Data Management and Biometrics

Unique, Scientific Data Management and Biometrics Team

Data Management and Biometrics scientists at Celerion bridge the gap between medical practice and laboratory science by assessing the safety of drug products to maximize drug effects and minimize side effects. Deeply knowledgeable, with 40+ years of experience, 5,000 protocols developed, and over 200 clinical study reports produced each year, we have the scientific expertise to help you make informed go/no-go decisions earlier.

Generating High-Quality, Reliable Data for Informed Decision Making

Celerion is a member of the Clinical Data Interchange Standards Consortium (CDISC) and supports the submission of compliant SDTM and ADaM packages for regulatory submissions across multiple therapeutic areas. What’s more, as a member Celerion contributes to the development of these standards and drives initiatives for future data standards.

Our Biometrics team’s insightful counsel assists you in developing efficient, scientifically sound studies, analyzing the data, and using that knowledge to optimize future studies in your drug's development. We do it all: study design consulting, modeling, data collection, analysis, and reporting—and our data flow process is streamlined and transparent so that you can view the results online in real time.

Working Collaboratively Across Disciplines

Our scientific team of pharmacologists, protocol and design scientists, statisticians, PK/PD specialists, and medical writers seamlessly collaborate to optimize your clinical trial and provide accurate results swiftly. These are some of the ways we optimize for efficiency and maintain our high standards for data:

• We use adaptive and fusion study designs to integrate objectives and reduce time between first-in-human and clinical proof-of-concept trials.
• Our statisticians and medical writers work directly with our study design specialists in order to optimize design, improve accuracy of data, and shorten projected timelines.
• With diverse backgrounds in pharmacology, physiology, therapeutics, and acute and chronic diseases, our scientists look beyond basic safety analysis of data to consider all factors that may affect your study’s results.
• Our data undergoes complete cleaning and preparation for submission, including logic checks, query management and formatting to meet CDISC standards.
• To ensure on-time delivery of data, we’ve streamlined our data flow by developing numerous macros and standardized programs, analysis codes, and output formats.