Accurate, robust data is at the heart of all our work, and we have an expert team dedicated to ensuring quality in data management and statistical analysis for all of our project needs.
In addition to providing overarching support for data-related activities across the entire organization, our data scientists contribute to clinical trial implementation through:
- Statistical planning, including the development and review of statistical analysis plans (SAPs) and the definition of clinical studies (e.g. sample size, enrollment procedures)
- Data analysis and reporting, in line with standards of reproducible research
- Data management, including setting up of case report forms (CRFs), database creation, site trainings that support compliant data collection, continuous data monitoring, database lock, and data cleaning.
Data services also underpin the FIND Specimen Bank, which uses the open-source platform OpenSpecimen. In particular, we are developing innovative plug-in tools that facilitate the integration of OpenSpecimen with clinical databases, which can be used by the entire scientific community. Statistical support is provided for studies that have been conducted using specimens from the FIND Specimen Bank, through our FINDings service. We also provide inventory management and develop bespoke specimen labeling processes.
We regularly develop tools that can support data monitoring and data visualization, as well as sample size calculators. Specific analyses are also conducted to support the development of key publications.
Our data management software is compliant with 21 CFR part 11, HIPAA, GDPR, ICH-GCP, has an auditable quality system, and is ISO 27001 certified.