Taking the Stress Out of Preparing Investigator Sites for Regulatory Inspection

Inspection site preparations are stressful for everyone involved.  Clinical trials are challenging, and they take on a life of their own at each clinical site.  Are you ready to have a regulator look into your documentation? Sometimes you think you have everything covered, but a fresh set of eyes may uncover things you did not notice: missing or outdated trainings, missing communication to explain an adverse event, missing versions of protocols, pharmacy manuals, IP temperature logs to name a few. Preparing for inspections is not just about the Sponsor or the site, many times CRO’s are part of the equation and an important part of your storyboard activity. Pulling together all the players to ensure a cohesive story of your study can feel overwhelming.  Having an expert supporting your team in these endeavors can help identify where gaps are, and help you find the details that fell through the cracks. Have you considered the changing requirements and changes to systems? Let us help you prepare and de-stress at the same time while preparing for an inspection.  We have helped many sponsors and sites prepare for anticipated inspections, ensuring all the pieces that support the story of the study are in place and thereby taking the stress out of inspection preparation. For a detailed presentation that includes tips for preparing for an investigator site for regulatory inspection, join our prerecorded webinar! Preparing for the Inspection at the Investigator Site
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