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Protocol input, sample size calculation and randomization, Statistical Analysis Plan and formal statistical analysis/interpretation, Program/QC study listings, tables and figures using SAS, Program/QC CDISC datasets (SDTM and ADaM) using SAS, Define.xml.
Rapid interim PK turnaround times for formulation decisions or SAD/MAD safety evaluation, Modeling and simulation using GastroPlus, including development of IVIVCs
Leveraging our industry-leading ClinPlus® eClinical software platform to manage the trial, ensure data accuracy and implement smart, proprietary algorithms to identify and mitigate risk
MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification
Our statistical, pharmacokinetic and scintigraphic experts understand clinical pharmacology studies and their specialized challenges. Optimize your study objectives, design and subject numbers, and maximize your use of study data:
Chiltern’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver the high-quality statistical output required for every aspect of drug development including the statistical
Our statisticians develop statistical analysis plans, which reflect study goals and closely follow the ICH guidelines for the design of case report forms (CRFs), database structure, data plausibility checks, and quality control procedures as well as choice of study objectives, sample size calculation,
Celerion’s statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often consulted to perform special calculations and summarizations of information for non-study-related issues for problem solving and process improvement.
PPD’s global clinical biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance.