Audits... |
Sometimes you need a second eye to take a look at things. We audit sites, CROs and sponsors — using template auditing plans based on FDA’s bioresearch monitoring program guides, data privacy and security rules, good clinical practices, and good business practices. We audit in either of two ways: 1) taking a "snap-shot" of what’s so, or 2) adding support and assistance to the snap-shot to bring a site into compliance. You define the purpose, we’ll meet the need. |