The Celerion Data Management and Biometrics team are market leaders in Phase I adaptive study designs, clinical data management, and PK/statistics reporting. We have the scientific and clinical pharmacology expertise to optimize your study design and deliver safety, PK/PD, and cardiodynamic analyses within your timelines.
Clinical Pharmacology and Data Science Expertise to Support Data Analysis
Celerion’s Data Management and Biometrics (DMB) services deliver the highest quality of data analyses and study reports, while minimizing study timelines from start-up to database lock. Our highly skilled team of more than 150 scientists have decades of experience, providing a multidisciplinary approach to protocol development, data management and analysis as well as study report writing.
Study design consultation and writing services include determination of FIH dose, protocol development and writing as well as review of client synopsis/protocols.
Harnessing advanced tools and global expertise, we deliver end-to-end solutions—including intelligent e-Source, EDC, CRF design and build, data import/integration, flexible and accelerated database lock options, and rapid delivery of CDISC compliant submission-ready SDTM data packages.
Integrated statistical support for data management and PK science activities includes sample size recommendations, randomization, and statistical analysis plan (SAP) writing as well as SAS programming of ADaM, tables, figures, and listings (TFLs) outputs.
Experienced clinical pharmacologists utilize industry-leading software for PK, PD, and exposure response analyses, in addition to providing study design and analysis plan input, as well as PK/PD written interpretations.
Medical writers review and interpret safety, cardiodynamic, and PD data, collaborating with other subject matter experts to provide high-quality, scientifically sound, ICH-compliant CSRs.
Celerion actively contributes to the development and evolution of CDISC standards, helping to drive future data initiatives across the industry. Leveraging this involvement, Celerion delivers top-quality, SDTM- and ADaM-compliant data packages that meet regulatory requirements for submissions across a wide range of therapeutic areas.
We do it all: study design consulting and protocol writing; PK/PD, safety, cardiodynamic analyses; as well as reporting and submission package preparations. We aim at addressing your research question while getting the most out of your study. Leverage our experienced team of protocol writers to develop adaptive and creative first-in-human (FIH) and product labeling study designs (e.g. ADME, drug-drug interaction, food effect, bioavailability/bioequivalence, and thorough QT studies). Our clinical pharmacology and pharmacometrics experts are intricately involved in study design, case report form (CRF) design, data review, statistical analysis plans, and analyses. They prepare scientifically robust, submission-ready plans, documents, and reports. Our end-to-end service offerings, combined with immediate access to data, enable customers to execute faster go/no-go decisions.
Data flow within our systems (clinical, bioanalysis, and DMB) is automated and minimizes errors for streamlined efficiency. Working with our extremely skilled team of scientists and medical writers ensures the timely delivery of high-quality study reports while conforming to regulatory requirements. Our scientific team of pharmacologists, protocol scientists, statisticians, and medical writers seamlessly collaborate to optimize your clinical trial and readily provide study reports to a high scientific standard. Our DMB team members have experience across a diverse range of therapeutic areas (including cardiovascular, respiratory, metabolic, inflammation, immunology, and neurology) as well as drug moieties (small molecules, biologics, oligonucleotides, and vaccines).
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