Need rapid results to clinical data to accelerate drug development?
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Accelerating data collection for rapid implementation
You need data rapidly to make crucial decisions during a study. We understand that 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 Miami (US) and Nottingham (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.
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.
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
Data Sciences
Go further with Quotient Sciences
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Clinical Pharmacology ServicesClinical PharmacologyWhatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and recruitment.
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Study ResultsCase StudiesDiscover how pharmaceutical and biotechnology organizations have achieved success using our clinical pharmacology services.