You need data rapidly to make crucial decisions during a study. Faster data means we can provide our customers with earlier interim data and interim PK reports for on-study dosing and formulation decisions.
We understand on-study changes to early phase study designs and dosing are frequent and so our study strategy for study database design and reporting is built around flexibility and rapid implementation. We use eSource data collection procedures in our clinical units and a joint eSource/eCRF database. Data are available in the study database within hours of collection, ready for remote sponsor access.
Our data science experts support studies conducted at our US and UK clinics. With global SOPs, templates and standards, we also adapt them for use with sponsor templates/standards. Our services are fully integrated and we assign a single Project Manager for all drug product, clinical and data sciences activities. Data Science at Quotient comprises six specialist departments and over 80 staff:
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 for over 250 early phase studies. Our 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: