Data Management and Database Programming
- 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
- 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
- Protocol writing
- Clinical study report according to FDA guidance for industry and related submissions using eCTD specification
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.
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
Modeling and Simulation
Enhance your clinical development program with our modeling and simulation services. Quotient Sciences’ experts’ help you pinpoint the question you need to answer and identify the data you need to collect.
We provide in silico modeling and simulation for all your formulation design and selection programs. Our experts use GastroPlus™ to model physicochemical, biopharmaceutics and pharmacokinetic data, expediting valuable insight into the in vivo performance of your molecules and formulations.
Your first-in-human program, using our integrated Translational Pharmaceutics approach, benefits from the simulation of exposure profiles, which help to select doses and define robust formulation strategies. Similarly, in drug optimization programs, we apply GastroPlus to select formulation technologies and compositions, and to optimize your drug product performance within the protocol. We also evaluate potential in vitro-in vivo correlations (IVIVCs), offering significant downstream benefits to your development team including drug product specification setting, managing pre/post approval CMC changes and justifying biowaivers based on dissolution data.
Clinical Pharmacology Services
Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment.
See real results
Discover how pharmaceutical and biotechnology organisations have achieved success using our clinical pharmacology services.