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Expert Clinical Trial Management (Phase I-IV)
Advanced Data Analytics for Clinical Trials (Phase I-IV)
Facilitating Better Clinical Decisions
Statswork enables organizations to make informed decisions at every phase of clinical research. Through technical and data analytics expertise, we help support efficiency and accuracy during trials and regulatory compliance, for improved scientific insights and return on investment.
Improving Trial Design Outcomes from Evidence-Based Analysis
Our pharmaceutical scientists analyse complex scientific trial data to uncover patterns that affect efficacy, safety, and patient response. Our approach will lead to enhancements in study design and support timely decision-making to improve clinical outcomes across therapeutic areas.
Delivering Transparency, Impact and Regulatory Confidence
You can count on Statswork to provide transparent, high quality analytic services, from data management to final reporting to the highest global regulatory standards. Insights generated may lead to improved outcome measures, improved resource usage and successful completion of your clinical trial.
Clinical Data Management and Validation
We monitor the data collection and cleaning process and provide validation services, to assure you that the data are accurate, consistent, reliable, and compliant through all phases of your study, which will support valid insights that will help advance the study.
Statistical Analysis and Interpretation
We utilize and apply advanced biostatistics to evaluate treatment effects, safety profile, and patient-reported outcomes to convert your raw data into evidence for the purposes of the decision-making process.
Regulatory Documentation and Compliance
We will draft statistical reports and summaries to furnish audit-ready documents to analyse and summarize your data for registration on a global platform, while ensuring total compliance with regulatory bodies.
Trial Monitoring and Optimization
We will monitor and analyse your trial in real-time for the duration of the study and will look to uncover every opportunity to optimize your study design, enhance participant retention, and provide overall efficiency and return on investment from the study.
Our Industries
Increase Efficiency in Drug Development
The analysis of clinical trial data can help organizations increase efficiency in research from phase I to phase IV, decreasing time in order to reduce cost and speed up getting safe and effective treatments to market.
Ensure Data Integrity and Regulatory Compliance
As part of our rigorous statistical validation and contributions to globally regulatory compliance, we ensure data integrity, transparency and confidence at each stage of clinical trials.
Translate Insights into Strategic Decisions
By interpreting trial data into actionable insights, we allow you to be informed as a strategic decision maker as trial outcomes are improved, product credibility is enhanced, and ROI is maximized.
1. Protocol Development and Study Design
We develop tailored clinical trial protocols that reflect your research goals while considering methodological integrity, ethical considerations, and compliance with international regulatory requirements from Phases I-IV.
2. Data Management and Data Validation
We have subject matter experts that handle all end-to-end data management including data collection, data cleaning and data validation to ensure that the clinical trial data sets are complete, accurate, and trustworthy data, which enables statistical analysis that is substantive.
3. Statistical Analysis and Interpretation
We utilize advanced biostatistical techniques when analysing safety, efficacy, and treatment outcomes. We provide statistically defensible, clear evidence-based interpretations that you can use in your decision making and to demonstrate submission readiness.
4. Regulatory Reporting and Documentation
We prepare comprehensive clinical reports, statistical summaries, and visual representations that are ready for audit and meet global standards (e.g. FDA, EMA, ICH), with the goal of making your communication with stakeholder and/or regulatory agency as simple and easy as possible.
5. Performance Monitoring and Strategic Insights
We provide real-time trial monitoring, clinical performance tracking, and recommendations that are based on data to improve trial efficiencies, increase patient retention, and assure a measurable return on research investment.
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