Data Sciences

How do I access expert data services for my clinical pharmacology studies? Quotient is your answer.

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Data Management and Database Programming

Study set-up

Study database set-up and maintenance
Data Management Plan, data cleaning, coding, query issue and database lock

Statistics and Statistical Programming

Protocol input, sample size calculation and randomization
Statistical Analysis Plan and formal statistical analysis/interpretation
Program/QC study listings, tables and figures using SAS
Program/QC CDISC datasets (SDTM and ADaM) using SAS
Define.xml and related documentation

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Pharmacokinetics

Rapid interim PK turnaround times for formulation decisions or SAD/MAD safety evaluation
PK analysis using Phoenix WinNonlin
Modeling and simulation using GastroPlus, including development of IVIVCs

Medical writing

Protocol writing
Clinical study report according to FDA guidance for industry and related submissions using eCTD specification

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Rapid data delivery

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.

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Standardizing study data with CDISC

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:

Develop dataset specifications and an aCRF with reference to SDTM and ADaM implementation guides
Program SDTM and ADaM datasets according to specifications, including verification, quality control and validation
Provide metadata files and blankcrf.pdf
Include all clinical, pharmacokinetic and scintigraphic data
We also offer full define.xml package including define.pdf, trial design datasets, subject-level datasets, traceability documentation and a data reviewer’s guide

Statistics, Pharmacokinetics and Scintigraphy

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:

Access input into clinical protocols and designs and ensure all output complies with the ICH, CHMP and FDA
Provide data analysis and interpretation, such as interim assessments to assist you with real-time decision making
Leverage expert review and interpretation of scintigraphic data, including qualitative and quantitative analysis of drug product performance and pharmacodynamic effects during your study