Phlexglobal are sponsoring, exhibiting and speaking at the 4th Clinical Trials Inspection Readiness Summit on 12-13 August 2015 in Philadelphia, US.
Inspections can occur at any time. The consequences of a failed inspection can be dire, including hefty fines, lost jobs and waning credibility.
Inspection readiness is more than a ‘one time’ event. In the best companies, the inspection readiness process is driven by people who excel at thinking ahead.
This means taking into account the constantly evolving variables of clinical research, including new staff, sites and vendors.
Thinking about undiscovered problems is the key to making sure all aspects of clinical trials are up to code and ensures all required documents are provided that prove the trial is GCP compliant.
The 4th Clinical Trials Inspection Readiness Summit presents life science industry professionals with case studies of peers who put in place proactive measures to reduce the risk of a failed inspection.
Effective clinical research documentation, FDA submissions, TMF processes and vendor management are critical to audit preparation.