Would you be ready if an unscheduled Inspector arrived at your site today? Or would you prefer a scheduled inspection? A non-compliance rating can have detrimental effect on all parties and all facilities involved. Despite this, a reactive approach is still being utilized.
Our clinical services include:
Regulatory Clinical Trial Applications (CTAs)
Informed Consent Forms
REB / IRB Approval
Clinical Trial Protocols and study reports
Clinical Documentation Development
Regulatory Inspection Readiness
Good Clinical Practices (GCP) govern the conduct of high-quality ethical research. Key ingredients for compliant trial conduct include:
A Proactive Approach
Sponsors are now seeking a more proactive approach for ensuring compliance. Since implementing in-house QA teams can be expensive, the use of third-party auditors in a targeted approach is an excellent option. Using AXSource consultants that are well versed in clinical research and have expertise in regulatory affairs and quality compliance, is the best approach. Having supported numerous companies in GCP, GLP, GMP, GDP and Pharmacovigilance, we know what inspectors look for and support the implementation of GxP framework, gap analyses and support customized training initiatives.