Services

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.

 

Therapeutic Areas:
  • Heart Failure
  • Cardiovascular
  • Pulmonary
  • Obesity
  • Diabetes
  • Orthopedic
  • Neurology
  • Rehab Medicine
  • Audiology