BL Solutions Information

BL Solutions is a privately held company, with a futuristic objective of creating, maintaining and enhancing healthy relationships. Our Clinical Data Managers (CDMs) understand their role as part of the global study team and being accountable for the final quality of the clinical study data. BL Solutions uses well-established and efficient processes for both paper-based and Electronic Data Capture (EDC) trials. Data Management Services include: Detailed CRF Design and Review 21 CFR Part 11-Compliant Systems Double-Data Entry EDC with Flexible Reporting Comprehensive Data Validation Remote Data Access Clinical Biostatistics: BL Solutions genesis was in statistical consultation. Our senior Biostatisticians have served as independent reviewers of major studies in many therapeutic areas. They bring expertise and insights in designing trials and developing complex statistical analysis plans. Our statistical programmers are current with the latest programming techniques and features of the SAS system, among other statistical software packages. BL Solutions extensive experience allows us to develop a statistically rigorous and customized plan for each project.BL Solutions execution of the data analysis plan produces report ready summary tables, data listings and figures for interpretation and inclusion in the study report or submission. A thorough verification and senior review process substantiates the accuracy and completeness of all statistical analyses. Biostatistical Services include: Protocol Development and Review Study Design and Sample Size Estimation Randomization Procedures Statistical Analysis SAS Programming Client Customized SAS Datasets Data Listings/Tables Statistical Analysis Graphical Data Presentations FDA Representation Responsive, Interactive Statistical Consulting on Demand