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Life Science Solutions support all phases of pre-clinical & clinical development, meeting the requirements of a validated environment while providing significant gains in productivity & efficiency.
Statistical Graphics: Clinical Graphics
Business Challenge: How to most effectively communicate clinical trial results? Graphs are the most effective way to summarise information & the best way for the human eye to notice patterns or deviations. Better graphs improve decision making in less time.
Improve Understanding and Communication Clinical Graphics enables point-and-click creation of advanced graphics & empowers you to more effectively communicate information across the organisation & externally, whether regulatory or marketing. Why not deliver information in a form that allows for quick & easy understanding?
Speed Time to Graphical Competency Rapid creation of statistical graphics without programming while generating code for production jobs. Your team can create more effective graphs faster and eliminate redundant processes.
Reduce time & effort to develop and format graphs Point-and-click graph specification - no programming required. Point-and-click graph styling - for publications, presentations and submissions
Improve the quality of scientific & business decisions
Enable better & faster interactions with regulatory agencies
Clinical pharmacology and pre-clinical toxicology groups are under tremendous pressure to provide accurate and timely reports in support of critical product milestones. In some situations, this can involve the use of disparate systems and manual processes, increasing the risk of error and requiring redundant validation steps. Clinical Study Reporting eliminates manual processes, providing a point-and-click workflow for standardized reporting on pharmacokinetics, toxicokinetics and pharmacodynamics for a wide collection of studies.
Clinical Study Reporting supports a consistent and automated process from data acquisition through document generation and distribution. There is no cutting-and-pasting or programming required for producing standard reports; and all reports adhere to regulatory requirements including 21 CFR 11 and GxP.
Pre-clinical, Non-clinical, Clinical Studies; Analyses & Reports
Supports all pre-clinical, non-clinical and clinical study types, as well as required regulatory components.
IND Filing (Pre-Clinical Studies)
Post IND (Non-Clinical Studies)
Post IND (Clinical Studies)
Clinical Data Review
The cost of clinical trials continues to increase. Clinicians require rapid & guided access to clinical data for critical decision making to ensure that all safety issues are being identified and communicated. Clinical Data Review enables interactive, web-based viewing of clinical data from early & late phase clinical trials. The framework includes summaries from graphical & statistical analyses of adverse events, labs and treatment, with drill down to patient profiles that summarize all available data at the patient level. Clinical Data Review utilizes advanced S+ statistical graphics and analytics for efficient communication of clinical information in the trial data:
Clinical Data Review provides a framework and tools for development and rapid deployment of advanced statistical & graphical summaries on-line or in portable file formats.
Improve the quality of decisions
Speed the drug development effort
Enable better interactions with regulatory agencies
Clinical Trial Design
For innovative clinical trial design, Trial Designer solution provides intuitive interfaces and easy-to-use workflows for designing, monitoring and simulating flexible clinical trials. The solution will assist you in deploying shorter trials while increasing the probability of their success.
The Trial Designer solution is fully integrated
with the award winning S+ platform, a validated, industry standard biostatistics programming environment. Our solution allows you to extend your proprietary and standard methods for greater ease of design and testing.
Reduce Cost and Time of Clinical Trials
Protect Interests of Patients in Trial
Comprehensive Design and Evaluation Tools
Advanced Visualization Tools
Comply with Regulatory Agencies’ Guidelines
Safety Data Analysis
Safety data have traditionally been summarized as tables and listings that are difficult to review and interpret. In today’s climate of heightened safety concerns, these formats are inadequate for quick and accurate interpretation and comprehension. Safety Miner provides methods for the rigorous analysis of safety data. Analysis results and reports can be readily deployed for interactive review and for submission / reporting.
Safety data pose many challenges to the analyst; there are many endpoints (labs/analytes and adverse events) and comparisons to make, resulting in a testing multiplicity issue. Further, AE count data are sparse, thus complicating the analysis. Safety Miner packages include advanced statistical methods such as Bayesian hierarchical models and inside-out machine learning models that directly address the peculiar safety data issues. These methods provide accurate statistical inference and rapid identification of safety signals.
Improve analysis of safety data and identify safety issues faster
Deploy analytic best practices across functional areas
Align with regulatory and company mandates
Please contact firstname.lastname@example.org or call 02 9233 6888 for more information.