Databean
Databean is a full-service clinical research organization (CRO) dedicated to supporting medtech and biotech start-ups. They focus on innovative trial designs, regulatory and clinical expertise, and custom IT solutions to facilitate the development and approval of novel medical technologies. Their mission is to foster rapid growth of life science companies by providing efficient, affordable, and scalable solutions, guiding them through complex regulatory and clinical processes to bring their products to market quickly.
Industries
Nr. of Employees
small (1-50)
Databean
Saint Augustine, Florida, United States, North America
Products
Cloud-based clinical trial management platform
A cloud-accessible research management system that centralizes study operational and data management tasks and provides remote access to trial data and analytics.
Cloud-based clinical trial management platform
A cloud-accessible research management system that centralizes study operational and data management tasks and provides remote access to trial data and analytics.
Services
Statistical strategy and analysis for clinical trials, including design, sample size justification, stratification, randomization and creation of statistical analysis plans using Bayesian and frequentist methods.
Regulatory pathway definition, preparation and management of premarket submissions and technical dossiers, regulatory negotiation and global regulatory strategy.
Database design/configuration, data dictionary integration, real-time data capture, eTMF management, data quality audits and production of technical and clinical reports.
Engineering consultancy for device testing, iterative design optimization and design evaluation during early feasibility and pivotal studies.
Oversight of trial adherence to quality standards and GCP, on-site/remote monitoring, risk assessments and reporting to regulatory and QA departments.
Operational management of clinical trials including vendor and site coordination, regulatory reporting, event reporting and integrated trial oversight.
Statistical strategy and analysis for clinical trials, including design, sample size justification, stratification, randomization and creation of statistical analysis plans using Bayesian and frequentist methods.
Regulatory pathway definition, preparation and management of premarket submissions and technical dossiers, regulatory negotiation and global regulatory strategy.
Database design/configuration, data dictionary integration, real-time data capture, eTMF management, data quality audits and production of technical and clinical reports.
Engineering consultancy for device testing, iterative design optimization and design evaluation during early feasibility and pivotal studies.
Oversight of trial adherence to quality standards and GCP, on-site/remote monitoring, risk assessments and reporting to regulatory and QA departments.
Operational management of clinical trials including vendor and site coordination, regulatory reporting, event reporting and integrated trial oversight.
Expertise Areas
- Clinical trial management
- Biostatistics and statistical analysis
- Regulatory strategy and submissions
- Data management and eClinical systems
Key Technologies
- Bayesian statistical methods
- Frequentist statistical methods
- Adaptive trial design
- Cloud-based clinical trial management systems