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CP Analytics provides specialized biostatistics and statistical programming support for vaccine clinical development. Our statistical approach is tailored to the vaccine platform, phase of development, study design, immune-response endpoints, safety objectives, and regulatory requirements of each program.
We support the development of statistically rigorous vaccine protocols and analysis strategies, including definition of primary, secondary, and exploratory endpoints; estimands and analysis populations; sample size and power considerations; randomization and stratification; multiplicity considerations; handling of intercurrent events and missing data; sensitivity analyses; and development of Statistical Analysis Plans (SAPs).
CP Analytics provides statistical analysis of humoral and other protocol-defined immune-response endpoints. Analyses may include:
Analyses are performed using appropriate transformations and statistical methods for highly skewed antibody data, including log transformed titers and back-transformed estimates with confidence intervals.
CP Analytics supports analyses of:
Reactogenicity analyses can evaluate incidence, severity, duration, time of onset, and treatment-group comparisons.
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.
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.
