Quality clinical study data. Fast.
Quotient Sciences understands that our customers need high quality data rapidly available to support crucial decisions during a study.
Faster processes mean we can provide our customers with earlier interim data and reports for within-study decisions.
We are experts in complex, multi-part, flexible protocols and understand that sponsors need to be able to respond quickly to emerging data, with changes to study designs and dosing.
We are a CDISC Gold Member and CDISC standards are built into all our data on over 400 early-phase studies.
We have over 100 in-house data scientists working within six specialist functions as described below. Each function will be optimized around your study objectives and help maximize your use of study data.
Interim access to study data ‘facilitated by electronic data capture in our clinics means we can provide our customers with earlier data to make dosing and formulation decisions, faster.
Our study strategy for our customers is built around quality, flexibility, and rapid implementation. We recognize that you need rapid access to clinical data to make crucial decisions.
A single Project Manager is assigned to each integrated study for all services including drug product, clinical, and data sciences.
Our Data Sciences team includes six specialist departments with over 100 colleagues
Our statistical and pharmacokinetic experts understand clinical pharmacology studies and their specialized challenges. They are available to work with you to optimize your study objectives, design and sample size, and maximize your use of study data.
Learn more about each of the functions within our Data Sciences team:
1. Data Management and Database Programming
- Single eSource/eCRF database set-up and maintenance
- Study database build using a Phase I dedicated eSource system. A single system is used for both eSource collection in clinic and as an eCRF for data management. This single eSource/eCRF combined with Quotient Sciences processes enhances data quality, reduces data query rates, the need for data transcription and shortens timelines
- External safety data reconciliation using SAS
2. Data Management
- Data Management Plan, data cleaning, coding, query issue and review
- Provision of interim safety outputs for decision making
- Database close and lock
3. Statistics
- Input into clinical protocols and designs, ensuring all output complies with the ICH, CHMP and FDA
- Sample size calculation, randomization and blinding
- Development and input into the Statistical Analysis Plan
- Formal statistical analysis and expert interpretation to assist with decision-making
4. Pharmacokinetics (PK)
- Input into study designs and clinical protocols
- PK parameter estimation (Phoenix WinNonlin) including rapid interim analysis
- Expert analysis and interpretation including interim assessments to support real-time decision-making
- Modeling and simulation using GastroPlus, including development of IVIVCs
5. Medical Writing
- Clinical Protocol and Informed Consent Form writing
- Clinical Study Report according to FDA and ICH E3 guidance for industry, and related submissions using eCTD specification
6. Statistical and Clinical Programming
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 standards into all our data management and statistical procedures for over 400 early phase studies. We also use the same software as FDA for dataset validation (Pinnacle21 Enterprise edition) and to aid define-xml package generation.
Our experts:
- Develop dataset specifications and an aCRF with reference to SDTM and ADaM implementation guides
- Program study listings, tables and figures for inclusion in the Clinical Study Report
- 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 pharmacodynamic data
We also offer full define.xml package including define.pdf, trial design datasets, subject-level datasets, traceability documentation and data reviewer’s guides