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.

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Related topics: biocompatibility, biological safety, immunochemistry, rasH2, transgenic mouse, carcinogenicity, chonic toxicity, ISO 10993, reproductive toxicity, risk assessment, risk analysis, toxicology, toxicologist, AAMI, TAG 194, safety test, biosafety, statistics, sample size, biostatistics, equivalence, equivalent, better than, claim, performance, safety, efficacy, blackwelder, statistical plan, database design, data entry, double, Part 11, hypothesis, ISO 14155, EN 540, project management, sponsor, protocol, literature, investigator brochure, Cochrane Library, research, study, trial, studies, response variable, endpoint, case report form, investigator, site, center, technical writer, FDA, CDRH, 510k, 510(k), premarket notification, IDE, investigational device exemption, PMA, premarket approval, submission, approval, biomedical, corporate inteligence, medical market, corporate spy, SCIP, competitive inteligence.