You need your data rapidly to make crucial dosing decisions during a study. At Quotient, data are available in the study database within hours of collection, ready for remote sponsor access. We facilitate real-time data review and interpretation with interim PK modeling, interim statistical analysis including sample size readjustment and provision of interim listings, along with specific requests per your study needs.
Study databases are built by our expert programmers using industry-standard electronic data capture tools. We understand on-study changes to early phase study designs and dosing are frequent and so our study strategy for study database design is built around flexibility and rapid implementation. Our data managers closely scrutinize and code data (using MedDRA and WHO Drug dictionaries), ensuring you reach interim and final locks on time.
When you need compliant datasets, enlist experts that understand CDISC’s impact on early phase studies and its importance to your future regulatory submission. As a CDISC Gold Member, we have built CDISC into all standard data management and statistical procedures and delivered thousands of study data tabulation model (SDTM) and analysis data model (ADaM) datasets. Our CDISC experts:
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: