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Navigating the complexities of clinical trial design requires expert guidance. CP Analytics offers comprehensive statistical consulting services tailored to the unique needs of your clinical research project. Our team of experienced statisticians and programmers is proficient in dealing with the complexities of clinical data, ensuring that the most appropriate statistical methodologies are utilized for your research. We will work closely with you at every stage of the clinical trial process, providing insights that will help you in making informed decisions, interpreting results accurately, and maximizing the value of your data. By leveraging our statistical consulting expertise, your projects are positioned for success, with clear findings that can drive forward clinical development and contribute to scientific understanding.
Our statistical consulting services are designed to address the multifaceted challenges faced by researchers and developers in clinical research. We can assist with sample size calculations, consulting on study design, pharmacokinetics analyses, clinical analysis for all study phases, and support regulatory agencies communication on statistical matters. CP Analytics can also assist with the preparation and review of statistical documentation for your clinical trial (e.g. Statistical Analysis Plan, Randomization and Blinding Plan, and Statistical Validation Plan). CP Analytics offer comprehensive statistical consulting services that cover the entire spectrum of study design, implementation, and analysis. Our mission is to empower companies to make informed, data-driven decisions that propel the progress of science and medicine.
Utilizing both standard and advanced statistical methods, our team is adept at navigating the complexities of clinical data to extract meaningful insights. Our expertise encompasses a range of statistical techniques, from conventional analyses to more sophisticated models that account for the dynamic nature of clinical research. This methodological rigor enables us to deliver nuanced understanding and actionable intelligence from clinical data.
A pivotal area of our expertise lies in the creation and review of CDISC datasets, including ADaM and SDTM datasets. Our proficiency in adhering to these standards ensures that the datasets we prepare are not only compliant but optimized for regulatory submission. This meticulous attention to detail facilitates a smoother review process by regulatory bodies, enhancing the likelihood of approval.
Preparation and review of regulatory submissions are among our core services, offering clients peace of mind that their submissions are backed by rigorous statistical analysis and compliant dataset formats. We understand the regulatory landscape’s nuances, tailoring our support to meet the specific needs of each submission.
In the era of modern clinical trials, risk-based monitoring (RBM) is a proactive approach to trial oversight. Our statistical expertise enables us to identify potential risks early in the study, allowing for targeted monitoring strategies that focus on the most critical data and processes. By implementing RBM, we help you reduce trial costs, enhance data quality, and ensure regulatory compliance, all while maintaining patient safety and trial integrity.
Regulatory submissions are a critical step in the drug development process. In today’s clinical research environment, ensuring patient safety and data integrity while optimizing resource allocation is paramount. Our team provides statistical analysis and reporting support to DMCs, and other safety monitoring boards offering detailed data analyses and reports. CP Analytics can assist with the Blinded or Unblinded teams of the DMC process.
