Biometrics

Biometrics

Biometrics Expertise for Clinical Trials and Regulatory Submissions

Not all therapies make it to the patients that need them, not because they did not work, but because the design, data collection and/or analysis were not done right. Correctly designing, collecting, analyzing, standardizing, and reporting your clinical trial data to local and global regulatory agencies is critical to your success. To give you an advantage, Bones Medical has assembled an extraordinary team of scientific-minded biostatisticians, programmers, data managers and data standards experts, the power of industry-leading technology platforms and expertise in adaptive designs, to help you understand your data to make critical clinical development decisions.

BIOSTATISTICS

One of the largest teams of statisticians and SAS programmers in Europe within a company is at your service, supporting the planning of your project, during the conduct or reporting phases with solutions that fit your needs:

The Bones Medical Biostatistics team has a long track record of successfully completed projects in a wide range of indications, from Phase I to IV, non-interventional projects, patient registries, epidemiological studies and outcomes research in projects for pharmaceuticals and medical devices, and for national and international projects.

Biostatistics services may include:

• Biostatistical analysis including all tables, figures and analyses according to the SAP.
• Randomization procedures
• Clinical trial design planning and sample size calculations
• Support with data interpretation and development of the study report and/or interim reports
• Development of the Statistical Analysis Plan (SAP) according to the study protocol
• Statistical programming for the final analysis, as well as reports for interim analyses, risk-based monitoring, data monitoring committees, and regulatory submissions.

The biostatistics team plays a vital role in any clinical study in planning the clinical trial design, sample size, randomization procedures, and statistical analysis. Thus, the biostatistician’s expertise is pivotal in ensuring a robust data analysis and making sure that the clinical study has sufficient power to answer the primary objective.