Palleos data managers, biostatisticians and statistical programmers offers full support and comprehensive services during the complete lifecycle of a clinical trial. We assist our clients in the elaboration of study design, including adaptive designs, sample size determination, statistical methodology for the study protocol, preparation of statistical analysis plan and statistical programming.
Our biostatisticians provide a scientific approach to study planning and data analysis of clinical and non-interventional studies. Company experts reduce clinical trial uncertainty through innovative statistical methods, blending “gold standard” approaches with Bayesian inference, decision theory and machine learning. Our flexible, high-quality solutions are tailored to individual needs, ensuring effectiveness in complex scenarios.
The primary function of statistics is to handle uncertainty in a rigorous fashion to arrive at accurate inference and decision making. This is especially important in clinical research, where careless planning can quickly lead to patient harm, false or unreliable research results and wasted expenditures.
Our Data Management team ensures the delivery of high-quality and accurate data within desired timelines, tailored to the sponsors’ specific needs. We bridge data acquisition and evaluation in trials, designing well-structured Case Report Forms and ensuring precise and clean data capture through our EDC systems like Veeva CDMS and Medidata Rave. Our compliance with all regulations of data-feeding outlined by respective Ministries of Health, FDA, EMA, and local regulatory bodies is verified through both internal and external audits of Data Management processes.
We boost our efficiency by using state-of-the-art tech, developed by industry leaders. This ensures that we can customize the tools required for your study to precisely meet your requirements.
During the active clinical phase, the biosta-tistics team of Palleos provided significant support in verifying the methodology for collecting, maintaining, validating, and inter-preting data for endpoint evaluation. The statistical analysis plan was created in accordance with industry standards and common data analysis approaches within the global clinical drug development program.
We are happy with the results Palleos has been demonstrating for the project.
The Palleos team met our goals under very difficult conditions. The achievement is quite impressive, considering the challenging circumstances imposed by the global pandemic.
The results Palleos has been demonstrating as the principal CRO for the project were outstanding.
“Clinical Data Management is critical in clinical research. The goal of data management is to provide statistically sound data with the minimum number of errors and missing values. To achieve that we use various software solutions, which, combined with best practices, help improve data quality.”
