Clinical Affairs
Databean maintains a highly experienced Clinical Affairs team that can get a 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 the tasks associated with project management and can easily integrate our services into pre-existing plans or offer a comprehensive management package to maximize project efficiency. Our single-service components or complete development programs include:
- 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 a modular-based offering is that clients pay for only those services that create value for them.
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.
If you would like to know more about our capabilities or have a project you would like to discuss please call 845 278 0576 or email us.