Rapid access to clinical data and analysis
Interim access to study data facilitated by electronic data capture in our clinics means we can provide earlier data for faster, better-informed dosing and formulation decisions.
CDISC Gold Member
We follow and implement CDISC standards into our processes, for a better understanding of clinical progress and more effective research outcomes.
Integrated into your program
Our data sciences team members are in-house, and a single project manager responsible for overseeing all services is assigned to each study.
Specialized functions within data sciences
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.
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
Data Management
- Data Management Plan, data cleaning, coding, query issue and review
- Provision of interim safety outputs for decision making
- Database close and lock
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
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
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
Statistical and Clinical Programming
When you need compliant datasets, enlist experts that understand CDISC’s impact on early development 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 use the same software as FDA for dataset validation (Pinnacle21 Enterprise edition) and to aid define-xml package generation, and are able to:
- 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
- Offer full define.xml packages, including define.pdf, trial design datasets, subject-level datasets, traceability documentation and data review guides