Whitepapers
Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation
Published: February 2020 by The Avoca Group
So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate — or even eliminate — the pain points associated with preparing for inspections. Learn More
Understanding the RTF Letter: Practical guidance on what the FDA is looking for, and how to avoid receiving one
Published: November 2019 by YourEncore
The business impact of the Refusal-To-File letter is always negative and frequently significant. However, there are many activities a company can undertake to reduce the likelihood of receiving an RTF letter. Learn More
