Solutions

KataCliniKa provides statistical solutions, data management, trial data monitoring and protocol compliance solutions, and medical writing to a high standard of quality and professionalism.

• We help you determine the objectives, designs, endpoints and statistical methods needed to answer the research hypotheses of your clinical studies.
• We help you establish the data structures, collection, validation, analysis and reporting methods needed to demonstrate your research objectives.
• We help you monitor the processes and the quality of your clinical trials.

Things We Have Done

Product development statistics and data science strategy, planning and implementation

• All statistical aspects of clinical development including development planning, study design, endpoint evaluation and sample size analysis
• Statistical and data science input to clinical development documentation
• Analysis plans, statistical analysis programming and statistical reporting
• Data overviews and exploratory analysis for clinical development planning
• Medical writing of protocols, Case Report Forms (CRFs), clinical study reports, clinical summaries and publication manuscripts

Regulatory agency meeting preparation and support

• Statistical elements of briefing packages
• Presentations
• Feedback evaluation
• Answer strategies

Oversight of statistical and data science aspects of CRO-based projects

• Evaluation of CRO proposals, budget analysis and evaluation of statistical and data science services
• Technical project coordination and statistics and data science document review
• Electronic CRF/eDiary and interactive voice response system (IVRS) system documentation and testing
• Project and Sponsor-CRO relationship management

In-licensing and out-licensing support

• Statistics and data science due-diligence support
• Transitioning of projects and databases to partners

Systems, processes and training

• Process and project evaluation, and trouble-shooting
• Development of Standard Operating Procedures (SOPs) and work practices
• Bespoke training in statistical aspects of clinical development

Information Technology

KataCliniKa has developed software for data quality and monitoring solutions using existing technologies and developing original methodologies such as the "Data Entry Clinical Information Monitoring and Reporting System" (DECIMARS) which implements hyper-relational techniques to add quality assurance to manage the process of data cleaning and trial monitoring.