Clinical Affairs
Databean is made up of highly experienced clinical affairs and data management professionals that can get your project up and running in the most efficient and cost effective way. We are experts in strategic planning and management of the day-to-day operations of small and large scale clinical trials.
To maximize productivity we streamline tasks associated with project management and can easily integrate our services into your pre-existing plans or offer a comprehensive management package to maximize project efficiency.
Our single-service components or complete development programs include:
- SOP development
- Site selection
- Contract/budget negotiations and grant payments
- IRB approvals
- Reimbursement approvals via Medicare contractors (FI's)
- Master file management
- Site training and initiations
- Monitoring and closeouts
- Source data verification and storage
- AE/SAE/UADE reporting
- Oversight committee management
- Core lab protocol integration
- CRF storage and shipment for paper based trials
The benefit of this modular-based offering is that clients pay for only those services that create value for them.
Post Surveillance
The transition from clincal development to marketplace introduction is critical to the success of a product. We offer smart, seamless transition to post marketing surveillance studies during the critical planning stages of a pivotal trial. In addition, Databean is equipped to offer valuable reimbursement advice needed to optimize a product's potential and gain a competitive advantage.