We understand that to support the delivery of superior clinical outcomes, your clinical studies require modern and intelligent data management. Our biometrics specialists are central to our full-service solutions, providing our customers with transformative methods that will change the way you think about a quality CRO. Our team is always on hand to provide guidance and planning for full optimization of your study design, in order to meet your objectives and ensure delivery of data you can rely on.
Full life-cycle support
Our comprehensive and flexible services cover the full biometrics life cycle, from the initial study design, including sample size calculations, to the final statistical analysis and clinical study reporting. As master users of Viedoc™, the cutting-edge electronic data capture (EDC) system, we will offer highly sophisticated functions optimized for your project regardless of the clinical trial phase. We take complete responsibility for managing your eCRF design and set-up, as well as data validation, while also providing continuous support for your risk-based or centralized monitoring plan.
Overview of Biometrics services
- Study design – with our biostatisticians included from the start, we can ensure optimized sample size calculation and study data endpoints.
- eCRF set-up – development of an advanced and user-friendly eCRF according to CDASH with smart and adequate built-in edit checks facilitating real-time data cleaning. The set-up is managed by a dedicated Viedoc master-user who will make sure the eCRF is designed optimally for your trial and applicable users.
- Data management – supporting advanced centralized monitoring including validating data inconstancies via SAS-programmed checks, standard and customized reports as well as medical coding and clean file/database lock procedures.
- DSMB support – DSMB management and provision of study data for efficient data evaluation
- CDISC standards – study data packaged into CDISC-compliant standards (SDTM/ADaM) and/or sponsor-specific standards
- Biostatistics – knowledgeable and customer-focused support for randomization, statistical programming, statistical analyses and statistical reporting, ensuring correct data interpretation and clear conclusions
- Medical writing – proficient writing and quality control of clinical study reports, safety summaries and publication.
Contact me to learn how we can support your clinical development