Data Management and Biometrics
Collecting and analyzing high-quality data, fast.
- Overview
- Modeling and Simulation
- Protocol Development
- Clinical Data Sciences
- Biostatistics
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- Medical Writing and Reporting
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
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 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.
TBD Based on Stakeholder Resource
TBD based on stakeholder resource.
Contact
Translating Your Science to Medicine.
Partner with us to get fast, actionable data you can rely on.
Related to “Data Management & Biometrics”
News & Events
Supporting the Next Major Health Epidemic
10.19.18
Member of UK Respiratory Therapeutic Capability Cluster
10.19.18
Biopharmaceutical Industry Recognizes Celerion as a Leading Contract Research Organization
10.19.18
Resources
Difficult to Recruit Population
Case Study
Bioanalytical Challenges of Biosimilars
Articles
Keys to Success in Biosimilar Bioanalytical Assay Development and Sample Analysis
Articles