CLINICAL TRIAL MANAGEMENT
Biostatistics and Programming
The interpretation of clinical trial data is crucial for making informed decisions. Our biostatisticians provides expert statistical analysis and interpretation, enabling clients to understand the implications of their data. This analysis supports informed decision-making and is essential for regulatory submissions.
Our biostatisticians work closely with other team members to ensure that statistical analyses are integrated seamlessly into the overall trial process. Their insights help to highlight key findings and ensure that the results are presented clearly and accurately.
Biostatistics Services:
Our biostatistics services are designed to ensure rigorous and reliable analysis of clinical trial data, supporting the successful development and regulatory approval of medical devices and imaging technologies. Biostatistics services include:
Study Design and Protocol Development
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Collaborating with clinical teams to design scientifically sound and statistically robust clinical trials.
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Developing statistical sections of study protocols, including sample size calculations, randomization plans, and endpoint definitions.
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Ensuring alignment with regulatory guidelines and best practices for medical device and imaging studies.
Statistical Analysis Plan (SAP)
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Creating detailed Statistical Analysis Plans (SAPs) tailored to the specific needs of medical device and imaging trials.
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Defining primary and secondary endpoints, statistical methodologies, and data handling rules.
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Ensuring thorough documentation for regulatory submission and review.
Randomization and Blinding
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Designing and implementing randomization schemes to minimize bias and ensure the integrity of the trial.
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Managing blinding procedures to maintain study credibility.
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Generating randomization lists and providing secure randomization services.
Interim Analysis and Data Monitoring
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Conducting interim analyses to assess study progress and safety.
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Supporting Data Monitoring Committees (DMCs) with statistical expertise and interim reports.
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Implementing adaptive trial designs and making data-driven decisions to optimize trial outcomes.
Development of Statistical Models
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Creating and validating statistical models tailored to medical device and imaging data.
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Utilizing advanced techniques such as survival analysis, regression models, and mixed-effects models.
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Ensuring accurate and reliable model outputs to support decision-making.
Data Analysis and Interpretation
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Performing comprehensive statistical analyses using advanced methodologies.
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Analyzing efficacy and safety data, including subgroup analyses and sensitivity analyses.
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Interpreting results in the context of clinical relevance and regulatory requirements.
Preparation of Statistical Reports
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Generating tables, listings, and figures (TLFs) to summarize study findings.
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Preparing comprehensive statistical reports for regulatory submissions, manuscripts, and presentations.
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Ensuring clarity and transparency in the presentation of statistical results.
Regulatory Submissions and Support
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Providing statistical input for regulatory submissions, including IDE, 510(k), PMA, and CE Mark applications.
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Preparing responses to regulatory agency queries and requests for additional analyses.
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Ensuring compliance with regulatory standards and guidelines.
Post-Market Data Analysis
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Analyzing post-market surveillance data to monitor device performance and safety.
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Conducting real-world evidence studies and comparative effectiveness research.
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Supporting post-market regulatory submissions with robust statistical analyses.
Training and Consultation
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Offering training for clinical and regulatory teams on statistical concepts and methodologies.
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Providing ongoing consultation and support throughout the trial lifecycle.
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Ensuring the application of best practices and up-to-date statistical techniques.