Life Science

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

• Comprehensive palette of graphs provide clarity for complex data sets
• Clinically-relevant graph templates adapt to changing data
• Specialised safety/efficacy graph templates enable faster detection of safety and efficacy signals
• Comparative graphical analysis on all safety and efficacy data

Enable better & faster interactions with regulatory agencies

• Integrate S+ graphics into validated reporting environments through simple SAS® macros
• Themes and auto-populating metadata fields improve consistency of regulatory submissions

Select standard and custom graph types and specify graph elements, creating statistical graphics for use in presentations and publications.

Apply new styles to all elements in a graph by selecting a new Theme.

Clinical Reporting

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.

• Eliminate manual QC processes
• Reduce reporting time up to 75%
• Enforce analysis and reporting best practices

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.

Select study details, report format and output preferences. Report graphs and tables are produced in strict adherence to detailed formatting requirements.

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)

• Short-term Toxicity and TK studies (rodents, higher mammals)
• Carcinogenicity studies (transgenic mice)
• CV, CNS studies

Post IND (Non-Clinical Studies)

• Longer-term TK studies (higher mammals)
• Reproductive Toxicology (genotox, placental)
• Carcinogenicity studies 
• Biomarker / PD response studies

Post IND (Clinical Studies)

• PK studies – Single ascending dose, Multiple ascending dose, Bioequivalence
• Biomarker / PD response studies
• Exposure / response 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:

• Identify safety issues quickly
• Guided data review for clinicians, ensuring best practices
• More and better information exchanged in meetings - internally and with regulatory agencies

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.

Select adverse event and/or lab summaries then drill to patient profile. Clinical graphics / statistics menu on left and on-top banner may be configured to customer requirements.

Improve the quality of decisions

• Select the best dose in early-phase trials
• Identify patients with lab and/or AE issues early in all trials
• Identify potential data errors and enable data cleanup
• Discern safety and efficacy signals in all early and late phase trials

Speed the drug development effort

• Comprehensive data display at the fingertips of your entire team
• Real-time review of all trial data
• Interim analysis of safety and efficacy
• Appropriate attrition and advancement of compounds

Enable better interactions with regulatory agencies

• Online and portable trial summary enables in-time support of FDA interaction team for FDA meetings

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.

• Point-and-click and S-PLUS® programming interfaces
• Packaged, sequential clinical trial designs
• Custom (e.g. adaptive) designs and outputs
• Validated installation and operation

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.

Compute, evaluate and compare clinical trial designs

Reduce Cost and Time of Clinical Trials

• Simulate multiple trials to examine effect on power & type 1 error
• Promote rapid discovery of new beneficial treatments
• Discriminate between relevant scientific hypotheses
• Integrate with your  electronic data capture (EDC) methods

Protect Interests of Patients in Trial

• Stop when credible decision can be made
• Stop if unsafe or unethical

Comprehensive Design and Evaluation Tools

• All commonly used group sequential designs, boundary shapes and scales included
• Comprehensive evaluation tools: Power, conditional power, sample size distribution, inference at the boundaries, and Bayesian analyses
• Flexible Monitoring Methods: Implementation of stopping rules based on error spending functions or constrained boundaries
• Exact p-values, confidence intervals; bias adjusted estimates of treatment effect

Advanced Visualization Tools

• Comprehensive set of specialized plots for study design: Power curves, ASN (average sample size) curves, and stopping probabilities
• Trellis graphics for powerful and effective comparison of designs

Comply with Regulatory Agencies’ Guidelines

• FDA ICH-E9

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.

• Quantify treatment effects on safety endpoints
• Identify safety signals quickly and accurately
• Select the best dose in early-phase trials
• Identify patients with lab and/or AE issues early in all trials

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.

pRisk plot from hierarchical Bayes analysis of adverse event rates

Improve analysis of safety data and identify safety issues faster

• Rigorous statistical analysis of safety data
• Advanced statistical methods that overcome limitations of traditional methods

Deploy analytic best practices across functional areas

• Reporting of analysis results to safety, epidemiology and clinical study teams
• Deployment of best practices safety analysis throughout organization
• More efficient use of biostatistics resources

Align with regulatory and company mandates

• Analyses supporting periodic and aggregate review of safety data

Please contact enquiries@solutionmetrics.com.au or call 02 9233 6888 for more information.