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Pharmacometrics
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Covance's global pharmacometrics organization is your complete data management, data analysis and reporting solution for clinical pharmacology.
From our clinical research units in Leeds, UK, and Madison, Wisconsin, we offer a full range of support for the successful completion and efficient analysis and reporting of Phase I and II studies.
The organization is designed to meet your needs. You select the services you require — from a single item, such as Case Report Form (CRF) design, to the complete management and coordination of clinical pharmacology programs for regulatory submission.
We offer the following pharmacometrics services:
Data Management
- Case Report Form (CRF) design and printing
- Database design and data entry
- Query management
- Medical coding (MedDRA, WHO DRUG as standard)
- Database consolidation
- Electronic Data Transfer (EDT)
- Status reports.
Statistics and Programming
- Sample size calculations
- Treatment randomization and code break envelopes
- Statistical analysis of clinical PK/PD endpoints
- Meta/integrated analysis
- Summary tables, figures and listings
- Integrated Safety Summary (ISS)/ Common Technical Document (CTD) tables
- Statistical reports
- Ad hoc data summaries.
Pharmacokinetics/Pharmacodynamics
- Rapid interim PK analysis
- Noncompartmental PK and PD analysis
- Toxicokinetic analysis
- Bioanalytical data review
- PK reports/contributions
- Population PK
- PK/PD modeling and simulation.
Medical Writing
- Fully integrated clinical and PK/PD reports for electronic submission
- Marketing/regulatory documents — writing and editing
- Scientific posters and papers
- Protocol preparation
- SOP writing
- Investigator drug brochure preparation and update.
Program Management
- Management and coordination for study programs in which clinical aspects are conducted at centers worldwide
- Data management, biostatistics, programming and reporting of every study provided in one agreed-upon format
- Creation and management of global clinical pharmacology databases
- Overall program timelines driven by regulatory submission
- Case study.
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