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Data Examination and Understanding
Advanced Statistical Analysis for Clinical Trials (Phase I-IV)
Supporting More Informed Clinical Decisions
Statswork helps organizations make informed decisions at each phase of clinical research. Using technical experience and data analytics, we support efficiency, compliance, and improved scientific insights into comparisons and differences that lead to improved return on investment.
Improving Trial Design Outcomes From Evidence-Based Analysis
Our pharma scientists use disciplined analysis of complex trial data to discover patterns in efficacy, safety, and patient responses to interventions. The evidence-based approach we adopt need better study design decisions in timely manner and improve clinical outcomes in multiple therapeutic areas.
Providing Transparency, Impact, and Regulatory Confidence
Statswork provides transparent, high quality analytic services from data management to completion and final reporting at global regulatory standards (US/EMA). The insight from our processes leads to meeting improved clinical outcome measures, more efficient use of resources, and the successful completion of clinical trials.
Data Management and Quality Assurance
We manage the data collection, cleaning, and verification process in its entirety to make sure that your data is accurate, consistent, reliable and compliant at every step in the process of your study, resulting in valid insights that keeps your study moving forward.
Advanced Statistical Analysis and Interpretation
We convert raw clinical trial data into usable evidence to inform decision making, interpreting treatment effects, safety and patient reported outcomes, using advanced biostatistics.
Regulatory Reporting and Compliance
Our statistical reports and summaries will be audit-ready by making sure your data analysis and documentation are compliant with current industry standards with no exception for submission to regulatory agencies around the globe.
Real-Time Trial Monitoring and Optimization
We can real-time monitor your trial and find opportunities for study design optimization, participant retention improvements, and overall trial efficiency, both for quality study results and increased ROI for clinical trials.
Our Sector
Improve Efficiency
During Phase I-IV and beyond, we’re analysing your statistics in order to interpret the data, which reduces delays, and speeds up time to market for safe and effective treatment.
Ensure Quality and Compliance in the Data
We are providing you with data quality and regulatory compliance, so you can have confidence and transparency about your clinical trial every step of the way.
Translate Knowledge into Available Insights
We will help you translate your clinical trial data into actionable insights to make better decisions to improve outcomes, product credibility, and maximize ROI.
1. Study Design and Protocol Development
We assist you in designing personalized statistical plans tailored to your trial protocol while ensuring compliance with regulatory and methodological protocols.
2. Data Management and Data Validation
Your clinical trial data is completely cleaned and validated for accuracy and suitability for analysis, providing a good basis for statistical interpretations to follow.
3. Data analysis and interpretation
We analyse your study's safety, efficacy and data on treatment outcomes utilizing advanced biostatistical methodology, providing decision-makers and the regulatory agencies clear evidence and objective recommendations.
4. Regulatory Reports and Documentation
We produce a compliant statistical report that meets the requirements for the relevant global regulatory submission and prospectively mitigates your burden of communication with the regulatory agencies.
5. Monitoring Trial Performance and Insights
We monitor trial performance in real-time and provide actionable insights driven by data to improve the efficiency of the trial, enhance adherence to the trial, and improve overall return on investment.
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