You need data rapidly to make crucial decisions during a study. Faster data means we can provide our customers with earlier interim data and interim PK reports for on-study dosing and formulation decisions.
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.
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 SDTM and ADaM datasets according to specifications, including verification, quality control and validation
Provide metadata files and blankcrf.pdf
Include all clinical, pharmacokinetic, pharmacodynamic and scintigraphic data
We also offer full define.xml package including define.pdf, trial design datasets, subject-level datasets, traceability documentation and data reviewer’s guides
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