In a short (1-week) study the model, using either prophylactic or therapeutic dosing regimens, provides a variety of readouts including:
- Disease sign scores at termination: adhesions, ulceration and inflammation
- Lengths of ulcerated and inflamed areas of the small intestine
- Colon length and weight
- Body weights daily
- Collection and preservation of Small Intestine or sections (duodenum, jejunum, ileum)
- OPTIONAL: There are also optional items including histopathology on all or part of the collected small intestine (scored readings, blocks, slides, photomicrographs); and blood samples for exposure (plasma or serum). With our Project Team Approach, clients have the flexibility to make decisions on optional items at the end of a study.
As in all of our studies, each IBD study follows the same approach of active and well-coordinated team communications. At WBI the Study Sponsor is considered a member of the Project Team to be frequently appraised of project progress, data development and study observations. This approach provides a focus on project quality through close communication between the WBI Project Manager and the Study Sponsor.
The rapidly implemented steps in this team approach include -
- TELECONFERENCE:
Study Sponsor/WBI Project Team
- Draft Protocol: WBI Project Manager to
Study Sponsor for review/ revision/
acceptance
- Finalized Protocol and Project Schedule
- Rapid start-up
- Frequent Project Status Reports
- E-mail Data Reports & Statistical Analysis
- Draft Final Report: detailed; audited; for
Study Sponsor Review
- Final Report (electronic and paper)
Our emphasis is careful quality control of the Project through internal controls and communications with the Study Sponsor and speedy implementation from rapid start-up to expedited delivery of a comprehensive Final Report.
For further information on this or any of our disease models please contact us. Thank you.
