistical input towards the
publications of your study.
We have worked with principal investigators to produce manuscripts for top tier journals and provide statistical contributions to clinical study reports.
Collaborate with our team on this important task.
Accrual
Accrual data of subjects are displayed in a combination of charts, providing an overview and the current status of ongoing clinical trials.
The charts may further break down into subpopulations such as states, countries, or other stratifications incorporated in a trial.
KM Curve
Dichotomous response variables such as death for subjects with variable lengths of follow-up are often displayed as Kaplan-Meier (product-limit) ’survival’ curves across time.
The total number of events appear on the plot, as do the numbers of subjects at risk (event-free and uncensored) at various points of follow-up.
Forest Plot
A Forest Plot shows the hazard ratios between treatment groups along with 95% confidence intervals.
The analysis is applied to the overall population as well as subpopulations of interest, such as genders, geographical regions, or baseline characteristics.
Boxplots
Boxplots display the distribution of continuous data by means of percentiles, including but not limited to physical measures, vital signs, ECG, and laboratory parameters. Boxplots may also be used to display change from baseline or percent change from baseline for each of the continuous variables.
Unless otherwise noted, the top and bottom edges of the box represent the 25th and 75th percentiles of the data. The 5th and 95th percentiles are represented by the “whiskers” extending from the top and bottom of the box. The plotting symbol inside the box represents the median of the data.
Bar Charts
Simple bar charts are used to display single categorical variables with mutually exclusive categories.
Bar charts of related dichotomous variables may sometimes be grouped together to form a multiple bar chart.
Stacked Bar Charts
Stacked bar charts are used to show subcategories of AEs, SAEs, or other variables of interest. AEs may be categorized by severity (severe, moderate, mild), relationship to the treatment (related, unrelated), status (resolved, not resolved), or frequency per subject.
The percent of subjects within the subcategories are indicated by shading in a stacked bar chart.
Expertise
Our broad experience with all aspects of clinical trials enables us to understand and anticipate the specific needs of each study. Beyond producing reports, our Statistical team engages scientifically with the studies at hand and provides intellectual input.
Teamwork
Frontier assigns a team of biostatisticians and programmers to fit the needs of each study. In addition, our thorough processes include support for validation of all outputs, as well as support from our Quality Assurance department to ensure all compliance of all our work.
Reporting
Our reporting style is flexible to best address the needs of all collaborators. In particular, our highly graphical approach to Independent data Monitoring Committee (IDMC) reports hone in on what the IDMCs are looking for. This enables the the IDMC to review a lot of material in a relatively efficient way.
Security
Frontier takes great care to protect the integrity and confidentiality of trial data, including working in a computing environment that meets key regulatory security standards such as HIPAA Security Rule and FISMA.
Continuity
The statistical team work closely with all collaborators throughout the entire duration of the trial, from inception through closeout. Many statisticians have worked at our organization for a long time, and this unique level of continuity is beneficial to all trials, especially long term ones.
Responsiveness
Our statistical team ensures that a snapshot of the study data is readily accessible, as needed, to quickly and efficiently address all requests as the study progresses.
Our Statistical Team
Our statistical team has decades of experience in providing guidance on the optimal statistical and study design needed to address the scientific hypothesis, and works closely with the data management team to assist in case report form development, randomization guidelines, and monitoring plans.